ELIDEL (Pimecrolimus) y PROTOPIC (Tacrolimus) EFECTOS SECUNDARIOS !!!
ELIDEL (Pimecrolimus) and PROTOPIC (Tacrolimus) ADVERSE EFFECTS !!!
PUBLICADO 2007 ACTUALIZADO 2023
EDITORIAL ESPANOL
=================
Las Cremas Elidel (Pimecrolimus) y Protopic (tacrolimus) fueron lanzadas al mercado para tratar el eczema y dermatitis Atópica, aprobadas por la FDA en el año 2.000 y 2001.
Creo nadie pensó que iban a estar asociadas a riesgo de contraer cáncer.
Esta perla es del año 2.005 en que se hicieron los primeros
reportes, el mismo año en que el Dermagic cancelo sus publicaciones.
A
petición de numerosos pacientes el Dermagic esta de regreso y una vez mas
con estas 7 referencias, queda demostrado apocalipticamente y
contundentemente lo que esta ocurriendo con estas cremas y la excelencia
del Dermagic.
....La FDA ha recibido los informes de 78 casos de cáncer, incluso piel y linfoma, en pacientes tratados con Elidel o Protopic.....
Estas cremas nacieron como grandes promesas y adelantos en el tratamiento de la dermatitis atópica, pero el tiempo se encargo de demostrar que su uso prolongado puede inducir la aparición de varios tipos de cáncer
"Elidel (pimecrolimus) y Protopic (tacrolimus) son medicamentos inmunosupresores que se utilizan para tratar ciertas afecciones de la piel. Debido a su acción inmunosupresora, estos medicamentos pueden favorecer el desarrollo de tumores si se absorben en cantidades suficientes a través de la piel y si el tratamiento se mantiene durante tiempos prolongados."
Saludos.
Dr. José Lapenta
EDITORIAL ENGLISH
================
The Creams Elidel (Pimecrolimus) and Protopic (tacrolimus) they were thrown to the market to treat the eczema and Atopic dermatitis, approved by the FDA in the year 2.000 and 2001
I believe nobody thought that they will be associated to risk of
contracting cancer. This pearl is from the year 2.005 when that the first
reports were made, the same year that the Dermagic cancels their
publications.
At the request of numerous patients the Dermagic
is BACK and once, with these 7 references, it is demonstrated
apocalyptically and overwhelmingly what is this happening with these
creams and the excellence of the Dermagic.
......the FDA has received reports of 78 cases of cancers, including skin and lymphoma, in patients treated with both Elidel or Protopic.....
These creams were born as great promises and advances in the treatment of atopic dermatitis, but time took care of demonstrating that their prolonged use can induce the appearance of various types of cancer.
"Elidel (pimecrolimus) and Protopic (tacrolimus) are immunosuppressive drugs used to treat certain skin conditions. Due to their immunosuppressive action, these drugs may promote tumor development if sufficient amounts are absorbed through the skin and if the treatment is maintained for long periods of time."
Dr. Jose Lapenta R.
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REFERENCIAS BIBLIOGRAFICAS / BIBLIOGRAPHICAL REFERENCES
====================================================
1.) Protopic
and Elidel may cause cancer
====================================================
2.) Protopic Causing Cancer
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3.) PROTOPIC, side effects
====================================================
4.)
Alert for Healthcare Professionals Pimecrolimus (marketed as Elidel)
=====================================================
5.)
Injured by Elidel?
=====================================================
6.)
Pimecrolimus tópico (Elidel) Español/Spanish
===================================================
7.) Cancer warning over eczema creams (Elidel and Protopic)
=====================================================
=================================================
1.) Protopic and Elidel may cause cancer
====================================================
Source: Http://www.news.medical-net.
Protopic and Elidel may cause cancer
Pharmaceutical News
Published:
Sunday, 13-Mar-2005
Protopic and Elidel, two treatments
for eczema approved in 2000 and 2001, have now been found to cause cancer
in three different animal species.
The Food and Drug Administration
(FDA) has advised health care professionals to prescribe Elidel
(pimecrominum) and Protopic (tacrolimus) only as directed and only after
other eczema treatments have failed to work because this potential cancer
risk associated with their use. It is also adding a black box warning to
the health professional label for the products and developing a Medication
Guide for patients.
The actions follow the recommendations made
by the FDA's Pediatric Advisory Committee during its meeting last month
(Feb 2005). Cancer was found in animal species and data showed that the
risk of cancer increased as the amount of the drug given increased.
The
data also included a small number of reports of cancers in children and
adults treated with Elidel or Protopic.The manufacturers of the products
will conduct research to determine whether there is an actual risk of
cancer in humans, and, if so, its extent. Both products are applied to the
skin to control eczema, but do so by suppressing the immune system.
FDA's
Public Health Advisory specifically advises physicians to weigh the risks
and benefits of these drugs in adults and children and consider the
following:
Elidel and Protopic are approved for short-term and
intermittent treatment of atopic dermatitis (eczema) in patients
unresponsive to, or intolerant of other treatments.
Elidel and
Protopic are not approved for use in children younger than 2 years old.
The long-term effect of Elidel and Protopic on the developing immune
system in infants and children is not known. In clinical trials, infants
and children younger than 2 years of age treated with Elidel had a higher
rate of upper respiratory infections than those treated with placebo
cream.
Elidel and Protopic should be used only for short periods of
time, not continuously. The long term safety of these products is
unknown.
Children and adults with a weakened or compromised immune
system should not use Elidel or Protopic.
Use the minimum amount of
Elidel and Protopic needed to control the patient's symptoms. The animal
data suggest that the risk of cancer increases with increased exposure to
Elidel or Protopic.
http://www.fda.gov
==================================================
2.) Protopic Causing Cancer
===================================================
Source: http://www.onlinelawyersource.com/
The FDA’s public health advisory announcement about Protopic causing
cancer came in March 2005 after researchers discovered that patients using
this prescription ointment are at an increased risk of developing lymph
node and skin cancer. As a result of Protopic causing cancer, the FDA has
warned doctors and patients of these risks and advised them to only use
Protopic when alternative treatments have failed or cannot be
tolerated.
Protopic is a topical tacrolimus ointment that was
first approved by the FDA in 2000. This prescription medication is used to
treat patients older than two years of age who have moderate to severe
atopic dermatitis, a form of eczema. There are two strengths of Protopic
though only one is approved for pediatric use. Patients who must take this
medication should use it on a short term basis and no longer than
necessary in light of protopic causing cancer.
In addition to
concerns about protopic causing cancer, there are certain patient
populations for whom Protopic use is contraindicated. Women who are
pregnant or breastfeeding should not use Protopic. Patients whose atopic
dermatitis is infected should also not use this product. Patients with
Netherton’s syndrome, a genetic condition marked by significant skin
irritation, should also not use this topical ointment.
Information
about protopic causing cancer was collected from animal studies, human
case studies, and scientific knowledge about how this medication works. In
animal studies, researchers found that those treated with protopic
developed lymph node and skin cancer tumors at a faster rate than those
not given protopic. Human case studies show protopic causing cancer in
human subjects as well. The FDA has stated that it will take at least ten
years of human clinical trials to determine the extent of protopic causing
cancer risks.
In addition to protopic causing cancer, use of
this prescription medication also carries other risks. Patients using
protopic may experience common skin irritations including stinging,
burning, itching, redness and soreness, headaches, and influenza-like
symptoms. Protopic users are at an increased risk of developing some viral
infections including chicken pox and shingles. Exposure to sunlight or
tanning beds can also increase the chances of protopic causing cancer.
If
you or a loved one has used protopic tacrolimus ointment, you may wish to
speak with your health care professional about the risks of protopic
causing cancer. Patients should only use this product exactly as directed
by a doctor for the shortest duration of treatment possible. A doctor will
inform you of the way to use the ointment in order to mitigate the risk of
protopic causing cancer.
If you or a loved one has developed
cancer while using protopic ointment, you may wish to explore your legal
rights and options with regards to seeking compensation for your losses. A
highly trained and experienced attorney can help to protect and maximize
your legal interests in a case involving protopic causing cancer.
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3.) PROTOPIC, side effects
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Source: Http://www.medicalmalpractice.com/
1.) What is Protopic?
2.) What is eczema?
3.) Side Effects
4.)
2005 FDA Warning over Protopic Cancer
5.) 2006 Protopic Cancer BLACK
BOX WARNING
6.) Injured by Protopic?
On January 19, 2006,
the FDA announced the approval of a BLACK BOX WARNING for Protopic
Ointment to warn of the serious risk of cancer posed by this topical
prescription medication. Evidence shows that Protopic increases the risk
of skin cancer and lymphomas. If you or a loved one has developed cancer
or other serious side effects while using Protopic, please contact us at
Oshman & Mirisola to learn more about your legal rights and options.
You may be eligible to receive compensation for your losses and
suffering.
1.) What is Protopic?
The FDA approved
Protopic (tacrolimus ointment) in 2000. This topical ointment is used to
treat moderate to severe atopic dermatitis, also known as eczema. Protopic
is not intended for use in children under the age of two. Astellas Pharma,
Inc. (formerly known as Fujisawa Healthcare) manufactures Protopic
ointment. Due to known Protopic side effects, this medication should only
be used for a short period of time. Protopic is not intended for long-term
use.
Experts also warn that Protopic should only be used as a
“second-line” treatment when other medications have not successfully
treated a patient’s eczema. Protopic may also be recommended when other
medications have caused significant side effects. Nonetheless, Protopic
should only be prescribed as a last resort treatment of eczema.
2.)
What is eczema?
Eczema, or atopic dermatitis, is one of the
most common skin conditions experienced by infants and young children.
Experts estimate that 10 to 15 percent of all children suffer from eczema.
In the majority of cases, eczema is resolved by the time these children
enter their teens. However, for some patients, treatments are necessary to
treat eczema.
Eczema is characterized by chronically itchy,
dry, red, and scaly skin. Because patients often have an overwhelming urge
to scratch at infected areas, significant skin damage can result. Although
the exact cause of eczema is unknown, many experts believe there is an
allergic or immune component to the condition.
Protopic, and a
similar drug called Elidel (marketed by Novartis AG), are approved to
treat eczema. While the exact function of these topical drugs are not well
understood, it is thought that Protopic and Elidel have various effects on
the immune system.
3.) Protopic Side Effect Risks
Serious
Protopic side effects can include:
VIRAL INFECTIONS
Protopic can increase the risk of getting shingles, chicken pox, or other
viral infections.
SKIN IRRITATION While Protopic is intended to
relieve symptoms of skin irritation, this drug can also aggravate skin
problems. Protopic side effects can include stinging, soreness, a burning
sensation, or itchy skin.
FLU-LIKE SYMPTOMS Protopic can cause a
patient to develop symptoms of the flu and headaches. This may be due to
the drug’s effects on the immune system.
SKIN CANCER AND LYMPHOMA
Protopic cancer is a serious risk associated with this medication.
4.) 2005 FDA Warning over Protopic Cancer
In March 2005, the
FDA issued an advisory warning to inform consumers about the rare but
serious risk of Protopic cancer. Based on information from animal studies,
human case studies, and knowledge of the drug’s function, Protopic appears
to increase the risk of developing skin cancer and lymph node cancer
(lymphoma).
Studies also show that skin tumors developed faster
in subjects, treated with Protopic, who have been exposed to light.
Therefore, patients undergoing light therapy for their skin condition,
other forms of phototherapy, or those with a lot of exposure to the sun,
may be at an increased risk for Protopic cancer.
When the FDA
advisory warning was issued, the FDA stated that it might take ten or more
years to determine if Protopic is undeniably linked to cancer. They
announced that further studies would be conducted to learn more about the
serious risks of Protopic cancer.
5.) 2006 Protopic Cancer
BLACK BOX WARNING
In January 2006, the FDA announced that a
black box warning, the strictest warning short of a recall, would be added
to Protopic labeling to warn of the serious risks of cancer. The agency
also issued a Medication Guide to help ensure that patients are aware of
the serious risks of Protopic cancer.
The Protopic black box
warning also reiterates that Protopic should only be used as a second-line
treatment in patients who have not received relief from other medications
who do not have any risk factors for Protopic side effects. Protopic’s
maker and the FDA state they will continue to evaluate Protopic safety to
determine the exact causation between this drug and various forms of
cancer.
6.) Injured by Protopic?
If you or a loved
one has suffered serious Protopic side effects, please contact us to speak
with a qualified attorney at Oshman & Mirisola about your legal rights
and options. We are experienced in handling cases of a similar nature and
are prepared to protect and maximize your legal interests. You may be
eligible to seek compensation for your losses and suffering.
Contact
Us
====================================================
4.) Alert for
Healthcare Professionals Pimecrolimus (marketed as Elidel)
=====================================================
Source: http://www.fda.gov/cder/drug/InfoSheets/HCP/elidelHCP.htm
FDA ALERT [3/2005]:
The FDA has issued a public health
advisory to inform healthcare professionals and patients about a potential
cancer risk from use of Elidel (pimecrolimus). This concern is based on
information from animal studies, case reports in a small number of
patients, and knowledge of how drugs in this class work. It may take human
studies of ten years or longer to determine if use of Elidel is linked to
cancer. In the meantime, this risk is uncertain, and FDA advises Elidel
should be used only as labeled, for patients after other prescription
treatments have failed to work or cannot be tolerated.
This
information reflects FDA’s preliminary analysis of data concerning this
drug. FDA is considering, but has not reached a final conclusion about,
this information. FDA intends to update this sheet when additional
information or analyses become available.
--------------------------------------------------------------------------------
To
report any unexpected adverse or serious events associated with the use of
Elidel, please contact the FDA MedWatch program at 1-800-FDA-1088
or http://www.fda.gov/medwatch/report/hcp.htm
Recommendations
Physicians with patients using Elidel, or who
are considering prescribing the drug, should consider the following:
Use
Elidel only as second-line agent for short-term and intermittent treatment
of atopic dermatitis, a form of eczema, in patients unresponsive to, or
intolerant of other treatments.
Avoid use of Elidel in children
younger than 2 years of age. The effect of Elidel on the developing immune
system in infants and children is not known. In clinical studies, infants
and children younger than 2 years old treated with Elidel had a higher
rate of upper respiratory infections than those treated with placebo
cream.
Use Elidel only for short periods of time, not
continuously. The long term safety of Elidel is unknown.
Children
and adults with a weakened or compromised immune system should not use
Elidel.
Use the minimum amount of Elidel needed to control the
patient’s symptoms. In animals, increasing the dose resulted in higher
rates of cancer.
Data Summary
Although pimecrolimus
is not genotoxic and does not interact directly with DNA, it may have a
potential to impair local immunosurveillance. Repeat dose studies
conducted with topical application of pimecrolimus in mice demonstrated a
dose and treatment dependent development of lymphoma. Carcinogenicity
studies conducted with oral administration of pimecrolimus in mice
demonstrated a dose dependent development of lymphoma and benign thymoma.
Carcinogenicity studies conducted with topical administration of
pimecrolimus in rats demonstrated development of follicular cell adenoma
of the thyroid. Data from a recently conducted oral nine-month monkey
study showed a dose-related increase in virus-associated lymphoma
following administration of pimecrolimus.
As of December 2004,
the FDA had received 10 cases of postmarketing reports linking Elidel with
cancer-related adverse events. Four cases occurred in children, 3 of these
in children less than 6 years of age. The other 6 cases occurred in
adults.
Of the 10 postmarketing cases reporting cancer, 6
described cutaneous tumors, 1 described a lymph node/cutaneous tumor
related event, and the locations of 3 others were unreported. Four cases
described lymphomas; 5 cases described a variety of tumors, including
basal cell carcinoma and squamous cell carcinoma; and 1 case described
granulomatous lymphadenitis. The median time until diagnosis after
initiation of treatment with Elidel was 90 days, with a range between 1
week and 300 days. Two cases also reported a lymphadenopathy. Two cases
were confounded, 1 with the presence of nodules prior to the diagnosis of
basal cell carcinoma; and another with a pre-existing condition associated
with an increased risk for malignant transformation.
Elidel is
sometimes absorbed through the skin, though usually at very low amounts.
Occasionally, children who have been treated with Elidel have had
measurable blood levels of the drug. The potential for systemic
immunosuppression is unknown and the role of Elidel in the development of
the cancer-related events in the individual postmarketing cases is also
uncertain.
FDA Patient Information Sheet
http://www.fda.gov/cder/drug/InfoSheets/patient/ElidelPIS.pdf
Questions? Call Drug Information, 1-888-INFO-FDA (automated) or
301-827-4570
druginfo@fda.hhs.gov
Date created:
February 14, 2005, updated June 15, 2006
===================================================
5.) Injured by Elidel?
====================================================
Source: http://www.yourlawyer.com/topics/overview/elidel
Elidel, manufactured by Novartis, was approved by the FDA in December
2001. Elidel is prescribed to treat Eczema and is also commonly prescribed
off-label for psoriasis and dermatitis seborrhea.
On March 10,
2005, the FDA stated that Elidel should carry a strong advisory about
cancer risks. Research shows that the cream is absorbed into the body and
may have the potential to cause cancer. The FDA is working on a ″black
box″ warning for Elidel. The data collected by the FDA showed that the
risk of cancer increased as the amount of the drug given increased. This
data also included a small number of reports of cancers in children and
adults treated with Elidel. Elidel and similar medications suppress the
immune system, which may be a precipitating factor in the development of
cancer. Elidel has become widely prescribed as an alternative to steroid
creams, which also have long-term side effects.
On January 20,
2005, the FDA declared that Elidel must bear "black box" warnings of
possible cancer risks. The new labeling will also recommend that the drug
be prescribed for use only after other prescription topical medicines have
been tried by patients. The FDA is also issuing a guide updating patients
of its concerns. A black box warning is the most serious type of warning
in prescription drug labeling. The warning will be located lower on the
labels of the two drugs than is typical, although a statement higher on
the labels will refer to the risk. As of October, the FDA has received
reports of 78 cases of cancers, including skin and lymphoma, in patients
treated with both Elidel or Protopic, said Dr. Stanka Kukich, the acting
director of the FDA's dermatologic and dental drug products division.
If
you or a loved one took Elidel and suffered side effects, please fill out
the form at the right for a free case evaluation by a qualified drug side
effects attorney.
Elidel
FDA Orders 'Black Box' Warning
for Eczema Drugs, Elidel and ProtopicJan 21, 2006 | www.Newsinferno.com
In
an important notification, the Federal Drug Administration (FDA) has
announced the approval of updated labeling for two topical eczema
drugs,...
More »
FDA to Require Warnings on 2 Eczema
DrugsJan 20, 2006 | AP
The labels on two prescription creams to
treat eczema will have to bear "black box" warnings of possible cancer
risks.The Food and Drug...
More »
Health Alert for Eczema
PatientsMay 3, 2005 | www.cfcn.ca
Health Canada and the U-S
Food and Drug Administration have issued health alerts on two Eczema skin
creams.But Canadian dermatologists say the...
FDA Panel Urges
Warnings on 2 Eczema DrugsFeb 16, 2005 | Washington Post
A
prescription cream and an ointment that millions of Americans use to
control eczema should carry strong warnings to alert consumers that the
drugs...
More »
FDA Considers Warnings for Eczema
CreamsFeb 12, 2005 | Washington Post
Government scientists, concerned
that two prescription creams used widely for a common skin condition may
increase the risk of certain cancers,...
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6.)
Pimecrolimus tópico (Elidel)
===================================================
Source: http://www.nlm.nih.gov/medlineplus/spanish/druginfo/medmaster/a603027-es.html
¿Para cuáles condiciones o enfermedades se prescribe este medicamento?
El
pimecrolimus se usa para controlar los síntomas de la dermatitis atópica
(una enfermedad que afecta la piel también llamada eccema). Pimecrolimus
sólo se usa para tratar a aquellos pacientes que no pueden tomar otros
medicamentos para tratar la dermatitis atópica, o cuyos síntomas no han
sido controlados por otros medicamentos. Pimecrolimus pertenece a una
clase de medicamentos llamados inmunodepresores. Funciona al prevenir la
activación de ciertas células que causan prurito (picazón) y
enrojecimiento de la piel.
¿Cómo se debe usar este
medicamento?
Pimecrolimus viene envasado en forma de crema para
aplicar sobre la piel. Se aplica, por lo general, 2 veces al día durante 6
semanas cada vez. Siga cuidadosamente las instrucciones en la etiqueta del
medicamento y pregúntele a su doctor o farmacéutico cualquier cosa que no
entienda. Use el medicamento exactamente como se indica. No use más ni
menos que la dosis indicada ni tampoco más seguido que lo prescrito por su
doctor.
Usted no debe usar la crema pimecrolimus en forma
regular durante mucho tiempo. Sólo debe aplicarla cuando tenga síntomas de
dermatitis atópica. Llame a su doctor cuando los síntomas desaparezcan
para determinar si usted debe dejar de usar el medicamento. También llame
a su doctor tan pronto como note que los síntomas han regresado para
determinar si usted debe comenzar a usar pimecrolimus nuevamente.
Puede
tomar 2 semanas o más antes de que usted sienta el beneficio total de este
medicamento, pero los síntomas deberían desaparecer dentro de 6 semanas.
Llame a su doctor si los síntomas empeoran en cualquier momento durante el
tratamiento o si no mejoran después de haber usado el medicamento por 6
semanas.
Para usar la crema, siga estos pasos:
Lávese
las manos con agua y jabón.
Aplique una capa delgada de crema a todas
las zonas afectadas de la piel. Usted puede aplicar pimecrolimus a todas
las superficies afectadas de la piel incluyendo la cabeza, cara y cuello.
Evite el contacto del medicamento con los ojos y la boca.
Frote
suavemente la crema sobre la piel.
Lávese las manos con agua y jabón
para remover los residuos del medicamento. No se lave las manos si están
siendo tratadas con pimecrolimus.
Usted puede cubrir las áreas que
están siendo tratadas con ropa, pero no use vendas, apósitos ni envuelva
el área.
Asegúrese de no lavar la crema de las áreas afectadas. No
nade, no se duche ni se bañe inmediatamente después de aplicar la
crema.
¿Qué otro uso se le da a este medicamento?
Este
medicamento también puede ser prescrito para otros usos; pídale más
información a su doctor o farmacéutico.
¿Cuáles son las
precauciones especiales que debo seguir?
Antes de comenzar a usar
pimecrolimus:
dígale a su doctor y a su farmacéutico si usted
es alérgico al pimecrolimus o a otros medicamentos.
dígale a su
doctor y a su farmacéutico qué medicamentos con y sin prescripción está
tomando, como por ejemplo vitaminas, suplementos nutricionales y productos
fabricados a base de hierbas. Asegúrese de mencionar los siguientes:
antifúngicos como fluconazol (Diflucan), itraconazol (Sporanox) y
ketoconazol (Nizoral); bloqueadores de los canales de calcio como
diltiazem (Cardizem, Dilacor, Tiazac, otros), y verapamilo (Calan,
Isoptin, Verelan); cimetidina (Tagamet); claritromicina (Biaxin);
ciclosporina (Neoral, Sandimmune); danazol (Danocrine); delavirdina
(Rescriptor); eritromicina (E.E.S., E-Mycin, Erythrocin); fluoxetina
(Prozac, Sarafem); fluvoxamina (Luvox); inhibidores de la proteasa del VIH
como indinavir (Crixivan), y ritonavir (Norvir); isoniazida (INH,
Nydrazid); metronidazol (Flagyl); nefazodona (Serzone); anticonceptivos
orales (píldoras anticonceptivas); otros ungüentos, cremas o lociones;
troleandomicina (TAO); y zafirlukast (Accolate). Su doctor podría cambiar
la dosis de su medicamento o vigilarle cuidadosamente para detectar la
aparición de efectos secundarios.
dígale a su doctor si usted tiene o
alguna vez ha tenido enfermedades que afectan el sistema inmunitario como
cáncer, síndrome de inmunodeficiencia adquirida (SIDA), o síndrome severo
combinado de inmunodeficiencia; síndrome de Netherton (un tipo de
enfermedad que afecta la piel), o cualquier tipo de infección a la piel,
especialmente varicela, culebrilla, herpes o eccema herpeticum. También
dígale a su doctor si usted está siendo tratado con cualquier forma de
terapia liviana como fototerapia, UVA o UVB.
dígale a su doctor si
está embarazada, tiene planes de quedar embarazada o si está amamantando.
Si queda embarazada mientras usa este medicamento, llame a su doctor de
inmediato.
evite la exposición innecesaria o prolongada a la luz
solar y use ropa que cubra su piel, gafas de sol y filtro solar. También
evite la exposición a la luz solar artificial como lámparas de sol y camas
de bronceado. La crema de pimecrolimus puede aumentar el riesgo de que
usted contraiga cáncer de piel si su piel está expuesta a la luz solar.
evite
la exposición a la varicela, herpes y otros tipos de virus. Si usted está
expuesto a una de estas enfermedades mientras usa pimecrolimus, llame a su
doctor de inmediato.
usted debe saber que el cuidado de la piel y los
humectantes pueden ayudar a aliviar los síntomas provocados por esta
condición. Pregúntele a su doctor qué crema humectante debe usar y
aplíquela siempre después de usar pimecrolimus.
¿Qué dieta especial
debo seguir mientras tomo este medicamento?
Converse con su doctor
sobre el consumo de jugo de toronjas (pomelos) mientras usa este
medicamento.
¿Qué tengo que hacer si me olvido de tomar una
dosis?
Aplique la dosis que olvidó tan pronto como lo recuerde, sin
embargo, si es hora para la siguiente, sáltese aquella que no aplicó y
siga con la dosificación regular. No aplique una dosis doble para
compensar la que olvidó.
¿Cuáles son los efectos secundarios
que podría provocar este medicamento?
Pimecrolimus puede provocar
efectos secundarios. Dígale a su doctor si cualquiera de estos síntomas se
vuelve severo o si no desaparece:
ardor, o enrojecimiento en
las áreas donde se aplicó el medicamento (llame a su doctor si el
enrojecimiento dura más de 1 semana)
cefalea (dolor de cabeza)
tos
congestión
nasal o rinorrea (secreción nasal), o enrojecimiento de la nariz
Algunos
efectos secundarios podrían provocar graves consecuencias para la salud.
Los siguientes síntomas son poco comunes, pero si experimenta alguno de
ellos, llame a su doctor de inmediato:
dolor o enrojecimiento
en la garganta
fiebre
síntomas similares a los de la gripe
dolor,
supuración y signos de otro tipo de una infección en los oídos
verrugas,
protuberancias o crecimientos de otro tipo en la piel
inflamación en
las glándulas del cuello
Algunos pacientes contrajeron cáncer
de piel o cáncer en los ganglios linfáticos mientras estaban usando la
crema pimecrolimus. No se sabe si la crema pimecrolimus fue la causante
del cáncer que se desarrolló o si los pacientes habrían desarrollado
cáncer aunque no hubieran usado el medicamento. Converse con su doctor
acerca de los riesgos de usar la crema pimecrolimus.
Pimecrolimus
puede provocar otros efectos secundarios. Llame a su doctor si tiene
cualquier problema inusual mientras toma este medicamento.
¿Cómo
debo almacenar este medicamento?
Mantenga este medicamento en su
envase, bien cerrado y fuera del alcance de los niños. Almacénelo a
temperatura ambiente y lejos del calor excesivo y la humedad (no en el
baño). Deseche cualquier medicamento que esté vencido o que ya no se
utilice. Converse con su farmacéutico acerca del desecho adecuado de los
medicamentos.
¿Qué debo hacer en caso de una sobredosis?
Si
alguien ingiere la crema pimecrolimus, llame a la oficina local de control
de envenenamiento al 1-800-222-1222. Si la víctima está inconsciente, o no
respira, llame inmediatamente al 911.
¿Qué otra información de
importancia debería saber?
Cumpla con todas las citas con su
doctor.
No deje que otras personas usen su medicamento.
Pregúntele al farmacéutico cualquier duda que tenga sobre cómo renovar la
prescripción de su medicamento.
Marca(s) comercial(es):
Elidel
===================================================
7.) Cancer warning over eczema creams (Elidel and Protopic)
=====================================================
Source; http://news.bbc.co.uk/1/hi/health/4339317.stm
The Food and Drug Administration said research had shown that Elidel and Protopic may pose a cancer risk when absorbed into the body.
It said babies should not be treated with the creams at all.
The view is strongly disputed by the manufacturers, Novartis, which makes Elidel, and Fujisawa Pharmaceutical, which makes Protopic.
Any patient or parent of a patient who has concerns about their treatment or their child's treatment should speak to their doctor
Medicines and Healthcare products Regulatory Agency
The FDA is working on a "black box" warning for the creams - the strongest warning carried by medicines in the US.
In a statement it said animal studies had shown a potential link with cancer.
There were also reports of seven cases of lymphoma and six of skin cancer among children and adults treated with Elidel or Protopic.
Both creams work by suppressing the immune system. Depressing immune activity in this way is known to potentially contribute to cancer.
Monitoring
A spokesperson for the UK's Medicines and Healthcare products Regulatory Agency said it was closely monitoring the safety of the creams.
These are valuable medications, and if used properly they significantly reduce the debilitating impact of eczema
Dr Clay Cockerell
"Any patient or parent of a patient who has concerns about their treatment or their child's treatment should speak to their doctor."
Margaret Cox, chief executive of the UK's National Eczema Society, told the BBC News website the creams already came with strong warnings about their over-use in this country.
"Because they are new treatments one does have to recognise that the long term effects are uncertain," she said.
"To date we haven't had any evidence of direct causality between topical application of these creams in humans and cancer."
Company defence
Novartis dismissed claims Elidel could increase the risk of cancer, and said it planned no immediate change in its product label.
National Institute for Clinical Excellence guidance
Treatment with tacrolimus (Protopic) or pimecrolimus (Elidel) should be initiated only by physicians with a special interest and experience in dermatology, and only after careful discussion with the patient about the potential risks and benefits of all appropriate second-line treatment options
In a statement it said: "Novartis agrees that patients suffering from mild to moderate eczema need to be informed about the safe and effective use of Elidel, but we believe a recommendation to add a black box warning to the label is unsubstantiated by clinical evidence and experience in more than five million patients worldwide."
Fujisawa Pharmaceutical said it had not found any data to clearly link Protopic to cancer, and believes it has provided sufficient information to ensure the drug is used safely.
The American Academy of Dermatology (AAD) has also questioned the FDA move, arguing that virtually none of the creams would get inside the body.
Dr Clay Cockerell, ADD president, said: "These are valuable medications, and if used properly they significantly reduce the debilitating impact of eczema and allow millions of our patients to live normal lives."
In February, members of an FDA advisory panel said they were concerned the companies were aggressively advertising the medicines to treat infants and others with skin problems that the creams are not approved to treat.
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