The Cetirizine an their 150 adverse effects. !!
La Cetirizina y sus 150 efectos adversos. !!
===================
Hello friends of the network, DERMAGIC EXPRESS with another hot topic THE
CETIRIZINE AND THEIR 150 ADVERSE EFFECTS. Maybe when you read the title of
the review you did not believe it, that a drug so popular and used today
like this, has so many adverse effects.
The first thing I am going to say to all MEDICAL and non MEDICAL audience is that this article that I am launching today has a single purpose, and is to make you understand, to make known ALL the vast majority of ADVERSE EFFECTS related to The use of CETIRIZINE.
There are no commercial intentions, nor are they paying me for it, either discredit the laboratories that market this product. It is important that EVERYBODY UNDERSTAND this. As I publish LORATADINE AND THEIR 110 ADVERSE EFFECTS, I do it today with CETIRIZINE, and tomorrow or later I will do it with other medicines.
Another detail: if you do an intense search on this medication in the BEST DATABASES placed on the network, YOU ARE NOT GOING TO GET what I am going to put here. Then you're going to ask. Where do I get the information?
The answer is simple. EVERY LABORATORY BEFORE MARKETING a product must go through an "APPROVAL" state by the FDA (Food and Drug Administration), and them MUST REPORT, EVERYONE, I repeat ALL, the adverse effects of the product found on "PRELIMINARY " studies. Then, the information is in the FDA, which forces the LABORATORY to publish the good and bad of the product.
Now I tell you the HISTORY of the CETIRIZINE:
CETTRIZINE (HYDROCHLORIDE) is the active metabolite of HYDROXYCIN, born in 1.995, Tablets, as a second-generation ANTIHISTAMINIC, an H 1 -receptor antagonist, to treat diseases such as RHINITIS, ALLERGIES, HAY FEVER, ATOPIC DERMATITIS and other allergic conditions, such as PRURITUS (itching), ANGIOEDEMA and URTICARIA.
In 1.996, the Syrup presentation was approved for use in children. In 2.001 the combination of CETIRIZINE PLUS PSEUDOEPHEDRINE was approved, under medical prescription for the treatment of allergies. On November 9, 2007, this presentation is approved for OTC (Over the Country).
On April 30, 2.010, the FDA decided to withdraw from the market the LIQUIDS PRESENTATION for children and infants of the CETIRIZIN (ZYRTEC), also in that decision were included TYLENOL, MOTRIN and BENADRYL.
As of March 2.001, the AERS database (ADVERSE EVENTS REPORT SYSTEM) contained 3,096 adverse event events related to CETIRIZINE, the most relevant of which were: INEFFECTIVENESS OF THE MEDICINE, and PSYCHIATRIC EVENTS (39.3%), which I describe below : (In parentheses, the number of cases)
1.) Sedation (306).
2.) Headache (107).
3.) insomnia (98)
4. Syncope (54)
5.) Agitation (49).
6.) Nervousness (48).
7.) Seizures (44).
8.) Confusion (41).
9.) Anxiety (40).
10.) Paresthesia (38).
11.) Trembling (38).
12.) Abnormal dreams (37).
13.) Depersonalization (34).
14.) Discomfort (34).
15.) Depression (32).
16.) Hyperkinetic syndrome (27).
17.) Abnormal thinking (26).
18.). Loss of consciousness (25).
19. Hallucinations (23).
20.) There were 16 deaths, four (4) of which were possibly attributable to a primary nervous system or psychiatric event.
21.) Suicide (1) A patient committed suicide when he felt confused, depressed, and had hallucinations after taking cetirizine.
Among serious events, three categories were identified as potential areas of concern: SEIZURES, VENTRICULAR ARRHYTHMIA AND TROMBOCYTOPENIA.
In April 2.000, 16 cases of new SEIZURES related to the use of CETIRIZINE, 27 cases of VENTRICULAR ARRHYTHMIAS, sudden cardiac death and prolongation of the QT interval were reported; And 11 cases of TROMBOCYTOPENIA.
Before I PLACE the side effects of this popular drug, I will remind you that ALL MEDICINE has its adverse effects, especially those who use them for a long time. This is my real WARNING TO ALL, few days of treatment, or rational use of medicine, minor side effects.
But the "CALL OF DUTY" is to inform you of these events reported, especially to those patients who indiscriminately use the medicines and to understand once again that ALL MEDICINE HAS ITS ADVERSE EFFECTS, and you must be vigilant.
Now I place the list of ADVERSE EFFECTS REPORTED by the FDA, for the medicinal products that contain CETIRIZINE:
The 150 ADVERSE EFFECTS OF CETIRIZINE (FDA):
========================================
ADVERSE EFFECTS REPORTED BY THE FDA IN 3.982 ADULTS AND 659 CHILDREN BETWEEN 6 AND 11 YEARS OF AGE, DURING 6 MONTHS OF STUDY:
AUTONOMIC NERVOUS SYSTEM:
1.) Anorexia, redness
2.) Increased salivation
3.) Urinary retention.
CARDIOVASCULAR:
4.) Heart Failure
5.) Hypertension
6.) palpitations.
7.) tachycardia.
8.) Torsades de points (ventricular arrhythmia)
9.) Cardiac arrhythmia.
10.) Cardiac sudden death.
11.) Prolongation of the QT interval.
CENTRAL AND PERIPHERAL NERVOUS SYSTEMS:
12.) Anomaly of coordination
13.) Ataxia.
14.) Confusion
15.) Dysphonia
16.) Hyperesthesia
17.) Hyperkinesia
18.) Hypertonia.
19.) Hypoesthesia.
20.) Legs cramps.
21.) Migraine.
22.) Myelitis.
23.) Paralysis.
24.) Paresthesia.
25.) Ptosis.
26.) Syncope.
27.) Tremor
28.) Twitching.
29.) Vertigo.
30.) Visual defect field.
GASTROINTESTINAL:
31.) Abnormal hepatic function.
32.) Aggravated tooth caries.
33.) Constipation.
34.) Dyspepsia.
35.) Eructation.
36.) Flatulence.
37) Gastritis.
38.) Hemorrhoids.
39.) Increased appetite.
40.) Melena.
41.) Rectal hemorrhage.
42.) Stomatitis including ulcerative stomatitis.
43.) Discoloration of the tongue.
44.) Edema of the tongue.
GENITOURINARY:
45.) Cystitis.
46.) Dysuria.
47.) Hematuria.
48.) Frequency of micturition: polyuria.
49.) Urinary incontinence.
50.) Urinary tract infection.
AUDITION AND VESTIBULAR:
51.) Deafness
52.) Earache.
53.) Ototoxicity.
54.) Tinnitus.
METABOLIC / NUTRITIONAL:
55.) Dehydration.
56.) Diabetes mellitus.
57.) Thirst.
MUSCULOSKELETAL:
58.) Arthralgia
59.) Arthritis.
60.) Aarthrosis
61.) Muscle weakness
62.) Myalgia.
PSYCHIATRIC:
63.) Abnormal thinking.
64.) Agitation.
65.) Amnesia.
66.) Anxiety.
67.) Decreased libido.
68.) Depersonalization.
69.) Depression.
70.) Emotional ability.
71.) Euphoria.
72.) Allteration of concentration.
73.) insomnia.
74.) Nervousness.
75). Paroniria: sleep disorder.
RESPIRATORY SYSTEM:
76.) Bronchitis
77.) Dyspnea.
78.) Hyperventilation.
79.) Increased sputum.
80.) Pneumonia.
81.) Rhinitis, sinusitis.
82.) Upper respiratory tract infection.
REPRODUCTIVE:
83.) Dysmenorrhea.
84.) Female breast pain.
85.) Intermenstrual bleeding.
86.) Leucorrhea.
87.) Menorrhagia.
88.) vaginitis.
RETICULO ENDOTHELIAL:
89.) Lymphadenopathy.
SKIN:
90.) Acne.
91.) Alopecia.
92.) Angioedema.
93.) Bullous eruption.
94.) Dermatitis.
95.) Dry skin.
96.) Erythematous eczema.
97.) Cutaneous eruption: Generalized exanthematous pustulosis.
98.) Urticaria.
99.) Furunculosis.
100.) Hyperkeratosis.
101.) Hypertrichosis.
102.) Increased Ssudoration.
103.) Maculopapular erection.
104.) Fixed drug eruption.
105.) Toxic photosensitivity reaction.
106.) Pruritus.
107.) Purple.
108.) Rash.
109.) Seborrhea.
110.) Cutaneous nodule disorder.
SPECIAL SENSES:
111.) Parosmia.
112.) Loss of taste.
113.) Perversion of taste.
VISUAL:
114.) Blindness.
115.) Conjunctivitis.
116.) Pain in the eyes.
117.) Glaucoma.
118.) loss of eye accommodation: oculogyric crisis.
119.) Hemorrhage.
120.) Xerophthalmia.
BODY AS A WHOLE:
121.) Accidental injury.
122.) Asthenia.
123.) Back pain
124.) Chest pain.
125.) Enlargement of the abdomen.
126.) Edema of the face.
127.) Fever.
128.) Generalized edema.
129.) Hot flushes.
130.) Weight gain.
131.) Edema of the legs.
132.) General malaise.
133.) Nasal polyp.
134.) Pain.
135.) Paleness.
136.) Periorbital edema.
137.) Peripheral edema.
138.) Rigors, severe hypotension.
HEMATOLOGY:
139.) Thrombocytopenia.
140.) Hemolytic anemia.
HEPATIC:
141.) increase of transaminase enzymes. (Reversible)
142.) Cholestasis.
143.) sclerosing cholangitis
144.) Acute and severe hepatitis.
145.) Elevated bilirubin.
RENAL:
146.) Glomerulonephritis.
OTHERS:
147.) Fetal death.
148.) Orofacial dyskinesia.
149.) Anaphylaxis.
150.) Seizures.
If you ask me my opinion about CETIRIZINE, I tell you that like LORATADINE, it is a GOOD MEDICINE. In 15 years experience with it, the most observed ADVERSE EFFECTS: Drowsiness, drug ineffectiveness, transient increase in liver enzymes, insomnia and cardiac arrhythmia. I'VE NEVER OBSERVED DEATH OR SUICIDE.
I am also tell you that For the year 2.001 THE LEVOCETIRIZINE, a third-generation antihistamine derived from CETIRIZINE, was released to the market, and according to its manufacturers with many fewer adverse effects, but in effectiveness according to scientific studies, the difference is little. In another opportunity I will tell you about this medicine.
As an interesting fact, learn that scientists today are focusing their studies on the presence of pharmaceuticals products in aquatic ecosystems and their impact on living organisms. There I placed a study on the possible toxicity of CETIRIZINE in a type of musel (Mytilus galloprovincialis), reference 18.
In the references and photos the facts ...
Greetings to all.
Dr. José Lapenta.
The first thing I am going to say to all MEDICAL and non MEDICAL audience is that this article that I am launching today has a single purpose, and is to make you understand, to make known ALL the vast majority of ADVERSE EFFECTS related to The use of CETIRIZINE.
There are no commercial intentions, nor are they paying me for it, either discredit the laboratories that market this product. It is important that EVERYBODY UNDERSTAND this. As I publish LORATADINE AND THEIR 110 ADVERSE EFFECTS, I do it today with CETIRIZINE, and tomorrow or later I will do it with other medicines.
Another detail: if you do an intense search on this medication in the BEST DATABASES placed on the network, YOU ARE NOT GOING TO GET what I am going to put here. Then you're going to ask. Where do I get the information?
The answer is simple. EVERY LABORATORY BEFORE MARKETING a product must go through an "APPROVAL" state by the FDA (Food and Drug Administration), and them MUST REPORT, EVERYONE, I repeat ALL, the adverse effects of the product found on "PRELIMINARY " studies. Then, the information is in the FDA, which forces the LABORATORY to publish the good and bad of the product.
Now I tell you the HISTORY of the CETIRIZINE:
CETTRIZINE (HYDROCHLORIDE) is the active metabolite of HYDROXYCIN, born in 1.995, Tablets, as a second-generation ANTIHISTAMINIC, an H 1 -receptor antagonist, to treat diseases such as RHINITIS, ALLERGIES, HAY FEVER, ATOPIC DERMATITIS and other allergic conditions, such as PRURITUS (itching), ANGIOEDEMA and URTICARIA.
In 1.996, the Syrup presentation was approved for use in children. In 2.001 the combination of CETIRIZINE PLUS PSEUDOEPHEDRINE was approved, under medical prescription for the treatment of allergies. On November 9, 2007, this presentation is approved for OTC (Over the Country).
On April 30, 2.010, the FDA decided to withdraw from the market the LIQUIDS PRESENTATION for children and infants of the CETIRIZIN (ZYRTEC), also in that decision were included TYLENOL, MOTRIN and BENADRYL.
As of March 2.001, the AERS database (ADVERSE EVENTS REPORT SYSTEM) contained 3,096 adverse event events related to CETIRIZINE, the most relevant of which were: INEFFECTIVENESS OF THE MEDICINE, and PSYCHIATRIC EVENTS (39.3%), which I describe below : (In parentheses, the number of cases)
1.) Sedation (306).
2.) Headache (107).
3.) insomnia (98)
4. Syncope (54)
5.) Agitation (49).
6.) Nervousness (48).
7.) Seizures (44).
8.) Confusion (41).
9.) Anxiety (40).
10.) Paresthesia (38).
11.) Trembling (38).
12.) Abnormal dreams (37).
13.) Depersonalization (34).
14.) Discomfort (34).
15.) Depression (32).
16.) Hyperkinetic syndrome (27).
17.) Abnormal thinking (26).
18.). Loss of consciousness (25).
19. Hallucinations (23).
20.) There were 16 deaths, four (4) of which were possibly attributable to a primary nervous system or psychiatric event.
21.) Suicide (1) A patient committed suicide when he felt confused, depressed, and had hallucinations after taking cetirizine.
Among serious events, three categories were identified as potential areas of concern: SEIZURES, VENTRICULAR ARRHYTHMIA AND TROMBOCYTOPENIA.
In April 2.000, 16 cases of new SEIZURES related to the use of CETIRIZINE, 27 cases of VENTRICULAR ARRHYTHMIAS, sudden cardiac death and prolongation of the QT interval were reported; And 11 cases of TROMBOCYTOPENIA.
Before I PLACE the side effects of this popular drug, I will remind you that ALL MEDICINE has its adverse effects, especially those who use them for a long time. This is my real WARNING TO ALL, few days of treatment, or rational use of medicine, minor side effects.
But the "CALL OF DUTY" is to inform you of these events reported, especially to those patients who indiscriminately use the medicines and to understand once again that ALL MEDICINE HAS ITS ADVERSE EFFECTS, and you must be vigilant.
Now I place the list of ADVERSE EFFECTS REPORTED by the FDA, for the medicinal products that contain CETIRIZINE:
The 150 ADVERSE EFFECTS OF CETIRIZINE (FDA):
========================================
ADVERSE EFFECTS REPORTED BY THE FDA IN 3.982 ADULTS AND 659 CHILDREN BETWEEN 6 AND 11 YEARS OF AGE, DURING 6 MONTHS OF STUDY:
AUTONOMIC NERVOUS SYSTEM:
1.) Anorexia, redness
2.) Increased salivation
3.) Urinary retention.
CARDIOVASCULAR:
4.) Heart Failure
5.) Hypertension
6.) palpitations.
7.) tachycardia.
8.) Torsades de points (ventricular arrhythmia)
9.) Cardiac arrhythmia.
10.) Cardiac sudden death.
11.) Prolongation of the QT interval.
CENTRAL AND PERIPHERAL NERVOUS SYSTEMS:
12.) Anomaly of coordination
13.) Ataxia.
14.) Confusion
15.) Dysphonia
16.) Hyperesthesia
17.) Hyperkinesia
18.) Hypertonia.
19.) Hypoesthesia.
20.) Legs cramps.
21.) Migraine.
22.) Myelitis.
23.) Paralysis.
24.) Paresthesia.
25.) Ptosis.
26.) Syncope.
27.) Tremor
28.) Twitching.
29.) Vertigo.
30.) Visual defect field.
GASTROINTESTINAL:
31.) Abnormal hepatic function.
32.) Aggravated tooth caries.
33.) Constipation.
34.) Dyspepsia.
35.) Eructation.
36.) Flatulence.
37) Gastritis.
38.) Hemorrhoids.
39.) Increased appetite.
40.) Melena.
41.) Rectal hemorrhage.
42.) Stomatitis including ulcerative stomatitis.
43.) Discoloration of the tongue.
44.) Edema of the tongue.
GENITOURINARY:
45.) Cystitis.
46.) Dysuria.
47.) Hematuria.
48.) Frequency of micturition: polyuria.
49.) Urinary incontinence.
50.) Urinary tract infection.
AUDITION AND VESTIBULAR:
51.) Deafness
52.) Earache.
53.) Ototoxicity.
54.) Tinnitus.
METABOLIC / NUTRITIONAL:
55.) Dehydration.
56.) Diabetes mellitus.
57.) Thirst.
MUSCULOSKELETAL:
58.) Arthralgia
59.) Arthritis.
60.) Aarthrosis
61.) Muscle weakness
62.) Myalgia.
PSYCHIATRIC:
63.) Abnormal thinking.
64.) Agitation.
65.) Amnesia.
66.) Anxiety.
67.) Decreased libido.
68.) Depersonalization.
69.) Depression.
70.) Emotional ability.
71.) Euphoria.
72.) Allteration of concentration.
73.) insomnia.
74.) Nervousness.
75). Paroniria: sleep disorder.
RESPIRATORY SYSTEM:
76.) Bronchitis
77.) Dyspnea.
78.) Hyperventilation.
79.) Increased sputum.
80.) Pneumonia.
81.) Rhinitis, sinusitis.
82.) Upper respiratory tract infection.
REPRODUCTIVE:
83.) Dysmenorrhea.
84.) Female breast pain.
85.) Intermenstrual bleeding.
86.) Leucorrhea.
87.) Menorrhagia.
88.) vaginitis.
RETICULO ENDOTHELIAL:
89.) Lymphadenopathy.
SKIN:
90.) Acne.
91.) Alopecia.
92.) Angioedema.
93.) Bullous eruption.
94.) Dermatitis.
95.) Dry skin.
96.) Erythematous eczema.
97.) Cutaneous eruption: Generalized exanthematous pustulosis.
98.) Urticaria.
99.) Furunculosis.
100.) Hyperkeratosis.
101.) Hypertrichosis.
102.) Increased Ssudoration.
103.) Maculopapular erection.
104.) Fixed drug eruption.
105.) Toxic photosensitivity reaction.
106.) Pruritus.
107.) Purple.
108.) Rash.
109.) Seborrhea.
110.) Cutaneous nodule disorder.
SPECIAL SENSES:
111.) Parosmia.
112.) Loss of taste.
113.) Perversion of taste.
VISUAL:
114.) Blindness.
115.) Conjunctivitis.
116.) Pain in the eyes.
117.) Glaucoma.
118.) loss of eye accommodation: oculogyric crisis.
119.) Hemorrhage.
120.) Xerophthalmia.
BODY AS A WHOLE:
121.) Accidental injury.
122.) Asthenia.
123.) Back pain
124.) Chest pain.
125.) Enlargement of the abdomen.
126.) Edema of the face.
127.) Fever.
128.) Generalized edema.
129.) Hot flushes.
130.) Weight gain.
131.) Edema of the legs.
132.) General malaise.
133.) Nasal polyp.
134.) Pain.
135.) Paleness.
136.) Periorbital edema.
137.) Peripheral edema.
138.) Rigors, severe hypotension.
HEMATOLOGY:
139.) Thrombocytopenia.
140.) Hemolytic anemia.
HEPATIC:
141.) increase of transaminase enzymes. (Reversible)
142.) Cholestasis.
143.) sclerosing cholangitis
144.) Acute and severe hepatitis.
145.) Elevated bilirubin.
RENAL:
146.) Glomerulonephritis.
OTHERS:
147.) Fetal death.
148.) Orofacial dyskinesia.
149.) Anaphylaxis.
150.) Seizures.
If you ask me my opinion about CETIRIZINE, I tell you that like LORATADINE, it is a GOOD MEDICINE. In 15 years experience with it, the most observed ADVERSE EFFECTS: Drowsiness, drug ineffectiveness, transient increase in liver enzymes, insomnia and cardiac arrhythmia. I'VE NEVER OBSERVED DEATH OR SUICIDE.
I am also tell you that For the year 2.001 THE LEVOCETIRIZINE, a third-generation antihistamine derived from CETIRIZINE, was released to the market, and according to its manufacturers with many fewer adverse effects, but in effectiveness according to scientific studies, the difference is little. In another opportunity I will tell you about this medicine.
As an interesting fact, learn that scientists today are focusing their studies on the presence of pharmaceuticals products in aquatic ecosystems and their impact on living organisms. There I placed a study on the possible toxicity of CETIRIZINE in a type of musel (Mytilus galloprovincialis), reference 18.
In the references and photos the facts ...
Greetings to all.
Dr. José Lapenta.
EDITORIAL ESPAÑOL
===================
Hola amigos de la red, DERMAGIC EXPRESS con otro tema bien caliente LA
CETIRIZINA Y SUS 150 EFECTOS ADVERSOS. Quizá cuando leíste el titulo de la
revisión no lo creíste, que un medicamento tan popular y utilizado hoy día como
este, tenga tantos efectos adversos.
Lo primero que voy a decir a toda la audiencia MEDICA y NO MEDICA, es que este
articulo que hoy estoy lanzado a la red, tiene una sola finalidad, y es hacerte
entender, dar a conocer TODOS la gran mayoría de los EFECTOS ADVERSOS
relacionados con el uso de la CETIRIZINA.
No hay intensiones comerciales, ni me están pagando por ello, y mucho menos
desprestigiar a los laboratorios que comercializan este producto. Es importante
que TODOS ENTIENDAN esto. Así como publique LA LORATADINA Y SUS 110 EFECTOS ADVERSOS, hoy lo hago con la CETIRIZINA, y mañana o pasado lo hare con otros
medicamentos.
Otro detalle, si tú haces una búsqueda intensa sobre este medicamento en las
MEJORES BASES DE DATOS colocadas en la red, NO TE VAS A CONSEGUIR lo que yo te
voy a poner acá. Entonces te vas a preguntar. De donde saque la información?
La respuesta es sencilla TODO LABORATORIO ANTES DE COMERCIALIZAR un producto
debe pasar por un estado de "APROBACION" por la FDA (Administración de Alimentos
y Medicinas), y debe REPORTAR, TODOS, repito TODOS, los efectos adversos del
producto en sus estudios "PRELIMINARES”. Entonces, la información está en la
FDA, la cual obliga al LABORATORIO a publicar lo bueno y lo malo del producto.
Así de simple es.
Ahora te cuento la HISTORIA de la CETIRIZINA:
LA CETTRIZINA (CLORHIDRATO) es el metabolito activo de la HIDROXICINA, nace en
él año 1.995, presentación en tabletas, como ANTIHISTAMINICO de segunda
generación, antagonista de los receptores H1, para tratar enfermedades como la
RINITIS, ALERGIAS, FIEBRE DEL HENO, DERMATITIS ATOPICA y otros estados alérgicos,
como el PRURITO (picazón), ANGIOEDEMA y URTICARIA.
En él año 1.996 es aprobada la presentación en JARABE para uso en niños. En el
año 2.001 se aprueba la combinación de CETIRIZINA MAS PSEUDOEFEDRINA, bajo
receta médica para el tratamiento de las alergias. El 9 de Noviembre del año
2.007 esta presentación es aprobada para la libre venta OTC (Over the country).
En Abril 30, del 2.010 La FDA decide retirar del mercado LA PRESENTACION EN
JARABE para niños y lactantes de la CETIRIZINA (ZYRTEC), también en esa decisión
fueron incluidos TYLENOL, MOTRIN y BENADRYL.
Para Marzo del 2.001 la base de datos AERS (ADVERSE EVENTS REPORT SYSTEM)
contenía 3.096 eventos de efectos adversos relacionados con la CETIRIZINA,
siendo los más relevantes, LA INEFECTIVIDAD DEL MEDICAMENTO, y EVENTOS
PSIQUIATRICOS (39,3%) que a continuación te describo: Entre paréntesis el número
de casos).
1.) Sdación (306).
2.) Cefalea (107).
3.) insomnio (98)
4.) Síncope (54)
5.) Agitación (49).
6.) Nerviosismo (48).
7.) Convulsiones (44).
8.) Confusión (41).
9.) Ansiedad (40).
10.) Parestesia (38).
11.) Temblores (38).
12.) Sueños anormales (37).
13.) Despersonalización (34).
14.) Malestar (34).
15.) Depresión (32).
16.) Síndrome hipercinético (27).
17.) Pensamiento anormal (26).
18.). Pérdida del conocimiento (25).
19.) Alucinaciones (23).
20.) Hubo 16 muertes, cuatro(4) de las cuales fueron posiblemente atribuibles a
un sistema nervioso primario o un evento psiquiátrico.
21.) Suicidio(1) Un paciente se suicidó cuando se sintió confundido, deprimido y
tuvo alucinaciones después de tomar cetirizina.
Entre los eventos graves, tres categorías fueron identificadas como posibles
áreas de preocupación: CONVULSIONES, ARRITMIAS VENTRICULARES Y TROMBOCITOPENIA.
Para Abril del 2.000 se reportaron 16 casos de nuevas CONVULSIONES relacionadas
al uso de la CETIRIZINA, 27 casos de ARRITMIAS VENTRICULARES, muerte súbita
cardíaca y prolongacion del intervalo QT; y 11 casos de TROMBOCITOPENIA.
Antes de colocarte LA LISTA de los efectos adversos de este popular medicamento,
te voy a recordar que TODA MEDICINA tiene sus efectos adversos, sobre todo
aquellas persona que las utilizan por largo tiempo. Esta es mi real ADVERTENCIA
A TODOS, pocos dias de tratamiento, o uso racional de la medicina, menores seran
los efectos secundarios.
Pero el "LLAMADO DEL DEBER" es informarte de estos eventos reportados, sobre
todo a aquellos pacientes que utilizan indiscriminadamente las medicinas y para
que entiendas una vez mas, que TODA MEDICINA TIENE SUS EFECTOS ADVERSOS, y debes
estar vigilante.
Ahora te coloco la lista de los EFECTOS ADVERSOS REPORTADOS POR LA FDA, para el
medicamento CETIRIZINA.
LOS 150 EFECTOS ADVERSOS DE LA CETIRIZINA (FDA):
================================================
EFECTOS ADVERSOS REPORTADOS POR LA FDA EN 3.982 ADULTOS Y 659 NIÑOS ENTRE 6 Y 11
AÑOS DE EDAD, DURANTE 6 MESES DE ESTUDIO:
SISTEMA NERVIOSO AUTONOMO:
1.) Anorexia, enrojecimiento
2.) Aumento de la salivación
3.) Retención urinaria.
CARDIOVASCULAR:
4.) Insuficiencia cardiaca
5.) Hipertensión
6.) palpitaciones.
7.) taquicardia.
8.) Torsades de points (arritmia Ventricular)
9.) Arritmia cardiaca.
10.) Muerte cardiaca súbita
11.) Prolongación del intervalo QT.
SISTEMAS NERVIOSOS CENTRAL Y PERIFERICO:
12.) Anomalía de la coordinación
13.) Ataxia.
14.) Confusión
15.) Disfonía
16.) Hiperestesia
17.) Hiperquinesia
18.) Hipertonía.
19.) Hipoestesia.
20.) Calambres en las piernas.
21.) Migraña.
22.) Mielitis.
23.) Parálisis.
24.) Parestesia.
25.) Ptosis.
26.) Síncope.
27.) Temblor
28.) Espasmos.
29.) vértigo.
30.) Defecto del campo visual.
GASTROINTESTINAL:
31.) Función hepática anormal.
32.) Caries dental agravada.
33.) Estreñimiento.
34.) Dispepsia.
35.) Eructación.
36.) Flatulencia.
37.) Gastritis.
38.) Hemorroides.
39.) Aumento del apetito.
40.) Melena.
41.) Hemorragia rectal.
42.) Estomatitis incluyendo estomatitis ulcerativa.
43.) Decoloración de la lengua.
44.) Edema de la lengua.
GENITOURINARIO:
45.) Cistitis.
46.) Disuria.
47.) Hematuria.
48.) Frecuencia de micción: poliuria.
49.) Incontinencia urinaria.
50.) Infección del tracto urinario.
AUDICION Y VESTIBULAR:
51.) Sordera
52.) Dolor de oído.
53.) Ototoxicidad.
54.) Tinnitus.
METABOLISMO / NUTRICIONAL:
55.) Deshidratación.
56.) Diabetes mellitus.
57.) Sed.
MUSCULOESQUELETICO:
58.) Artralgia
59.) Artritis.
60.) Artrosis
61.) Debilidad muscular
62.) Mialgia.
PSIQUIATRICOS:
63.) Pensamiento anormal.
64.) Agitación.
65.) Amnesia.
66.) Ansiedad.
67.) Disminución de la libido.
68.) Despersonalización.
69.) Depresión.
70.) Labilidad emocional.
71.) Euforia.
72.) Alteración de la concentración.
73.) insomnio.
74.) Nerviosismo.
75.) Paroniria: trastorno del sueño.
SISTEMA RESPIRATORIO:
76.) Bronquitis
77.) Disnea.
78.) Hiperventilación.
79.) Aumento del esputo.
80.) Neumonía.
81.) Rinitis, sinusitis.
82.) Infección del tracto respiratorio superior.
REPRODUCCION:
83.) Dismenorrea.
84.) Dolor de seno femenino.
85.) Hemorragia intermenstrual.
86.) Leucorrea.
87.) Menorragia.
88.) vaginitis.
RETICULOENDOTELIAL:
89.) Linfadenopatía.
PIEL:
90.) Acné.
91.) Alopecia.
92.) Angioedema.
93.) Erupción ampollosa.
94.) Dermatitis.
95.) Piel seca.
96.) Eczema eritematoso.
97.) Erupción cutánea: Pustulosis Exantematosa generalizada.
98.) Urticaria.
99.) Forunculosis.
100.) Hiperqueratosis.
101.) Hipertricosis.
102.) Sudoración aumentada.
103.) Erupción maculopapular.
104.) Erupción fija medicamentosa.
105.) Reacción de foto sensibilidad tóxica.
106.) Prurito.
107.) Púrpura.
108.) Sarpullido.
109.) Seborrea.
110.) Trastorno nódulo cutáneo
SENTIDOS ESPECIALES:
111.) Parosmia.
112.) Pérdida del gusto.
113.) Perversión del gusto.
VISION:
114.) Ceguera.
115.) Conjuntivitis.
116.) Dolor en los ojos.
117.) Glaucoma.
118.) pérdida de acomodación ocular: crisis oculogiricas.
119.) Hemorragia.
120.) Xeroftalmia.
CUERPO COMO UN TODO:
121.) Lesión accidental.
122.) Astenia.
123.) Dolor de espalda
124.) Dolor de pecho.
125.) Agrandamiento del abdomen.
126.) Edema de la cara.
127.) Fiebre.
128.) Edema generalizado.
129.) Sofocos.
130.) Aumento de peso.
131.) Edema de las piernas.
132.) Malestar general.
133.) Pólipo nasal.
134.) Dolor.
135.) Palidez.
136.) Edema peri orbitario.
137.) Edema periférico.
138.) Rigores, hipotensión severa.
HEMATOLOGICOS:
139.) Trombocitopenia.
140.) Anemia Hemolítica.
HEPATICOS:
141.) Aumento de enzimas transaminasas. (Reversibles)
142.) Colestasis.
143.) colangitis esclerosante
144.) Hepatitis aguda y severa.
145.) Bilirrubina elevada.
RENAL:
146.) Glomerulonefritis.
OTROS:
147.) Muerte fetal.
148.) Discinesia oro facial.
149.) Anafilaxia.
150.) Convulsiones.
Si me preguntas mi opinion acerca de la CETIRIZINA, te digo que al igual que la
LORATADINA, es una BUENA MEDICINA. En 15 años de experiencia con ella los
EFECTOS ADVERSOS mas observados : Somnolencia, inefectividad del medicamento,
aumento transitorio de las enzimas hepaticas, insomnio y arritmia cardiaca.
NUNCA HE OBSERVADO MUERTE O SUICIDIO.
Te cuento tambien que Para el año 2.001 fue lanzado al mercado LA LEVOCETIRIZINA,
antihistaminico de tercera generacion derivado de la CETIRIZINA, segun sus
fabricantes con muchos menos efectos adversos, pero en efectividad segun
estudios cientificos es poca la diferencia. En otra oportunidad les hablare de
esta medicina.
Como dato interesante, enterate que los cientificos hoy dia estan centrando sus
estudios a la presencia de productos farmaceuticos en los ecosistemas acuaticos
y su impacto en los organismos vivientes. Alli te coloque un estudio sobre la
posible toxicidad de la CETIRIZINA en un tipo de mejillon (Mytilus
galloprovincialis), referencia 18.
En las referencias y fotos los hechos...
Saludos a todos.
Saludos a todos.
Dr. Jose Lapenta
===========================================================================
REFERENCIAS BIBLIOGRAFICAS / BIBLIOGRAPHICAL REFERENCES
============================================================================
1.) CETIRIZINE, FDA SUMMARY REPORT
2.) Recurrent acute hepatitis associated with use of cetirizine.
3.) Severe hepatitis in a primary sclerosing cholangitis patient receiving recent cetirizine therapy.
4.) Cetirizine-induce cholestasis.
5.) Cetirizine-induced acute generalized exanthematous pustulosis: a serious reaction to a commonly used drug.
6.) Fixed drug eruption to cetirizine with positive lesional patch tests to the three piperazine derivatives.
7.) [Torsades de pointes caused by cetirizine overdose].
8.) Oculogyric crisis in patients taking cetirizine.
9.) Cetirizine-induced dystonic movements.
10.) Involuntary movements associated with cetirizine use.
11.) Multiple fixed drug eruptions due to cetirizine.
12.) Urticaria to cetirizine.
13.) Cetirizine-associated delusions and depression in an 18-year-old woman.
14.) Cetirizine-induced urticaria masquerading as multiple drug intolerance syndrome.
15.) Acute interstitial nephritis secondary to long-term use of cetirizine for the treatment of urticaria pigmentosa.
16.) Cetirizine side effects
18.) Toxic effects of the antihistamine cetirizine in mussel Mytilus galloprovincialis.
19.) Model-predicted occurrence of multiple pharmaceuticals in Swedish surface waters and their flushing to the Baltic Sea.
20.) Development of novel elastic vesicle-based topical formulation of cetirizine dihydrochloride for treatment of atopic dermatitis.
21.) Review of cetirizine hydrochloride for the treatment of allergic disorders.
22.) Efficacy of second-generation antihistamines in patients with allergic rhinitis and comorbid asthma.
23.) Second-generation antihistamines in asthma therapy: is there a protective effect?
24.) Drug induced oromandibular dystonia: a case related to prolonged use of cetirizine.
25.) Loratadine versus cetirizine: assessment of somnolence and motivation during the workday.
26.) Maculopapular and urticarial eruption from cetirizine.
=============================================================
1.) CETIRIZINE, FDA SUMMARY REPORT
=============================================================
Source: The FDA
Cetirizine is an active metabolite of hydroxyzine, a currently marketed prescription antihistamine. In clinical trials cetirizine has been associated with somnolence at a rate slightly greater than that seen with placebo (13.7% in adults, 4.2% in children at a dose of 10 mg.
There are two approved formulations of cetirizine:
NDA 19-835: Cetirizine 5 mg (Zyrtec) tablets, approved December, 1995.
NDA 20-346: Cetirizine 1 mg/1 mL (Zyrtec Syrup), approved September, 1996.
Cetirizine tablets are currently labeled for use in adults and children age 12 years and above at a
dose of 5 to 10 mg once daily. Cetirizine Syrup is approved for use in children down to age 2 years. Approved dosing for children age 6 to 11 years is 5 to 10 mg once daily and for children age 2 to 5 years is 2.5 mg (2.5 ml Zyrtec Syrup) once daily.
The NDA reviews for these cetirizne formulations showed that at the labeled dose of 10 mg once daily, the most commonly reported events from placebo-controlled clinical trials included
somnolence (13.7% for cetirizine vs. 6.3% for placebo), fatigue (5.9% vs. 2.6%), and dry mouth
(5.0% vs. 2.3%). The frequency of reported psychiatric disorders after administration of cetirizine was twice that of placebo (18% compared to 9%) in placebo-controlled studies in adults. There was no gender difference.
A total of four clinical pharmacology studies were conducted prior to approval to ascertain the
potential effect of cetirizine on cardiac repolarization, specifically QTc. There was no evidence of QTc prolongation in three of these studies at doses up to six times the labeled dose of 10 mg for up to 7 days. A fourth study showed a 9.1 msec increase in QTc with cetirizine (ketoconazole alone showed an increase of 8.3 msec in the same study, the co-administration of the two was associated with a QTc of 17.4 msec). The validity of this finding has been questioned due to the absence of a known PK interaction between cetirizine and ketonconazole, the absence of preclinical data demonstrating an impact of cetirizine on QTc, and concerns about the reproducibility of this finding. There was no evidence of ECG changes supportive of a QTc effect in either the adult or the pediatric phase 3 controlled clinical trials conducted for product approval.
Additional drug-drug interaction studies have disclosed no significant impact of coadministration of ketoconazole or the macrolide antibiotics erythromycin or azithromycin on cetirizine levels. Other safety information from the approved package insert of potential relevance in an OTC setting include recommendations for dosing adjustment in patients with renal failure and hepatic insufficiency, and in geriatric patients (each because of reduced clearance of cetirizine in that patient population).
As of March, 2001, the AERS database contained a total of 3096 adverse event reports in association with products containing cetirizine. The most prevalent event categories were "drug ineffective" and adverse event terms encoding psychiatric events. Specifically, 39.3% of adverse reaction reports (n = 1216) for cetirizine included one or more nervous system or psychiatric terms. These included sedation (306), headache (107), insomnia (98), syncope (54), agitation (49), nervousness (48), convulsions (44), confusion (41), anxiety (40), paresthesia (38), tremor (38), abnormal dreams (37), depersonalization (34), malaise (34), depression (32), hyperkinetic syndrome (27), abnormal thinking (26), loss of consciousness (25), and hallucinations (23). There were 16 deaths, four of which were possibly attributable to a primary nervous system or psychiatric event. One patient committed suicide when he became confused, depressed and had hallucinations after taking cetirizine.
Among the serious events, three categories were identified as potential areas of concern: convulsions/seizures, ventricular arrhythmias, and thrombocytopenia. As of April 2000, there were 16 reports of new onset seizures temporally related to cetirizine administration. In 11 other cases, there was exacerbation of seizures after initiating treatment with cetirizine. Data are incomplete, but there was a positive dechallenge in 13 patients and a positive rechallenge in 4 patients, suggestive of causality.
As of April 2000, there were 27 cases of ventricular arrhythmias, sudden cardiac death and QT
prolongation temporally associated with cetirizine administration. About 50% if the patients had pre-existing cardiac disease or were taking a concomitant medication that could prolong the QT interval. Four patients were taking a medication that could induce an arrhythmia in a patient with pre-existing QT prolongation. Torsades de pointes was reported in 3 patients and ventricular tachycardia in 6 patients. Asymptomatic prolongation of the QT interval was noted in 4 patients and symptomatic prolongation in 6 patients. There were 5 fatalities in this group. The majority of these patients were adult women. In four patients, the event occurred the same day that treatment with cetirizine was initiated. Based on a careful review of these cases by FDA it appears that a causal relationship may be present between cetirizine and cardiac arrhythmias, however, the data are by no means conclusive.
There were 11 cases of thrombocytopenia possibly associated with cetirizine. Seven cases were
domestic and four were non-US. Seven of these cases were reported solely as thrombocytopenia, the remainder as ITP, TTP, or pancytopenia. The lowest platelet count reported was 1000, with three of the four cases reporting nadir levels less than 10,000. The outcomes include one death and seven patients that were hospitalized. Cetirizine and hydroxyzine have known cross-reactivity with the piperazines, and thrombocytopenia associated with piperazines has been reported in the literature. Based on a careful review of these data by FDA staff it appears that there may be a causal relationship between cetirizne and rare reports of thrombocytopenia; however,the data are not conclusive.
The published literature did not provide additional insight regarding the primary areas of safety
concern.
In conclusion, an extensive review of adverse event reports associated with use of cetirizine revealed possible associations between cetirizine and sedation, neuropsychiactric events, including seizures, cardiac arrhthmias, and thrombocytopenia There is a preponderance of neuropsychiatric adverse events, particularly sedation, which may exceed the rate of reporting of similar events for loratadine and fexofenadine The data are inconclusive with regard to a causal relationship between cetirizine and arrhythmias and thromobcytopenia
=======================================================================
2.) Recurrent acute hepatitis associated with use of cetirizine.
=======================================================================
Ann Pharmacother. 2004 Nov;38(11):1844-7. Epub 2004 Sep 21.
Pompili M1, Basso M, Grieco A, Vecchio FM, Gasbarrini G, Rapaccini GL.
Author information
1
Department of Internal Medicine, Università Cattolica del Sacro Cuore, Rome, Italy. mpompilii@rm.unicatt.it
Abstract
OBJECTIVE:
To describe a case of recurrent acute hepatitis related to the use of cetirizine, a selective histamine(1)-receptor antagonist approved for the treatment of common allergic diseases.
CASE SUMMARY:
A 26-year-old man was hospitalized with a week-long history of weakness, nausea, anorexia, and hyperchromic urine, which had developed after 6 days of therapy with oral cetirizine 10 mg/day for allergic rhinitis. Admission laboratory testing revealed evidence of acute hepatitis and seropositivity for liver-kidney microsome antibodies. Liver biopsy findings of diffuse portal tract and lobular inflammation with a prominent eosinophilic infiltrate were consistent with drug-related hepatitis. The patient was discharged after one week of treatment with tocopherol and glutathione. Three months after discharge, transaminase levels were normal. At 6 months, seropositivity for liver-kidney microsome antibodies was still present, but considerably less intense. The patient had suffered 2 previous episodes of "acute hepatitis of unknown origin," and both had occurred after cetirizine use.
DISCUSSION:
Use of the Naranjo probability scale indicated cetirizine as the probable cause of acute hepatitis, and the positivity for liver-kidney microsome antibodies is suggestive of an autoimmune mechanism for liver damage. As of September 13, 2004, ours is the fourth reported case of acute hepatitis associated with cetirizine and the second in which liver-kidney microsome antibodies have been documented.
CONCLUSIONS:
Although cetirizine is considered to have low potential for severe hepatic toxicity, the possibility that it can provoke autoimmune-mediated hepatotoxicity should be considered.
=============================================================
3.) Severe hepatitis in a primary sclerosing cholangitis patient receiving recent cetirizine therapy.
=============================================================
Jurawan R, Smith A.
N Z Med J. 2010 Feb 19;123(1309):106-7.
=============================================================
4.) Cetirizine-induce cholestasis.
=============================================================
J Clin Gastroenterol. 2000 Oct;31(3):250-3.
Fong DG1, Angulo P, Burgart LJ, Lindor KD.
Author information
1
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota 55905, USA.
Abstract
Cetirizine, a human metabolite of hydroxyzine, is a selective H1-receptor antagonist currently approved for the treatment of seasonal allergic rhinitis, perennial allergic rhinitis, and chronic urticaria. In U.S. clinical trials, transient reversible hepatic transaminase elevations were observed in <2% of patients during cetirizine therapy. We report a case of cetirizine-induced cholestasis in a 28-year-old man with no previous hepatobiliary disease after a 2-year period of taking cetirizine on a daily basis. The treatment of this patient included the use of ursodeoxycholic acid, as well as hydroxyzine, for symptomatic relief of pruritus. In light of the patient's clinical and biochemical improvement while using hydroxyzine, it appears that the hepatic metabolism of hydroxyzine to metabolites, including cetirizine, is not involved in the pathogenesis of this particular case of drug-induced hepatotoxicity. Cetirizine should be considered as a potential cause of drug-induced cholestasis.
=============================================================
5.) Cetirizine-induced acute generalized exanthematous pustulosis: a serious reaction to a commonly used drug.
=============================================================
Dermatol Online J. 2014 May 16;20(5):22613.
Badawi AH, Tefft K, Fraga GR, Liu DY1.
Author information
1
University of Kansas Medical Center.
Abstract
Acute generalized exanthematous pustulosis (AGEP) is an abrupt cutaneous adverse reaction usually in response to medications. It is generally a self-limiting disease if diagnosed promptly and the offending agent discontinued. Cetirizine, a commonly used anti-histamine medication for the treatment of allergic diseases has few reported side effects and is normally well-tolerated and effective. Herein, the first reported case of cetirizine induced AGEP is presented, followed by a discussion of the clinical and pathological aspects of this adverse cutaneous reaction to a widely used drug. Awareness of this reaction is vital owing to the extensive use of cetirizine and the importance of drug cessation once the reaction is identified. Lastly, other pustular cutaneous reactions may present similarly and therefore accurate identification of this disease can prevent unnecessary diagnostic testing.
=============================================================
6.) Fixed drug eruption to cetirizine with positive lesional patch tests to the three piperazine derivatives.
=============================================================
Int J Dermatol. 2007 Jul;46(7):760-2.
Cravo M1, Gonçalo M, Figueiredo A.
Author information
1
Clinic of Dermatology, University Hospital, Coimbra, Portugal. mariana.cravo@netcabo.pt
Abstract
BACKGROUND:
The H1-antihistamine cetirizine, a piperazine derivative widely used in daily practice, is rarely the cause of cutaneous drug reaction. Nevertheless, four cases of fixed drug eruption (FDE) as a result of this drug have been described recently. We present the case of a 45-year-old woman with a multilocalized FDE following oral intake of cetirizine for allergic rhinitis.
METHODS:
Patch testing with hydroxyzine 1% and 10% in petrolatum (Chemotechnique), and with powdered Zyrtec (cetirizine) and Xyzal (levocetirizine) pills, prepared at 20% in water and at 20% in petrolatum, was performed in both residual lesions and healthy skin.
RESULTS:
Positive results (++) to these drugs (24 h occlusion and readings at days 2 and 3) were obtained in residual lesions only. These results allowed us to confirm the drug responsible for this FDE and to study cross-reactions between antihistamines of the same chemical family.
CONCLUSIONS:
To the best of our knowledge, this is the first report of FDE to cetirizine with positive patch testing to hydroxyzine, cetirizine, and levocetirizine. This case highlights the importance of patch testing in the study of cutaneous drug reactions, namely FDE.
=============================================================
7.) [Torsades de pointes caused by cetirizine overdose].
=============================================================
Arch Mal Coeur Vaiss. 2005 Feb;98(2):157-61.
[Article in French]
Renard S1, Ostorero M, Yvorra S, Zerrouk Z, Bargas E, Bertocchio P, Pracchia S, Ebagosti A.
Author information
1
Département de Pathologies Cardiovasculaires, Centre Hospitalier Général de Martigues. renardsebastien@9online.fr
Abstract
Several therapeutic substances can cause torsades de pointes, especially if they prolong the QT interval and/or if there is an associated hypokalaemia. Certain second generation H1 antihistamines have been incriminated in the occurrence of such ventricular arrhythmias, such as terfenadine and astezimole, which have been withdrawn. Cetirizine, widely used in the treatment of allergic reactions, is a second generation H1 antihistamine with as yet no precautions of use regarding rhythm disturbances. No documented case of arrhythmia attributable to this drug has been reported. We report the case of a dialysed patient with chronic renal failure who had symptomatic episodes of torsades de pointes in the context of hypokalaemia and cetirizine overdose. In the light of this observation it would appear that the prescription of cetirizine is contra-indicated under such conditions.
=============================================================
8.) Oculogyric crisis in patients taking cetirizine.
=============================================================
Am J Ophthalmol. 2004 Feb;137(2):355-7.
Fraunfelder FW1, Fraunfelder FT.
Author information
1
Casey Eye Institute, Oregon Health and Science University, Portland, Oregon 97201, USA. eyedrug@ohsu.edu
Abstract
PURPOSE:
To report oculogyric crisis in patients receiving cetirizine and inform clinicians on the characteristics of this drug-induced ocular side effect.
METHODS:
For this retrospective, observational case series, case reports were collected from the National Registry of Drug-Induced Ocular Side Effects (Casey Eye Institute, Portland, Oregon). The World Health Organization Causality Assessment Guide of Suspected Adverse Reactions was used to categorize the cases.
RESULTS:
Nine cases were reported, with eight occurring in the pediatric age group. Dosage ranged from 5 to 10 mg orally and onset of symptoms ranged from 3 to 184 days. Six cases of oculogyric crisis had positive rechallenge data. Eight cases had complete neurologic consultation including radiographic studies.
CONCLUSIONS:
Cetirizine can cause oculogyric crisis, especially in the pediatric age group. Extensive neurologic workups may be avoided if clinicians recognize this drug-induced ocular side effect.
=============================================================
9.) Cetirizine-induced dystonic movements.
=============================================================
Neurology. 2006 Jan 10;66(1):143-4.
Rajput A1, Baerg K.
Author information
1
Division of Neurology, University of Saskatchewan, Saskatoon, SK S7N 0W8, Canada. rajputa@sask.usask.ca
=============================================================
10.) Involuntary movements associated with cetirizine use.
=============================================================
Am J Psychiatry. 2011 Aug;168(8):855. doi: 10.1176/appi.ajp.2011.11040534.
Romo CA, Joshi KG, Waters BM.
=============================================================
11.) Multiple fixed drug eruptions due to cetirizine.
=============================================================
Br J Dermatol. 2002 Nov;147(5):1025-6.
Inamadar AC, Palit A, Athanikar SB, Sampagavi VV, Deshmukh NS.
=============================================================
12.) Urticaria to cetirizine.
============================================================
J Investig Allergol Clin Immunol. 2002;12(2):136-7.
Tella R1, Gaig P, Bartra J, Garcia-Ortega P.
Author information
1
Allergy Unit, Hospital Universitari Joan XXIII, Tarragona, Spain.
Abstract
A patient with recurrent idiopathic urticaria reported exacerbations after treatment with cetirizine. Prick test to cetirizine was negative. Double-blind challenge tests with mizolastine, loratadine, fexofenadine, dexchlorpheniramine, ebastine, ketotifen, and placebo were negative, whereas hydroxyzine and its active metabolite, cetirizine, reproduced the urticaria. Identification of uncommon adverse reactions to H1 antihistamines is important, particularly because they may mimic the underlying disease.
=============================================================
13.) Cetirizine-associated delusions and depression in an 18-year-old woman.
=============================================================
Clin Neuropharmacol. 2013 May-Jun;36(3):96-7. doi: 10.1097/WNF.0b013e318290b9b2.
Garden BC1, Francois D.
Author information
1
Weill Cornell Medical College, New York Presbyterian Hospital, White Plains, NY, USA.
Abstract
INTRODUCTION:
Cetirizine is a second-generation H1 histamine receptor antagonist that is commonly used for symptomatic relief of hay fever and other allergies and can be combined with pseudoephedrine hydrochloride, a decongestant. The most common adverse effects include headache, nausea, nasopharyngitis, vomiting, and coughing.
OBJECTIVE:
To report on an adolescent 18-year-old woman who developed delusional thinking and depression after starting treatment with cetirizine.
CASE REPORT:
We report on an adolescent 18-year-old woman who developed delusional thinking and depression after starting treatment with cetirizine. Once cetirizine was discontinued, the patient returned to her clinical baseline.
CONCLUSIONS:
Physicians need to be aware of the potential psychiatric adverse effects associated with cetirizine.
=============================================================
14.) Cetirizine-induced urticaria masquerading as multiple drug intolerance syndrome.
==============================================================
Indian J Dermatol Venereol Leprol. 2015 Sep-Oct;81(5):537-9. doi: 10.4103/0378-6323.162338.
Singh S, Kumar P, Sharma VK1.
Author information
1
Department of Dermatology and Venereology, All India Institute of Medical Sciences, New Delhi, India.
=============================================================
15.) Acute interstitial nephritis secondary to long-term use of cetirizine for the treatment of urticaria pigmentosa.
==============================================================
Clin Exp Dermatol. 2013 Jan;38(1):100-1. doi: 10.1111/j.1365-2230.2012.04471.x. Epub 2012 Oct 22.
Raghavendran R, Shipman AR, Langman G, Vijayan S, Orpin SD.
==============================================================
16.) Cetirizine side effects
==============================================================
Source: Fda
The following events were observed infrequently (less than 2%), in either 3982 adults and
children 12 years and older or in 659 pediatric patients aged 6 to 11 years who received ZYRTEC
in U.S. trials, including an open adult study of six months duration. A causal relationship of these
infrequent events with ZYRTEC administration has not been established.
Autonomic Nervous System:
anorexia, flushing, increased salivation, urinary retention.
Cardiovascular:
cardiac failure, hypertension, palpitation, tachycardia.
Central and Peripheral Nervous Systems:
abnormal coordination, ataxia, confusion, dysphonia, hyperesthesia, hyperkinesia, hypertonia, hypoesthesia, leg cramps, migraine, myelitis,paralysis, paresthesia, ptosis, syncope, tremor, twitching, vertigo, visual field defect.
Gastrointestinal:
abnormal hepatic function, aggravated tooth caries, constipation, dyspepsia,
eructation, flatulence, gastritis, hemorrhoids, increased appetite, melena, rectal hemorrhage,
stomatitis including ulcerative stomatitis, tongue discoloration, tongue edema.
Genitourinary:
cystitis, dysuria, hematuria, micturition frequency, polyuria, urinary
incontinence, urinary tract infection.
Hearing and Vestibular:
deafness, earache, ototoxicity, tinnitus.
Metabolic/Nutritional: dehydration, diabetes mellitus, thirst.
Musculoskeletal:
arthralgia, arthritis, arthrosis, muscle weakness, myalgia.
Psychiatric:
abnormal thinking, agitation, amnesia, anxiety, decreased libido, depersonalization,
depression, emotional lability, euphoria, impaired concentration, insomnia, nervousness,
paroniria, sleep disorder.
Respiratory System:
bronchitis, dyspnea, hyperventilation, increased sputum, pneumonia,
respiratory disorder, rhinitis, sinusitis, upper respiratory tract infection.
Reproductive: dysmenorrhea, female breast pain, intermenstrual bleeding, leukorrhea,
menorrhagia, vaginitis.
Reticuloendothelial:
lymphadenopathy.
Skin:
acne, alopecia, angioedema, bullous eruption, dermatitis, dry skin, eczema, erythematous
rash, furunculosis, hyperkeratosis, hypertrichosis, increased sweating, maculopapular rash,
photosensitivity reaction, photosensitivity toxic reaction, pruritus, purpura, rash, seborrhea, skin
disorder, skin nodule, urticaria.
Special Senses:
parosmia, taste loss, taste perversion.
Vision:
blindness, conjunctivitis, eye pain, glaucoma, loss of accommodation, ocular
hemorrhage, xerophthalmia.
Body as a Whole:
accidental injury, asthenia, back pain, chest pain, enlarged abdomen, face
edema, fever, generalized edema, hot flashes, increased weight, leg edema, malaise, nasal polyp, pain, pallor, periorbital edema, peripheral edema, rigors.
Occasional instances of transient, reversible hepatic transaminase elevations have occurred
during cetirizine therapy. Hepatitis with significant transaminase elevation and elevated bilirubin
in association with the use of ZYRTEC has been reported.
In foreign marketing experience the following additional rare, but potentially severe adverse
events have been reported: anaphylaxis, cholestasis, glomerulonephritis, hemolytic anemia,
hepatitis, orofacial dyskinesia, severe hypotension, stillbirth, and thrombocytopenia.
==============================================
17.) Unbearable Pruritus After Withdrawal of (Levo)cetirizine
=================================================
Drug Saf Case Rep. 2016 Dec; 3: 16.
Published online 2016 Nov 26. doi: 10.1007/s40800-016-0041-9
Corine Ekhart,corresponding author Petra van der Horst, and Florence van Hunsel
Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH ’s Hertogenbosch, The Netherlands
Corine Ekhart, Phone: 0031-73-6469700, Email: ln.beral@trahke.c.
Abstract
Twelve cases of unbearable pruritus several days after withdrawal of (levo)cetirizine were reported to the Netherlands Pharmacovigilance Centre Lareb. Eleven reports concerned women and one report concerned a man, aged 19–58 years. These patients had been using these antihistamines continuously for months or years. They had tried to stop using antihistamines on several occasions but felt unable to withdraw the drug because of the unbearable maddening itch. Finally, slowly tapering the drug or using a short course of corticosteroids helped to withdraw (levo)cetirizine. The Naranjo assessment score ranged from two to four for all the cases, indicating a possible relationship.
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18.) Toxic effects of the antihistamine cetirizine in mussel Mytilus galloprovincialis.
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Teixeira M1, Almeida Â2, Calisto V1, Esteves VI1, Schneider RJ3, Wrona FJ4, Soares AM2, Figueira E2, Freitas R5.
Author information
1
Department of Chemistry & CESAM, University of Aveiro, 3810-193 Aveiro, Portugal.
2
Department of Biology & CESAM, University of Aveiro, 3810-193 Aveiro, Portugal.
3
BAM Federal Institute for Materials Research and Testing, Richard-Willstaetter-Str. 11, Berlin, Germany.
4
Department of Geography, University of Victoria, National Water Research Institute, STN CSC, Victoria, BC, Canada.
5
Department of Biology & CESAM, University of Aveiro, 3810-193 Aveiro, Portugal. Electronic address: rosafreitas@ua.pt.
Abstract
Recent studies have become increasingly focused on the assessment of pharmaceuticals occurrence in aquatic ecosystems, however the potential toxicity to non-target organisms is still largely unknown. The antihistamine cetirizine is a commonly used pharmaceutical, already detected in surface waters of marine aquatic systems worldwide. In the present study Mytilus galloprovincialis mussels were exposed to a range of cetirizine concentrations (0.3, 3.0, 6.0 and 12.0 μg/L), resembling moderate to highly contaminated areas, over 28 days. The responses of different biochemical markers were evaluated in mussels whole soft tissue, and included energy-related parameters (glycogen content, GLY; protein content, PROT; electron transport system activity, ETS), and oxidative stress markers (superoxide dismutase activity, SOD; catalase activity, CAT; glutathione S-transferases activity, GSTs; lipid peroxidation levels, LPO; reduced (GSH) and oxidized (GSSG) glutathione content). The results obtained demonstrated that with the increase of exposure concentrations mussels tended to increase their energy reserves and maintain their metabolic potential, which was significantly higher only at the highest concentration. Our findings clearly revealed that cetirizine inhibited the activity of GSTs and although induced the activity of antioxidant enzymes (SOD and CAT) mussels were not able to prevent cellular damages observed through the increase of LPO associated to the increase of exposure concentrations. Thus, this study confirmed that cetirizine induces toxic effects in Mytilus galloprovincialis, which, considering their trophic relevance, wide use as bioindicator and wide spatial distribution of this species, can result in ecological and economic negative impacts at a large scale.
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19.) Model-predicted occurrence of multiple pharmaceuticals in Swedish surface waters and their flushing to the Baltic Sea.
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Environ Pollut. 2017 Apr;223:595-604. doi: 10.1016/j.envpol.2017.01.062. Epub 2017 Jan 30.
Lindim C1, van Gils J2, Cousins IT3, Kühne R4, Georgieva D5, Kutsarova S6, Mekenyan O7.
Author information
1
ACES - Department of Environmental Science and Analytical Chemistry, Stockholm University, SE 10691, Stockholm, Sweden. Electronic address: claudia.lindim@aces.su.se.
2
Deltares, PO Box 177, 2600 MH Delft, The Netherlands. Electronic address: jos.vanGils@deltares.nl.
3
ACES - Department of Environmental Science and Analytical Chemistry, Stockholm University, SE 10691, Stockholm, Sweden. Electronic address: ian.cousins@aces.su.se.
4
Department of Ecological Chemistry, Helmholtz Centre for Environmental Research-UFZ, 04318 Leipzig, Germany. Electronic address: ralph.kuehne@ufz.de.
5
Laboratory of Mathematical Chemistry, University "Prof. As. Zlatarov", 8010 Bourgas, Bulgaria. Electronic address: denitsa_georgieva@btu.bg.
6
Laboratory of Mathematical Chemistry, University "Prof. As. Zlatarov", 8010 Bourgas, Bulgaria. Electronic address: stela_kutsarova@btu.bg.
7
Laboratory of Mathematical Chemistry, University "Prof. As. Zlatarov", 8010 Bourgas, Bulgaria. Electronic address: omekenya@btu.bg.
Abstract
An exposure assessment for multiple pharmaceuticals in Swedish surface waters was made using the STREAM-EU model. Results indicate that Metformin (27 ton/y), Paracetamol (6.9 ton/y) and Ibuprofen (2.33 ton/y) were the drugs with higher amounts reaching the Baltic Sea in 2011. 35 of the studied substances had more than 1 kg/y of predicted flush to the sea. Exposure potential given by the ratio amount of the drug exported to the sea/amount emitted to the environment was higher than 50% for 7 drugs (Piperacillin, Lorazepam, Metformin, Hydroxycarbamide, Hydrochlorothiazide, Furosemide and Cetirizine), implying that a high proportion of them will reach the sea, and below 10% for 27 drugs, implying high catchment attenuation. Exposure potentials were found to be dependent of persistency and hydrophobicity of the drugs. Chemicals with Log D > 2 had exposure potentials <10% regardless of their persistence. Chemicals with Log D < -2 had exposure potentials >35% with higher ratios typically achieved for longer half-lives. For Stockholm urban area, 17 of the 54 pharmaceuticals studied had calculated concentrations higher than 10 ng/L. Model agreement with monitored values had an r2 = 0.62 for predicted concentrations and an r2 = 0.95 for predicted disposed amounts to sea.
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20.) Development of novel elastic vesicle-based topical formulation of cetirizine dihydrochloride for treatment of atopic dermatitis.
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AAPS PharmSciTech. 2013 Dec;14(4):1284-93.
Goindi S, Kumar G, Kumar N, Kaur A.
Abstract
Cetirizine is a piperazine-derived second-generation antihistaminic drug recommended for treatment of pruritus associated with atopic dermatitis. The present investigation encompasses development of a nanosized novel elastic vesicle-based topical formulation of cetirizine dihydrochloride using combination of Phospholipon® 90G and edge activators with an aim to have targeted peripheral H1 antihistaminic activity. The formulation was optimized with respect to phospholipid/drug/charge inducer ratio along with type and concentration of edge activator. The optimized formulation was found to be satisfactory with respect to stability, drug content, entrapment efficiency, pH, viscosity, vesicular size, spreadability, and morphological characteristics. The ex vivo permeation studies through mice skin were performed using Franz diffusion cell assembly. It was found that the mean cumulative percentage amount permeated in 8 h was almost twice (60.001 ± 0.332) as compared to conventional cream (33.268 ± 0.795) and aqueous solution of drug (32.616 ± 0.969), suggesting better penetration and permeation of cetirizine from the novel vesicular delivery system. Further, therapeutic efficacy of optimized formulation was assessed against oxazolone-induced atopic dermatitis in mice. It was observed that the developed formulation was highly efficacious in reducing the itching score (4.75 itches per 20 min) compared to conventional cream (9.75 itches per 20 min) with profound reduction in dermal eosinophil count and erythema score. To conclude, a novel vesicular, dermally safe, and nontoxic topical formulation of cetirizine was successfully developed and may be used to treat atopic dermatitis after clinical investigation.
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21.) Review of cetirizine hydrochloride for the treatment of allergic disorders.
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Expert Opin Pharmacother. 2004 Jan;5(1):125-35.
Portnoy JM1, Dinakar C.
Author information
1
Children's Mercy Hospital, 2401 Gillham Road, Kansas City, MO 64108, USA. jportnoy@cmh.edu
Abstract
Cetirizine hydrochloride is an orally-active and selective histamine (H(1))-receptor antagonist. It is a second-generation antihistamine and a human metabolite of hydroxyzine. Therefore, its principal effects are mediated via selective inhibition of peripheral H(1) receptors. The antihistaminic activity of cetirizine has been documented in a variety of animal and human models. In vivo and ex vivo animal models have shown negligible anticholinergic and antiserotonergic activity. In clinical studies, however, dry mouth has been seen more commonly with cetirizine than with placebo. In vitro receptor binding studies have shown no measurable affinity for receptors other than H(1) receptors. Auto-radiographical studies with radiolabelled cetirizine in the rat have shown negligible penetration into the brain. Ex vivo experiments in the mouse have shown that systemically administered cetirizine does not significantly occupy cerebral H(1) receptors. Impairment of CNS function is comparable to other low-sedating antihistamines at the recommended dose of 10 mg/day for adults. It has anti-inflammatory properties that may play a role in asthma management. It does not interact with concomitantly administered medications, it has no cardiac adverse effects, and it does not appear to be associated with teratogenicity. Cetirizine is predominantly eliminated by the kidneys with a mean elimination half-life is 8.3 h. It is rapidly absorbed, and significant clinical inhibition of a wheal and flare response occurs in infants, children and adults within 20 min of a single oral dose and persists for 24 h. No tolerance to the wheal and flare response occurs even after 1 month of daily treatment. The clinical efficacy of cetirizine for allergic respiratory diseases has been established in numerous trials. There is evidence that cetirizine improves symptoms of urticaria. Concomitant use of cetirizine also decreases the duration and amount of topical anti-inflammatory preparations needed for the treatment of atopic dermatitis. Interestingly, several clinical studies suggest that cetirizine may be useful in the treatment and prevention of mild asthma.
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22.) Efficacy of second-generation antihistamines in patients with allergic rhinitis and comorbid asthma.
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J Asthma. 2011 Nov;48(9):965-73. doi: 10.3109/02770903.2011.616616. Epub 2011 Oct 4.
Bachert C1, Maspero J.
Author information
1
Department of Otorhinolaryngology, University Hospital Ghent, Ghent, Belgium. claus.bachert@ugent.be
Abstract
BACKGROUND AND AIMS:
Allergic rhinitis (AR) and asthma share common mediators, cytokines, and chemokines from mast cells and basophils that are central to the complex cascade of events involved in the inflammatory response. Histamine is the salient mediator released after immunologic challenge, initiating multiple pathologic processes of the allergic reaction that result in bronchial smooth muscle contraction, vasodilation, mucus hypersecretion, and edema. The recent identification of a fourth histamine receptor has reinforced clinical interest in the pleiotropic effects of histamine and the relative roles of histamine receptors in mediating immune and inflammatory responses.
MATERIAL AND METHODS:
A comprehensive literature search was conducted for the following terms, alone or in combination: allergic rhinitis, asthma, antihistamines, histamine, and histamine receptors, and for the second-generation antihistamines azelastine, cetirizine, desloratadine, ebastine, fexofenadine, levocetirizine, loratadine, mizolastine, and rupatadine. Clinical trials were included that reported results for patients with AR and comorbid asthma who were treated with second-generation antihistamines. The search dates ranged from 1995 through 2010. Clinical studies that were not placebo controlled or double blinded were excluded from this review.
RESULTS:
A total of 14 clinical trials of second-generation nonsedating antihistamines were included in this review.
CONCLUSION:
H1-antihistamines have been shown to attenuate the symptoms associated with early- and late-phase allergic reactions. Cumulative clinical evidence indicates that H1-antihistamines may have a beneficial effect on asthma symptoms and improve quality of life. Scientific significance. Mechanistic and clinical data suggest that the potential of H1-antihistamines to alleviate comorbid asthma symptoms in AR patients should be further investigated.
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23.) Second-generation antihistamines in asthma therapy: is there a protective effect?
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Am J Respir Med. 2002;1(1):27-34.
Walsh GM1.
Author information
1
Department of Medicine & Therapeutics, University of Aberdeen Medical School, IMS Building, Foresterhill, Aberdeen AB25 2ZD, Scotland, UK. g.m.walsh@abdn.ac.uk
Abstract
Second-generation histamine H(1) receptor antagonists are recognized as being highly effective treatments for allergic-based disease and are among the most frequently prescribed drugs in the world. The newer antihistamines represent a heterogeneous group of compounds with markedly different chemical structures, a spectrum of antihistaminic properties, adverse effects, half-life, tissue distribution, metabolism and varying degrees of anti-inflammatory effects. Histamine is an important mast cell- and basophil-derived mediator that has been implicated in the pathogenesis of asthma, resulting in smooth muscle contraction, mucus hypersecretion, and increased vascular permeability leading to mucosal edema. Antihistamines should never be used as monotherapy for asthma but there is evidence that these drugs give a measure of protection in histamine-induced bronchoconstriction. Furthermore, several studies have demonstrated that the use of second-generation antihistamines, as adjunct therapy, may benefit those patients whose allergic asthma co-exists with allergic rhinitis. Indeed, many patients present with both allergic rhinitis and asthma. The link between the upper and lower respiratory airways is now well established and there is increasing evidence that allergic rhinitis is a risk factor for the development of asthma. More recently, a number of novel antihistamines have been developed which are either metabolites of active drugs or enantiomers and there is emerging evidence that at least one of these drugs, desloratadine, may give significant symptomatic benefit in some types of asthma. It is of interest to note that cetirizine provides a primary pharmacological intervention strategy to prevent the development of asthma in specifically-sensitized high risk groups of infants. Moreover, the documented anti-inflammatory activities of antihistamines may provide a novel mechanism of action for the therapeutic control of virus-induced asthma exacerbations by inhibiting the expression of intercellular adhesion molecule-1 (ICAM-1) by airway epithelial cells. Finally, several well-conducted studies suggest that combination therapy with antihistamines and antileukotrienes may be as effective as corticosteroid use in patients with allergic asthma and seasonal allergic rhinitis.
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24.) Drug induced oromandibular dystonia: a case related to prolonged use of cetirizine.
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Parkinsonism Relat Disord. 2014 May;20(5):566-7. doi: 10.1016/j.parkreldis.2014.02.005.
Epub 2014 Feb 18.
Pellecchia MT1, Esposito M2, Cozzolino A3, Squillante M3, Penza P4, Barone P5.
Author information
1
Center for Neurodegenerative Diseases, Department of Medicine and Surgery, University of Salerno, Salerno, Italy. Electronic address: mpellecchia@unisa.it.
2
Department of Neurological Sciences, Federico II University, Naples, Italy.
3
Department of Neurosciences, AOU San Giovanni di Dio e Ruggi d'Aragona, Salerno, Italy.
4
Department of Neurology, "Salvatore Maugeri" Foundation IRCCS-Medical Center of Telese, Italy.
5
Center for Neurodegenerative Diseases, Department of Medicine and Surgery, University of Salerno, Salerno, Italy.
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25.) Loratadine versus cetirizine: assessment of somnolence and motivation during the workday.
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Clin Ther. 2000 May;22(5):573-82.
Salmun LM1, Gates D, Scharf M, Greiding L, Ramon F, Heithoff K.
Author information
1
Schering-Plough Corporation, Kenilworth, New Jersey 07033, USA.
Abstract
OBJECTIVE:
This parallel-group, double-blind study compared the somnolence and motivation profiles of 2 second-generation antihistamines, loratadine and cetirizine, in patients with allergic rhinitis.
BACKGROUND:
Second-generation antihistamines were developed to provide symptomatic relief from allergic disorders without the unwanted side effects of first-generation antihistamines, including somnolence. Recent research has indicated that not all second-generation antihistamines are comparable with respect to somnolence and other cognitive processes.
METHODS:
Patients aged > or = 12 years and actively exhibiting symptoms of allergic rhinitis were randomized to 2 treatment groups to receive 10 mg loratadine or 10 mg cetirizine daily at 8:00 AM for 1 week. After patients took the medication, their somnolence and degree of motivation to perform activities were recorded in an electronic diary using a visual analog scale 4 times during the workday (8:00 AM, 10:00 AM, noon, and 3:00 PM).
RESULTS:
Sixty patients (31 men, 29 women) were randomized to treatment. Somnolence scores were similar for both groups at baseline and at the time of dosing (8:00 AM). However, there was a statistically significant difference in somnolence scores between the loratadine and cetirizine groups at 10:00 AM (P = 0.008), noon (P = 0.001), and 3:00 PM (P < 0.001), with the cetirizine group showing a greater degree of somnolence. The scores on motivation to perform activities were similar for both groups at the baseline and 8:00-AM measurements. In parallel with the somnolence scores, there were statistically significant differences in motivation scores between the loratadine and cetirizine groups at 10:00 AM (P = 0.014), noon (P = 0.001), and 3:00 PM (P < 0.001), indicating that patients taking loratadine were relatively more motivated during the workday.
CONCLUSION:
The results of this study demonstrate that in patients aged > or = 12 years who had allergic rhinitis, cetirizine use promoted somnolence and decreased motivation to perform activities during the workday compared with loratadine.
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26.) Maculopapular and urticarial eruption from cetirizine.
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Contact Dermatitis. 1997 Nov;37(5):249-50.
Stingeni L1, Caraffini S, Agostinelli D, Ricci F, Lisi P.
Author information
1
Department of Medical and Surgical Specialities, University of Perugia, Italy.
REFERENCIAS BIBLIOGRAFICAS / BIBLIOGRAPHICAL REFERENCES
============================================================================
1.) CETIRIZINE, FDA SUMMARY REPORT
2.) Recurrent acute hepatitis associated with use of cetirizine.
3.) Severe hepatitis in a primary sclerosing cholangitis patient receiving recent cetirizine therapy.
4.) Cetirizine-induce cholestasis.
5.) Cetirizine-induced acute generalized exanthematous pustulosis: a serious reaction to a commonly used drug.
6.) Fixed drug eruption to cetirizine with positive lesional patch tests to the three piperazine derivatives.
7.) [Torsades de pointes caused by cetirizine overdose].
8.) Oculogyric crisis in patients taking cetirizine.
9.) Cetirizine-induced dystonic movements.
10.) Involuntary movements associated with cetirizine use.
11.) Multiple fixed drug eruptions due to cetirizine.
12.) Urticaria to cetirizine.
13.) Cetirizine-associated delusions and depression in an 18-year-old woman.
14.) Cetirizine-induced urticaria masquerading as multiple drug intolerance syndrome.
15.) Acute interstitial nephritis secondary to long-term use of cetirizine for the treatment of urticaria pigmentosa.
16.) Cetirizine side effects
18.) Toxic effects of the antihistamine cetirizine in mussel Mytilus galloprovincialis.
19.) Model-predicted occurrence of multiple pharmaceuticals in Swedish surface waters and their flushing to the Baltic Sea.
20.) Development of novel elastic vesicle-based topical formulation of cetirizine dihydrochloride for treatment of atopic dermatitis.
21.) Review of cetirizine hydrochloride for the treatment of allergic disorders.
22.) Efficacy of second-generation antihistamines in patients with allergic rhinitis and comorbid asthma.
23.) Second-generation antihistamines in asthma therapy: is there a protective effect?
24.) Drug induced oromandibular dystonia: a case related to prolonged use of cetirizine.
25.) Loratadine versus cetirizine: assessment of somnolence and motivation during the workday.
26.) Maculopapular and urticarial eruption from cetirizine.
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1.) CETIRIZINE, FDA SUMMARY REPORT
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Source: The FDA
Cetirizine is an active metabolite of hydroxyzine, a currently marketed prescription antihistamine. In clinical trials cetirizine has been associated with somnolence at a rate slightly greater than that seen with placebo (13.7% in adults, 4.2% in children at a dose of 10 mg.
There are two approved formulations of cetirizine:
NDA 19-835: Cetirizine 5 mg (Zyrtec) tablets, approved December, 1995.
NDA 20-346: Cetirizine 1 mg/1 mL (Zyrtec Syrup), approved September, 1996.
Cetirizine tablets are currently labeled for use in adults and children age 12 years and above at a
dose of 5 to 10 mg once daily. Cetirizine Syrup is approved for use in children down to age 2 years. Approved dosing for children age 6 to 11 years is 5 to 10 mg once daily and for children age 2 to 5 years is 2.5 mg (2.5 ml Zyrtec Syrup) once daily.
The NDA reviews for these cetirizne formulations showed that at the labeled dose of 10 mg once daily, the most commonly reported events from placebo-controlled clinical trials included
somnolence (13.7% for cetirizine vs. 6.3% for placebo), fatigue (5.9% vs. 2.6%), and dry mouth
(5.0% vs. 2.3%). The frequency of reported psychiatric disorders after administration of cetirizine was twice that of placebo (18% compared to 9%) in placebo-controlled studies in adults. There was no gender difference.
A total of four clinical pharmacology studies were conducted prior to approval to ascertain the
potential effect of cetirizine on cardiac repolarization, specifically QTc. There was no evidence of QTc prolongation in three of these studies at doses up to six times the labeled dose of 10 mg for up to 7 days. A fourth study showed a 9.1 msec increase in QTc with cetirizine (ketoconazole alone showed an increase of 8.3 msec in the same study, the co-administration of the two was associated with a QTc of 17.4 msec). The validity of this finding has been questioned due to the absence of a known PK interaction between cetirizine and ketonconazole, the absence of preclinical data demonstrating an impact of cetirizine on QTc, and concerns about the reproducibility of this finding. There was no evidence of ECG changes supportive of a QTc effect in either the adult or the pediatric phase 3 controlled clinical trials conducted for product approval.
Additional drug-drug interaction studies have disclosed no significant impact of coadministration of ketoconazole or the macrolide antibiotics erythromycin or azithromycin on cetirizine levels. Other safety information from the approved package insert of potential relevance in an OTC setting include recommendations for dosing adjustment in patients with renal failure and hepatic insufficiency, and in geriatric patients (each because of reduced clearance of cetirizine in that patient population).
As of March, 2001, the AERS database contained a total of 3096 adverse event reports in association with products containing cetirizine. The most prevalent event categories were "drug ineffective" and adverse event terms encoding psychiatric events. Specifically, 39.3% of adverse reaction reports (n = 1216) for cetirizine included one or more nervous system or psychiatric terms. These included sedation (306), headache (107), insomnia (98), syncope (54), agitation (49), nervousness (48), convulsions (44), confusion (41), anxiety (40), paresthesia (38), tremor (38), abnormal dreams (37), depersonalization (34), malaise (34), depression (32), hyperkinetic syndrome (27), abnormal thinking (26), loss of consciousness (25), and hallucinations (23). There were 16 deaths, four of which were possibly attributable to a primary nervous system or psychiatric event. One patient committed suicide when he became confused, depressed and had hallucinations after taking cetirizine.
Among the serious events, three categories were identified as potential areas of concern: convulsions/seizures, ventricular arrhythmias, and thrombocytopenia. As of April 2000, there were 16 reports of new onset seizures temporally related to cetirizine administration. In 11 other cases, there was exacerbation of seizures after initiating treatment with cetirizine. Data are incomplete, but there was a positive dechallenge in 13 patients and a positive rechallenge in 4 patients, suggestive of causality.
As of April 2000, there were 27 cases of ventricular arrhythmias, sudden cardiac death and QT
prolongation temporally associated with cetirizine administration. About 50% if the patients had pre-existing cardiac disease or were taking a concomitant medication that could prolong the QT interval. Four patients were taking a medication that could induce an arrhythmia in a patient with pre-existing QT prolongation. Torsades de pointes was reported in 3 patients and ventricular tachycardia in 6 patients. Asymptomatic prolongation of the QT interval was noted in 4 patients and symptomatic prolongation in 6 patients. There were 5 fatalities in this group. The majority of these patients were adult women. In four patients, the event occurred the same day that treatment with cetirizine was initiated. Based on a careful review of these cases by FDA it appears that a causal relationship may be present between cetirizine and cardiac arrhythmias, however, the data are by no means conclusive.
There were 11 cases of thrombocytopenia possibly associated with cetirizine. Seven cases were
domestic and four were non-US. Seven of these cases were reported solely as thrombocytopenia, the remainder as ITP, TTP, or pancytopenia. The lowest platelet count reported was 1000, with three of the four cases reporting nadir levels less than 10,000. The outcomes include one death and seven patients that were hospitalized. Cetirizine and hydroxyzine have known cross-reactivity with the piperazines, and thrombocytopenia associated with piperazines has been reported in the literature. Based on a careful review of these data by FDA staff it appears that there may be a causal relationship between cetirizne and rare reports of thrombocytopenia; however,the data are not conclusive.
The published literature did not provide additional insight regarding the primary areas of safety
concern.
In conclusion, an extensive review of adverse event reports associated with use of cetirizine revealed possible associations between cetirizine and sedation, neuropsychiactric events, including seizures, cardiac arrhthmias, and thrombocytopenia There is a preponderance of neuropsychiatric adverse events, particularly sedation, which may exceed the rate of reporting of similar events for loratadine and fexofenadine The data are inconclusive with regard to a causal relationship between cetirizine and arrhythmias and thromobcytopenia
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2.) Recurrent acute hepatitis associated with use of cetirizine.
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Ann Pharmacother. 2004 Nov;38(11):1844-7. Epub 2004 Sep 21.
Pompili M1, Basso M, Grieco A, Vecchio FM, Gasbarrini G, Rapaccini GL.
Author information
1
Department of Internal Medicine, Università Cattolica del Sacro Cuore, Rome, Italy. mpompilii@rm.unicatt.it
Abstract
OBJECTIVE:
To describe a case of recurrent acute hepatitis related to the use of cetirizine, a selective histamine(1)-receptor antagonist approved for the treatment of common allergic diseases.
CASE SUMMARY:
A 26-year-old man was hospitalized with a week-long history of weakness, nausea, anorexia, and hyperchromic urine, which had developed after 6 days of therapy with oral cetirizine 10 mg/day for allergic rhinitis. Admission laboratory testing revealed evidence of acute hepatitis and seropositivity for liver-kidney microsome antibodies. Liver biopsy findings of diffuse portal tract and lobular inflammation with a prominent eosinophilic infiltrate were consistent with drug-related hepatitis. The patient was discharged after one week of treatment with tocopherol and glutathione. Three months after discharge, transaminase levels were normal. At 6 months, seropositivity for liver-kidney microsome antibodies was still present, but considerably less intense. The patient had suffered 2 previous episodes of "acute hepatitis of unknown origin," and both had occurred after cetirizine use.
DISCUSSION:
Use of the Naranjo probability scale indicated cetirizine as the probable cause of acute hepatitis, and the positivity for liver-kidney microsome antibodies is suggestive of an autoimmune mechanism for liver damage. As of September 13, 2004, ours is the fourth reported case of acute hepatitis associated with cetirizine and the second in which liver-kidney microsome antibodies have been documented.
CONCLUSIONS:
Although cetirizine is considered to have low potential for severe hepatic toxicity, the possibility that it can provoke autoimmune-mediated hepatotoxicity should be considered.
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3.) Severe hepatitis in a primary sclerosing cholangitis patient receiving recent cetirizine therapy.
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Jurawan R, Smith A.
N Z Med J. 2010 Feb 19;123(1309):106-7.
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4.) Cetirizine-induce cholestasis.
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J Clin Gastroenterol. 2000 Oct;31(3):250-3.
Fong DG1, Angulo P, Burgart LJ, Lindor KD.
Author information
1
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota 55905, USA.
Abstract
Cetirizine, a human metabolite of hydroxyzine, is a selective H1-receptor antagonist currently approved for the treatment of seasonal allergic rhinitis, perennial allergic rhinitis, and chronic urticaria. In U.S. clinical trials, transient reversible hepatic transaminase elevations were observed in <2% of patients during cetirizine therapy. We report a case of cetirizine-induced cholestasis in a 28-year-old man with no previous hepatobiliary disease after a 2-year period of taking cetirizine on a daily basis. The treatment of this patient included the use of ursodeoxycholic acid, as well as hydroxyzine, for symptomatic relief of pruritus. In light of the patient's clinical and biochemical improvement while using hydroxyzine, it appears that the hepatic metabolism of hydroxyzine to metabolites, including cetirizine, is not involved in the pathogenesis of this particular case of drug-induced hepatotoxicity. Cetirizine should be considered as a potential cause of drug-induced cholestasis.
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5.) Cetirizine-induced acute generalized exanthematous pustulosis: a serious reaction to a commonly used drug.
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Dermatol Online J. 2014 May 16;20(5):22613.
Badawi AH, Tefft K, Fraga GR, Liu DY1.
Author information
1
University of Kansas Medical Center.
Abstract
Acute generalized exanthematous pustulosis (AGEP) is an abrupt cutaneous adverse reaction usually in response to medications. It is generally a self-limiting disease if diagnosed promptly and the offending agent discontinued. Cetirizine, a commonly used anti-histamine medication for the treatment of allergic diseases has few reported side effects and is normally well-tolerated and effective. Herein, the first reported case of cetirizine induced AGEP is presented, followed by a discussion of the clinical and pathological aspects of this adverse cutaneous reaction to a widely used drug. Awareness of this reaction is vital owing to the extensive use of cetirizine and the importance of drug cessation once the reaction is identified. Lastly, other pustular cutaneous reactions may present similarly and therefore accurate identification of this disease can prevent unnecessary diagnostic testing.
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6.) Fixed drug eruption to cetirizine with positive lesional patch tests to the three piperazine derivatives.
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Int J Dermatol. 2007 Jul;46(7):760-2.
Cravo M1, Gonçalo M, Figueiredo A.
Author information
1
Clinic of Dermatology, University Hospital, Coimbra, Portugal. mariana.cravo@netcabo.pt
Abstract
BACKGROUND:
The H1-antihistamine cetirizine, a piperazine derivative widely used in daily practice, is rarely the cause of cutaneous drug reaction. Nevertheless, four cases of fixed drug eruption (FDE) as a result of this drug have been described recently. We present the case of a 45-year-old woman with a multilocalized FDE following oral intake of cetirizine for allergic rhinitis.
METHODS:
Patch testing with hydroxyzine 1% and 10% in petrolatum (Chemotechnique), and with powdered Zyrtec (cetirizine) and Xyzal (levocetirizine) pills, prepared at 20% in water and at 20% in petrolatum, was performed in both residual lesions and healthy skin.
RESULTS:
Positive results (++) to these drugs (24 h occlusion and readings at days 2 and 3) were obtained in residual lesions only. These results allowed us to confirm the drug responsible for this FDE and to study cross-reactions between antihistamines of the same chemical family.
CONCLUSIONS:
To the best of our knowledge, this is the first report of FDE to cetirizine with positive patch testing to hydroxyzine, cetirizine, and levocetirizine. This case highlights the importance of patch testing in the study of cutaneous drug reactions, namely FDE.
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7.) [Torsades de pointes caused by cetirizine overdose].
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Arch Mal Coeur Vaiss. 2005 Feb;98(2):157-61.
[Article in French]
Renard S1, Ostorero M, Yvorra S, Zerrouk Z, Bargas E, Bertocchio P, Pracchia S, Ebagosti A.
Author information
1
Département de Pathologies Cardiovasculaires, Centre Hospitalier Général de Martigues. renardsebastien@9online.fr
Abstract
Several therapeutic substances can cause torsades de pointes, especially if they prolong the QT interval and/or if there is an associated hypokalaemia. Certain second generation H1 antihistamines have been incriminated in the occurrence of such ventricular arrhythmias, such as terfenadine and astezimole, which have been withdrawn. Cetirizine, widely used in the treatment of allergic reactions, is a second generation H1 antihistamine with as yet no precautions of use regarding rhythm disturbances. No documented case of arrhythmia attributable to this drug has been reported. We report the case of a dialysed patient with chronic renal failure who had symptomatic episodes of torsades de pointes in the context of hypokalaemia and cetirizine overdose. In the light of this observation it would appear that the prescription of cetirizine is contra-indicated under such conditions.
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8.) Oculogyric crisis in patients taking cetirizine.
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Am J Ophthalmol. 2004 Feb;137(2):355-7.
Fraunfelder FW1, Fraunfelder FT.
Author information
1
Casey Eye Institute, Oregon Health and Science University, Portland, Oregon 97201, USA. eyedrug@ohsu.edu
Abstract
PURPOSE:
To report oculogyric crisis in patients receiving cetirizine and inform clinicians on the characteristics of this drug-induced ocular side effect.
METHODS:
For this retrospective, observational case series, case reports were collected from the National Registry of Drug-Induced Ocular Side Effects (Casey Eye Institute, Portland, Oregon). The World Health Organization Causality Assessment Guide of Suspected Adverse Reactions was used to categorize the cases.
RESULTS:
Nine cases were reported, with eight occurring in the pediatric age group. Dosage ranged from 5 to 10 mg orally and onset of symptoms ranged from 3 to 184 days. Six cases of oculogyric crisis had positive rechallenge data. Eight cases had complete neurologic consultation including radiographic studies.
CONCLUSIONS:
Cetirizine can cause oculogyric crisis, especially in the pediatric age group. Extensive neurologic workups may be avoided if clinicians recognize this drug-induced ocular side effect.
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9.) Cetirizine-induced dystonic movements.
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Neurology. 2006 Jan 10;66(1):143-4.
Rajput A1, Baerg K.
Author information
1
Division of Neurology, University of Saskatchewan, Saskatoon, SK S7N 0W8, Canada. rajputa@sask.usask.ca
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10.) Involuntary movements associated with cetirizine use.
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Am J Psychiatry. 2011 Aug;168(8):855. doi: 10.1176/appi.ajp.2011.11040534.
Romo CA, Joshi KG, Waters BM.
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11.) Multiple fixed drug eruptions due to cetirizine.
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Br J Dermatol. 2002 Nov;147(5):1025-6.
Inamadar AC, Palit A, Athanikar SB, Sampagavi VV, Deshmukh NS.
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12.) Urticaria to cetirizine.
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J Investig Allergol Clin Immunol. 2002;12(2):136-7.
Tella R1, Gaig P, Bartra J, Garcia-Ortega P.
Author information
1
Allergy Unit, Hospital Universitari Joan XXIII, Tarragona, Spain.
Abstract
A patient with recurrent idiopathic urticaria reported exacerbations after treatment with cetirizine. Prick test to cetirizine was negative. Double-blind challenge tests with mizolastine, loratadine, fexofenadine, dexchlorpheniramine, ebastine, ketotifen, and placebo were negative, whereas hydroxyzine and its active metabolite, cetirizine, reproduced the urticaria. Identification of uncommon adverse reactions to H1 antihistamines is important, particularly because they may mimic the underlying disease.
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13.) Cetirizine-associated delusions and depression in an 18-year-old woman.
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Clin Neuropharmacol. 2013 May-Jun;36(3):96-7. doi: 10.1097/WNF.0b013e318290b9b2.
Garden BC1, Francois D.
Author information
1
Weill Cornell Medical College, New York Presbyterian Hospital, White Plains, NY, USA.
Abstract
INTRODUCTION:
Cetirizine is a second-generation H1 histamine receptor antagonist that is commonly used for symptomatic relief of hay fever and other allergies and can be combined with pseudoephedrine hydrochloride, a decongestant. The most common adverse effects include headache, nausea, nasopharyngitis, vomiting, and coughing.
OBJECTIVE:
To report on an adolescent 18-year-old woman who developed delusional thinking and depression after starting treatment with cetirizine.
CASE REPORT:
We report on an adolescent 18-year-old woman who developed delusional thinking and depression after starting treatment with cetirizine. Once cetirizine was discontinued, the patient returned to her clinical baseline.
CONCLUSIONS:
Physicians need to be aware of the potential psychiatric adverse effects associated with cetirizine.
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14.) Cetirizine-induced urticaria masquerading as multiple drug intolerance syndrome.
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Indian J Dermatol Venereol Leprol. 2015 Sep-Oct;81(5):537-9. doi: 10.4103/0378-6323.162338.
Singh S, Kumar P, Sharma VK1.
Author information
1
Department of Dermatology and Venereology, All India Institute of Medical Sciences, New Delhi, India.
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15.) Acute interstitial nephritis secondary to long-term use of cetirizine for the treatment of urticaria pigmentosa.
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Clin Exp Dermatol. 2013 Jan;38(1):100-1. doi: 10.1111/j.1365-2230.2012.04471.x. Epub 2012 Oct 22.
Raghavendran R, Shipman AR, Langman G, Vijayan S, Orpin SD.
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16.) Cetirizine side effects
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Source: Fda
The following events were observed infrequently (less than 2%), in either 3982 adults and
children 12 years and older or in 659 pediatric patients aged 6 to 11 years who received ZYRTEC
in U.S. trials, including an open adult study of six months duration. A causal relationship of these
infrequent events with ZYRTEC administration has not been established.
Autonomic Nervous System:
anorexia, flushing, increased salivation, urinary retention.
Cardiovascular:
cardiac failure, hypertension, palpitation, tachycardia.
Central and Peripheral Nervous Systems:
abnormal coordination, ataxia, confusion, dysphonia, hyperesthesia, hyperkinesia, hypertonia, hypoesthesia, leg cramps, migraine, myelitis,paralysis, paresthesia, ptosis, syncope, tremor, twitching, vertigo, visual field defect.
Gastrointestinal:
abnormal hepatic function, aggravated tooth caries, constipation, dyspepsia,
eructation, flatulence, gastritis, hemorrhoids, increased appetite, melena, rectal hemorrhage,
stomatitis including ulcerative stomatitis, tongue discoloration, tongue edema.
Genitourinary:
cystitis, dysuria, hematuria, micturition frequency, polyuria, urinary
incontinence, urinary tract infection.
Hearing and Vestibular:
deafness, earache, ototoxicity, tinnitus.
Metabolic/Nutritional: dehydration, diabetes mellitus, thirst.
Musculoskeletal:
arthralgia, arthritis, arthrosis, muscle weakness, myalgia.
Psychiatric:
abnormal thinking, agitation, amnesia, anxiety, decreased libido, depersonalization,
depression, emotional lability, euphoria, impaired concentration, insomnia, nervousness,
paroniria, sleep disorder.
Respiratory System:
bronchitis, dyspnea, hyperventilation, increased sputum, pneumonia,
respiratory disorder, rhinitis, sinusitis, upper respiratory tract infection.
Reproductive: dysmenorrhea, female breast pain, intermenstrual bleeding, leukorrhea,
menorrhagia, vaginitis.
Reticuloendothelial:
lymphadenopathy.
Skin:
acne, alopecia, angioedema, bullous eruption, dermatitis, dry skin, eczema, erythematous
rash, furunculosis, hyperkeratosis, hypertrichosis, increased sweating, maculopapular rash,
photosensitivity reaction, photosensitivity toxic reaction, pruritus, purpura, rash, seborrhea, skin
disorder, skin nodule, urticaria.
Special Senses:
parosmia, taste loss, taste perversion.
Vision:
blindness, conjunctivitis, eye pain, glaucoma, loss of accommodation, ocular
hemorrhage, xerophthalmia.
Body as a Whole:
accidental injury, asthenia, back pain, chest pain, enlarged abdomen, face
edema, fever, generalized edema, hot flashes, increased weight, leg edema, malaise, nasal polyp, pain, pallor, periorbital edema, peripheral edema, rigors.
Occasional instances of transient, reversible hepatic transaminase elevations have occurred
during cetirizine therapy. Hepatitis with significant transaminase elevation and elevated bilirubin
in association with the use of ZYRTEC has been reported.
In foreign marketing experience the following additional rare, but potentially severe adverse
events have been reported: anaphylaxis, cholestasis, glomerulonephritis, hemolytic anemia,
hepatitis, orofacial dyskinesia, severe hypotension, stillbirth, and thrombocytopenia.
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17.) Unbearable Pruritus After Withdrawal of (Levo)cetirizine
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Drug Saf Case Rep. 2016 Dec; 3: 16.
Published online 2016 Nov 26. doi: 10.1007/s40800-016-0041-9
Corine Ekhart,corresponding author Petra van der Horst, and Florence van Hunsel
Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH ’s Hertogenbosch, The Netherlands
Corine Ekhart, Phone: 0031-73-6469700, Email: ln.beral@trahke.c.
Abstract
Twelve cases of unbearable pruritus several days after withdrawal of (levo)cetirizine were reported to the Netherlands Pharmacovigilance Centre Lareb. Eleven reports concerned women and one report concerned a man, aged 19–58 years. These patients had been using these antihistamines continuously for months or years. They had tried to stop using antihistamines on several occasions but felt unable to withdraw the drug because of the unbearable maddening itch. Finally, slowly tapering the drug or using a short course of corticosteroids helped to withdraw (levo)cetirizine. The Naranjo assessment score ranged from two to four for all the cases, indicating a possible relationship.
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18.) Toxic effects of the antihistamine cetirizine in mussel Mytilus galloprovincialis.
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Teixeira M1, Almeida Â2, Calisto V1, Esteves VI1, Schneider RJ3, Wrona FJ4, Soares AM2, Figueira E2, Freitas R5.
Author information
1
Department of Chemistry & CESAM, University of Aveiro, 3810-193 Aveiro, Portugal.
2
Department of Biology & CESAM, University of Aveiro, 3810-193 Aveiro, Portugal.
3
BAM Federal Institute for Materials Research and Testing, Richard-Willstaetter-Str. 11, Berlin, Germany.
4
Department of Geography, University of Victoria, National Water Research Institute, STN CSC, Victoria, BC, Canada.
5
Department of Biology & CESAM, University of Aveiro, 3810-193 Aveiro, Portugal. Electronic address: rosafreitas@ua.pt.
Abstract
Recent studies have become increasingly focused on the assessment of pharmaceuticals occurrence in aquatic ecosystems, however the potential toxicity to non-target organisms is still largely unknown. The antihistamine cetirizine is a commonly used pharmaceutical, already detected in surface waters of marine aquatic systems worldwide. In the present study Mytilus galloprovincialis mussels were exposed to a range of cetirizine concentrations (0.3, 3.0, 6.0 and 12.0 μg/L), resembling moderate to highly contaminated areas, over 28 days. The responses of different biochemical markers were evaluated in mussels whole soft tissue, and included energy-related parameters (glycogen content, GLY; protein content, PROT; electron transport system activity, ETS), and oxidative stress markers (superoxide dismutase activity, SOD; catalase activity, CAT; glutathione S-transferases activity, GSTs; lipid peroxidation levels, LPO; reduced (GSH) and oxidized (GSSG) glutathione content). The results obtained demonstrated that with the increase of exposure concentrations mussels tended to increase their energy reserves and maintain their metabolic potential, which was significantly higher only at the highest concentration. Our findings clearly revealed that cetirizine inhibited the activity of GSTs and although induced the activity of antioxidant enzymes (SOD and CAT) mussels were not able to prevent cellular damages observed through the increase of LPO associated to the increase of exposure concentrations. Thus, this study confirmed that cetirizine induces toxic effects in Mytilus galloprovincialis, which, considering their trophic relevance, wide use as bioindicator and wide spatial distribution of this species, can result in ecological and economic negative impacts at a large scale.
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19.) Model-predicted occurrence of multiple pharmaceuticals in Swedish surface waters and their flushing to the Baltic Sea.
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Environ Pollut. 2017 Apr;223:595-604. doi: 10.1016/j.envpol.2017.01.062. Epub 2017 Jan 30.
Lindim C1, van Gils J2, Cousins IT3, Kühne R4, Georgieva D5, Kutsarova S6, Mekenyan O7.
Author information
1
ACES - Department of Environmental Science and Analytical Chemistry, Stockholm University, SE 10691, Stockholm, Sweden. Electronic address: claudia.lindim@aces.su.se.
2
Deltares, PO Box 177, 2600 MH Delft, The Netherlands. Electronic address: jos.vanGils@deltares.nl.
3
ACES - Department of Environmental Science and Analytical Chemistry, Stockholm University, SE 10691, Stockholm, Sweden. Electronic address: ian.cousins@aces.su.se.
4
Department of Ecological Chemistry, Helmholtz Centre for Environmental Research-UFZ, 04318 Leipzig, Germany. Electronic address: ralph.kuehne@ufz.de.
5
Laboratory of Mathematical Chemistry, University "Prof. As. Zlatarov", 8010 Bourgas, Bulgaria. Electronic address: denitsa_georgieva@btu.bg.
6
Laboratory of Mathematical Chemistry, University "Prof. As. Zlatarov", 8010 Bourgas, Bulgaria. Electronic address: stela_kutsarova@btu.bg.
7
Laboratory of Mathematical Chemistry, University "Prof. As. Zlatarov", 8010 Bourgas, Bulgaria. Electronic address: omekenya@btu.bg.
Abstract
An exposure assessment for multiple pharmaceuticals in Swedish surface waters was made using the STREAM-EU model. Results indicate that Metformin (27 ton/y), Paracetamol (6.9 ton/y) and Ibuprofen (2.33 ton/y) were the drugs with higher amounts reaching the Baltic Sea in 2011. 35 of the studied substances had more than 1 kg/y of predicted flush to the sea. Exposure potential given by the ratio amount of the drug exported to the sea/amount emitted to the environment was higher than 50% for 7 drugs (Piperacillin, Lorazepam, Metformin, Hydroxycarbamide, Hydrochlorothiazide, Furosemide and Cetirizine), implying that a high proportion of them will reach the sea, and below 10% for 27 drugs, implying high catchment attenuation. Exposure potentials were found to be dependent of persistency and hydrophobicity of the drugs. Chemicals with Log D > 2 had exposure potentials <10% regardless of their persistence. Chemicals with Log D < -2 had exposure potentials >35% with higher ratios typically achieved for longer half-lives. For Stockholm urban area, 17 of the 54 pharmaceuticals studied had calculated concentrations higher than 10 ng/L. Model agreement with monitored values had an r2 = 0.62 for predicted concentrations and an r2 = 0.95 for predicted disposed amounts to sea.
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20.) Development of novel elastic vesicle-based topical formulation of cetirizine dihydrochloride for treatment of atopic dermatitis.
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AAPS PharmSciTech. 2013 Dec;14(4):1284-93.
Goindi S, Kumar G, Kumar N, Kaur A.
Abstract
Cetirizine is a piperazine-derived second-generation antihistaminic drug recommended for treatment of pruritus associated with atopic dermatitis. The present investigation encompasses development of a nanosized novel elastic vesicle-based topical formulation of cetirizine dihydrochloride using combination of Phospholipon® 90G and edge activators with an aim to have targeted peripheral H1 antihistaminic activity. The formulation was optimized with respect to phospholipid/drug/charge inducer ratio along with type and concentration of edge activator. The optimized formulation was found to be satisfactory with respect to stability, drug content, entrapment efficiency, pH, viscosity, vesicular size, spreadability, and morphological characteristics. The ex vivo permeation studies through mice skin were performed using Franz diffusion cell assembly. It was found that the mean cumulative percentage amount permeated in 8 h was almost twice (60.001 ± 0.332) as compared to conventional cream (33.268 ± 0.795) and aqueous solution of drug (32.616 ± 0.969), suggesting better penetration and permeation of cetirizine from the novel vesicular delivery system. Further, therapeutic efficacy of optimized formulation was assessed against oxazolone-induced atopic dermatitis in mice. It was observed that the developed formulation was highly efficacious in reducing the itching score (4.75 itches per 20 min) compared to conventional cream (9.75 itches per 20 min) with profound reduction in dermal eosinophil count and erythema score. To conclude, a novel vesicular, dermally safe, and nontoxic topical formulation of cetirizine was successfully developed and may be used to treat atopic dermatitis after clinical investigation.
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21.) Review of cetirizine hydrochloride for the treatment of allergic disorders.
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Expert Opin Pharmacother. 2004 Jan;5(1):125-35.
Portnoy JM1, Dinakar C.
Author information
1
Children's Mercy Hospital, 2401 Gillham Road, Kansas City, MO 64108, USA. jportnoy@cmh.edu
Abstract
Cetirizine hydrochloride is an orally-active and selective histamine (H(1))-receptor antagonist. It is a second-generation antihistamine and a human metabolite of hydroxyzine. Therefore, its principal effects are mediated via selective inhibition of peripheral H(1) receptors. The antihistaminic activity of cetirizine has been documented in a variety of animal and human models. In vivo and ex vivo animal models have shown negligible anticholinergic and antiserotonergic activity. In clinical studies, however, dry mouth has been seen more commonly with cetirizine than with placebo. In vitro receptor binding studies have shown no measurable affinity for receptors other than H(1) receptors. Auto-radiographical studies with radiolabelled cetirizine in the rat have shown negligible penetration into the brain. Ex vivo experiments in the mouse have shown that systemically administered cetirizine does not significantly occupy cerebral H(1) receptors. Impairment of CNS function is comparable to other low-sedating antihistamines at the recommended dose of 10 mg/day for adults. It has anti-inflammatory properties that may play a role in asthma management. It does not interact with concomitantly administered medications, it has no cardiac adverse effects, and it does not appear to be associated with teratogenicity. Cetirizine is predominantly eliminated by the kidneys with a mean elimination half-life is 8.3 h. It is rapidly absorbed, and significant clinical inhibition of a wheal and flare response occurs in infants, children and adults within 20 min of a single oral dose and persists for 24 h. No tolerance to the wheal and flare response occurs even after 1 month of daily treatment. The clinical efficacy of cetirizine for allergic respiratory diseases has been established in numerous trials. There is evidence that cetirizine improves symptoms of urticaria. Concomitant use of cetirizine also decreases the duration and amount of topical anti-inflammatory preparations needed for the treatment of atopic dermatitis. Interestingly, several clinical studies suggest that cetirizine may be useful in the treatment and prevention of mild asthma.
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22.) Efficacy of second-generation antihistamines in patients with allergic rhinitis and comorbid asthma.
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J Asthma. 2011 Nov;48(9):965-73. doi: 10.3109/02770903.2011.616616. Epub 2011 Oct 4.
Bachert C1, Maspero J.
Author information
1
Department of Otorhinolaryngology, University Hospital Ghent, Ghent, Belgium. claus.bachert@ugent.be
Abstract
BACKGROUND AND AIMS:
Allergic rhinitis (AR) and asthma share common mediators, cytokines, and chemokines from mast cells and basophils that are central to the complex cascade of events involved in the inflammatory response. Histamine is the salient mediator released after immunologic challenge, initiating multiple pathologic processes of the allergic reaction that result in bronchial smooth muscle contraction, vasodilation, mucus hypersecretion, and edema. The recent identification of a fourth histamine receptor has reinforced clinical interest in the pleiotropic effects of histamine and the relative roles of histamine receptors in mediating immune and inflammatory responses.
MATERIAL AND METHODS:
A comprehensive literature search was conducted for the following terms, alone or in combination: allergic rhinitis, asthma, antihistamines, histamine, and histamine receptors, and for the second-generation antihistamines azelastine, cetirizine, desloratadine, ebastine, fexofenadine, levocetirizine, loratadine, mizolastine, and rupatadine. Clinical trials were included that reported results for patients with AR and comorbid asthma who were treated with second-generation antihistamines. The search dates ranged from 1995 through 2010. Clinical studies that were not placebo controlled or double blinded were excluded from this review.
RESULTS:
A total of 14 clinical trials of second-generation nonsedating antihistamines were included in this review.
CONCLUSION:
H1-antihistamines have been shown to attenuate the symptoms associated with early- and late-phase allergic reactions. Cumulative clinical evidence indicates that H1-antihistamines may have a beneficial effect on asthma symptoms and improve quality of life. Scientific significance. Mechanistic and clinical data suggest that the potential of H1-antihistamines to alleviate comorbid asthma symptoms in AR patients should be further investigated.
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23.) Second-generation antihistamines in asthma therapy: is there a protective effect?
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Am J Respir Med. 2002;1(1):27-34.
Walsh GM1.
Author information
1
Department of Medicine & Therapeutics, University of Aberdeen Medical School, IMS Building, Foresterhill, Aberdeen AB25 2ZD, Scotland, UK. g.m.walsh@abdn.ac.uk
Abstract
Second-generation histamine H(1) receptor antagonists are recognized as being highly effective treatments for allergic-based disease and are among the most frequently prescribed drugs in the world. The newer antihistamines represent a heterogeneous group of compounds with markedly different chemical structures, a spectrum of antihistaminic properties, adverse effects, half-life, tissue distribution, metabolism and varying degrees of anti-inflammatory effects. Histamine is an important mast cell- and basophil-derived mediator that has been implicated in the pathogenesis of asthma, resulting in smooth muscle contraction, mucus hypersecretion, and increased vascular permeability leading to mucosal edema. Antihistamines should never be used as monotherapy for asthma but there is evidence that these drugs give a measure of protection in histamine-induced bronchoconstriction. Furthermore, several studies have demonstrated that the use of second-generation antihistamines, as adjunct therapy, may benefit those patients whose allergic asthma co-exists with allergic rhinitis. Indeed, many patients present with both allergic rhinitis and asthma. The link between the upper and lower respiratory airways is now well established and there is increasing evidence that allergic rhinitis is a risk factor for the development of asthma. More recently, a number of novel antihistamines have been developed which are either metabolites of active drugs or enantiomers and there is emerging evidence that at least one of these drugs, desloratadine, may give significant symptomatic benefit in some types of asthma. It is of interest to note that cetirizine provides a primary pharmacological intervention strategy to prevent the development of asthma in specifically-sensitized high risk groups of infants. Moreover, the documented anti-inflammatory activities of antihistamines may provide a novel mechanism of action for the therapeutic control of virus-induced asthma exacerbations by inhibiting the expression of intercellular adhesion molecule-1 (ICAM-1) by airway epithelial cells. Finally, several well-conducted studies suggest that combination therapy with antihistamines and antileukotrienes may be as effective as corticosteroid use in patients with allergic asthma and seasonal allergic rhinitis.
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24.) Drug induced oromandibular dystonia: a case related to prolonged use of cetirizine.
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Parkinsonism Relat Disord. 2014 May;20(5):566-7. doi: 10.1016/j.parkreldis.2014.02.005.
Epub 2014 Feb 18.
Pellecchia MT1, Esposito M2, Cozzolino A3, Squillante M3, Penza P4, Barone P5.
Author information
1
Center for Neurodegenerative Diseases, Department of Medicine and Surgery, University of Salerno, Salerno, Italy. Electronic address: mpellecchia@unisa.it.
2
Department of Neurological Sciences, Federico II University, Naples, Italy.
3
Department of Neurosciences, AOU San Giovanni di Dio e Ruggi d'Aragona, Salerno, Italy.
4
Department of Neurology, "Salvatore Maugeri" Foundation IRCCS-Medical Center of Telese, Italy.
5
Center for Neurodegenerative Diseases, Department of Medicine and Surgery, University of Salerno, Salerno, Italy.
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25.) Loratadine versus cetirizine: assessment of somnolence and motivation during the workday.
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Clin Ther. 2000 May;22(5):573-82.
Salmun LM1, Gates D, Scharf M, Greiding L, Ramon F, Heithoff K.
Author information
1
Schering-Plough Corporation, Kenilworth, New Jersey 07033, USA.
Abstract
OBJECTIVE:
This parallel-group, double-blind study compared the somnolence and motivation profiles of 2 second-generation antihistamines, loratadine and cetirizine, in patients with allergic rhinitis.
BACKGROUND:
Second-generation antihistamines were developed to provide symptomatic relief from allergic disorders without the unwanted side effects of first-generation antihistamines, including somnolence. Recent research has indicated that not all second-generation antihistamines are comparable with respect to somnolence and other cognitive processes.
METHODS:
Patients aged > or = 12 years and actively exhibiting symptoms of allergic rhinitis were randomized to 2 treatment groups to receive 10 mg loratadine or 10 mg cetirizine daily at 8:00 AM for 1 week. After patients took the medication, their somnolence and degree of motivation to perform activities were recorded in an electronic diary using a visual analog scale 4 times during the workday (8:00 AM, 10:00 AM, noon, and 3:00 PM).
RESULTS:
Sixty patients (31 men, 29 women) were randomized to treatment. Somnolence scores were similar for both groups at baseline and at the time of dosing (8:00 AM). However, there was a statistically significant difference in somnolence scores between the loratadine and cetirizine groups at 10:00 AM (P = 0.008), noon (P = 0.001), and 3:00 PM (P < 0.001), with the cetirizine group showing a greater degree of somnolence. The scores on motivation to perform activities were similar for both groups at the baseline and 8:00-AM measurements. In parallel with the somnolence scores, there were statistically significant differences in motivation scores between the loratadine and cetirizine groups at 10:00 AM (P = 0.014), noon (P = 0.001), and 3:00 PM (P < 0.001), indicating that patients taking loratadine were relatively more motivated during the workday.
CONCLUSION:
The results of this study demonstrate that in patients aged > or = 12 years who had allergic rhinitis, cetirizine use promoted somnolence and decreased motivation to perform activities during the workday compared with loratadine.
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26.) Maculopapular and urticarial eruption from cetirizine.
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Contact Dermatitis. 1997 Nov;37(5):249-50.
Stingeni L1, Caraffini S, Agostinelli D, Ricci F, Lisi P.
Author information
1
Department of Medical and Surgical Specialities, University of Perugia, Italy.
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