DERMAGIC EXPRESS / Dermatologia y Bibliografia - Dermatology & bibliography DERMAGIC EXPRESS / Dermatologia y Bibliografia - Dermatology & bibliography

sábado, 28 de enero de 2017

SCABIES AND GENETICS, ITCHES TO ME AND NOT TO YOU, SOME RELATIONSHIP.? / ESCABIOSIS Y GENETICA PORQUE HAY COMEZON EN ALGUNAS PERSONAS Y OTRAS NO, ALGUNA RELACION ?



Scabies and genetics, itches to me, and not to you, some relationship. ?


Escabiosis y genética, me pica a mi y no a ti, alguna relacion. ? 



EDITORIAL ENGLISH
=================
Hello Friends of the net, today's topic: THE SCABIES AND THE GENETICS, SOME RELATIONSHIP ???. If I tell you that a relationship exists between the vulgar and common
SCABIES and the susceptibility to suffer it I would HAVE to convince you. In some of these bibliographical references it is captured that studies have been made where a susceptibility has been demonstrated statistically significant among the Histocompatibility (HLA) antigens and the SCABIES, and in the two studies the associate antigen was the SAME one. 


In others the immunologic paper of the organism is important factor in the behavior of the illness and its clinical manifestations. At the end a REVIEW of those already therapies well-known lindane, crotamiton, permethrin and the one FASHION and popular IVERMECTIN.
 

Who would have thought that we have a predisposition for that BUG to mount us ???


El parasito de la escabiosis, heces huevos y lesiones genitales



























Lindane was removed from the market for demonstrating high toxicity for both humans and animals and vegetation between years 2001, 2005 and 2009. However there I put a study of the year 2,015 where lindane is compared with permethrin reporting little adverse effects in humans Studied. (28)

One of the causes of the perpetuation of SCABIES over the centuries is that not all sufferers develop symptoms, some cause them a great itcht in the body especially at night, and others do not develop any type of symptomatology, becoming carriers, and if they do not do the treatment they transmit it to other people. The means of contagion usually is a bed, cloth, and intimate contact. The parasite exists since the world is world.

In the photos: the mite (microscopic), the eggs, the shit (caca) and lesions in hands and genitals in a child. In the other photo you can see the tunnels or furrows that make the mites in the skin. A couple, female and male are mounted on the skin and reproduce in the follicles, so with each passing day, the itching increases, as the number of mites increases. Scabies itch a lot at night, because the parasite goes into "activity"...so


Ela parasito de la escabiosis y tuneles en la piel


Without forgetting the adage: "Scabies with taste does not itch...and if itch it does not mortify..." remember that if you do not treat yourself and the whole family and do a good cleaning with warmth of beds and own clothes, including mattress and pillows ... you will not get free from the bug...!

In the 28 references, the facts,,, 


Greetings to ALL, !!
 

Dr. Jose Lapenta .,,, 
Dr, Jose M, Lapenta



EDITORIAL ESPANOL
=================
Hola Amigos de la red, el tema de hoy: LA ESCABIOSIS Y LA GENETICA, ALGUNA RELACION ???. Si yo les dijese que existe una relacion entre la vulgar y común SARNA y la predisposición a padecerla TENDRIA que convencerlos.  


Pues en algunas de estas referencias bibliográficas queda plasmado que se han hecho estudios donde se ha demostrado una susceptibilidad estadísticamente significativa entre los antígenos de histocompatibilidad (HLA) y la ESCABIOSIS, y en los dos estudios el antígeno asociado fue el MISMO. En otras el papel inmunológico del organismo es factor importante en el comportamiento de la enfermedad y sus manifestaciones clínicas. 

Al final un REPASO de las ya terapias conocidas Lindano, Crotamiton, permetrina y el ultimo grito de la MODA el popular IVERMECTIN.
 

Quien iba a pensar que tenemos una predisposición para que ese BICHITO se nos monte ??? 

El Lindano fue sacado del mercado por demostrarse alta toxicidad tanto para el humano como animales y vegetación entre los años 2001, 2005 y 2009. Sin embargo allí les pongo un estudio del año 2.015 donde se compara Lindano con permetrina reportándose escasos efectos adversos en los humanos estudiados.(28)

Una de las causas de la perpetuación de la SARNA a través de los siglos, es que no todos los afectados desarrollan síntomas, a unos les da gran comezón en el cuerpo sobre todo de noche, y otros no desarrollan ningún tipo de sintomatología, convirtiéndose en portadores sanos, y si no hacen el tratamiento lo transmiten a otras personas. El medio de contagio por lo general es una cama, las telas, y contacto intimo. EL parasito existe desde que el mundo es mundo.

En las fotos: el acaro (es microscópico), los huevos, el pupú (caca) y lesiones en manos y genitales en un niño. En la otra se aprecian los túneles o surcos que hacen los ácaros en la epidermis. Se montan en la piel una pareja, hembra y varón y se reproducen en los folículos de la piel, por ello cada día que pasa, la comezón aumenta, al aumentar el numero de ácaros. La sarna pica mucho en las noches, porque el parasito entra en "actividad"... de modo que

Sin dejar de recordar el viejo adagio que dice: "sarna con gusto no pica... y si pica no mortifica"... recuerda que si no te tratas adecuadamente tu y toda la familia y haces una buena limpieza con calor de ropas de camas y propias, incluyendo colchón y almohadas... no te liberaras del parasito ...
En las 28 referencias, los hechos,,,

Saludos a todos !!!

Dr. José Lapenta .,,, 

Dr., José M, Lapenta


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REFERENCIAS BIBLIOGRAFICAS / BIBLIOGRAPHICAL REFERENCES
===================================================================
1.) Histocompatibility (HLA) antigens in Egyptians with two parasitic skin diseases (scabies and leishmaniasis).
2.) The immunology of scabies.
3.) HLA antigens in patients with scabies.
4.) Immunoglobulin and complement deposits in the skin and circulating immune complexes in scabies.
5.) The immunology of scabies.
6.) Serum IgE before and after treatment for scabies.
7.) Cutaneous histiocytosis with Langerhans cell features induced by scabies: a case report.
8.) Skin test and radioallergosorbent test characteristics of scabietic patients.
9.) In vitro demonstration of specific immunological hypersensitivity to scabies mite.
10.) A DNA fingerprinting system for the ectoparasite Sarcoptes scabiei.
11.) The behaviour of Sarcoptes scabiei var. hominis in human skin: an ultrastructural study.
12.) Immunohistopathological status of the skin in cases infested with three species of mites.
13.) Scabietic nodules: a dermatopathologic and immunofluorescent study.
14.) Immunologic cross-reactivity among various strains of Sarcoptes scabiei.
15.) Can house dust mite-triggered atopic dermatitis be alleviated using acaricides?
16.) Epiluminescence microscopy. A new approach to in vivo detection of Sarcoptes scabiei.
17.)[Ivermectin and tropical dermatoses]
18.) Success of a scabies control program in an Australian aboriginal community.
19.) Equivalent therapeutic efficacy and safety of ivermectin and lindane in the treatment of human scabies.
20.) The treatment of scabies with ivermectin.
21.) Epidemiology and control of scabies in an Egyptian village.
22.) Crusted scabies in two immunocompromised children: successful treatment with oral ivermectin.
23.) Treatment of scabies with ivermectin.
24.) Efficacy and tolerance of oral ivermectin in scabies.
25.) Norwegian scabies in a patient with acquired immunodeficiency syndrome.
26.) Ivermectin for Sarcoptes scabiei hyperinfestation.
27.) Crusted scabies of the scalp in dermatomyositis patients: three cases treated with oral ivermectin.
=================================================================
1.) Histocompatibility (HLA) antigens in Egyptians with two parasitic skin
diseases (scabies and leishmaniasis).
=================================================================
J Egypt Soc Parasitol 1990 Dec;20(2):565-72

Morsy TA, Romia SA, al-Ganayni GA, Abu-Zakham AA, al-Shazly AM, Rezk RA
Department of Parasitology, Faculty of Medicine, Ain Shams University, Egypt.

The frequency of human leucocytic antigens (HLA) were studied in 62
patients with scabies and 27 patients with cutaneous leishmaniasis to
evaluate the role of HLA antigens as genetic markers in the pathogenesis of
these parasitic skin diseases. A significant statistical association was
proved between HLA-A11 antigen and scabies and between HLA-A11, -B5 and -B7
antigens and diffuse cutaneous leishmaniasis.

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2.) The immunology of scabies.
=================================================================
Ann Allergy 1983 Dec;51(6):560-6

Dahl MV
Scabies is an inflammatory skin disease caused by the mite Sarcoptes
scabiei. The mite itself provokes little dermatitis. The rash and itch
associated with scabies is probably a manifestation of immune response. The
immune response may help to limit the number of infesting organisms either
directly by toxic products generated during the reaction or indirectly by
evoking scratch. Critical studies using purified antigens from scabies
mites in vivo and in vitro will be necessary in order to clarify the nature
of the antigens involved and the role of different types of immune
responses in producing clinical disease.

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3.) HLA antigens in patients with scabies.
=================================================================
Br J Dermatol 1981 Mar;104(3):317-20

Falk ES, Thorsby E
Sixty patients with scabies were typed for thirty-three antigens of the
HLA-A, -B and -C series. A significantly increased frequency was found for
HLA-AII (28.3%), compared to healthy controls (10.4%). This deviation was
only found in those of the patients without signs of atopic disease.

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4.) Immunoglobulin and complement deposits in the skin and circulating
immune complexes in scabies.
=================================================================
ARTICLE SOURCE: Acta Derm Venereol (Sweden), 1982, 62(1) p73-6
AUTHOR(S): Salo OP; Reunala T; Kalimo K; Rantanen T
PUBLICATION TYPE: JOURNAL ARTICLE
ABSTRACT: Sixteen patients with papulovesicular, 6 with nodular and one
with a Norwegian scabies were studied. Direct immunofluorescence (IF)
examination revealed C3 deposits in the skin lesions of 13 of the 18
patients. Among them were all 6 cases with nodular scabies. C3 was found
mostly in dermal vessel walls and 3 of the patients also showed IgM and 2
IgA deposits at the same site. No circulating immune complexes were found,
with a solid-phase C1q radioimmunoassay (RIA), but HSV- and RSV-RIA methods
detected IgM antibodies of rheumatoid factor type in 5 of the 15 sera
examined. These results suggest that local complement activation and
perhaps also immune complex deposition may by important in the pathogenesis
of the papular and nodular skin lesions of human scabies.

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5.) The immunology of scabies.
=================================================================
ARTICLE SOURCE: Semin Dermatol (United States), Mar 1993, 12(1) p15-21
AUTHOR(S): Cabrera R; Agar A; Dahl MV
AUTHOR'S ADDRESS: Department of Dermatology, University of Chile School of
Medicine, Santiago.
PUBLICATION TYPE: JOURNAL ARTICLE; REVIEW (52 references); REVIEW, TUTORIAL
ABSTRACT: Individuals with scabies react to bites by generating a
cell-mediated immune response at the bite site. This elicits a very itchy
papule that is often excoriated. Sometimes ulcerated papules, vasculitis,
and nodules develop as a result of other immunologic reactions in skin.
Immunologic reactions mediated by antibodies of the immunoglobulin G (IgG),
IgM, and especially, IgE classes may also be involved. None of these
reactions have been shown to eliminate all mites from the skin surface, but
locally these reactions may prevent the epidemic multiplication of scabies'
organisms on the skin surface, as observed in some patients with crusted
scabies.

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6.) Serum IgE before and after treatment for scabies.
=================================================================
ARTICLE SOURCE: Allergy (Denmark), Apr 1981, 36(3) p167-74
AUTHOR(S): Falk ES
PUBLICATION TYPE: JOURNAL ARTICLE
ABSTRACT: In 120 patients, treated for scabies infection, the serum IgE
concentrations fell from high levels in 54 and normal levels in 66 to lower
levels 12 months after treatment. The specific IgE antibodies to
Dermatophagoides pteronyssinus (RAST) were also reduced 12 months after
treatment. The decrease in both IgE concentrations and IgE antibodies was
most conspicuous in non-atopic patients. These findings confirm previous
observations of specific immunological hypersensitivity to scabies mite,
and that scabies infection stimulates the production of IgE antibodies.

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7.) Cutaneous histiocytosis with Langerhans cell features induced by
scabies: a case report.
=================================================================
ARTICLE SOURCE: Pediatr Dermatol (United States), Dec 1994, 11(4) p327-30
AUTHOR(S): Talanin NY; Smith SS; Shelley ED; Moores WB
AUTHOR'S ADDRESS: Division of Dermatology, Medical College of Ohio, Toledo
43699-0008.
INDEXING CHECK TAG(S): Case Report; Human; Male
PUBLICATION TYPE: JOURNAL ARTICLE
ABSTRACT: An infant with biopsy-proven scabies developed nodular lesions.
Histopathology revealed atypical histiocytes with Langerhans cell features.
Within six months after treatment all skin lesions gradually disappeared.
We suggest that the nodules in scabies can be due to Langerhans cell
proliferation.

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8.) Skin test and radioallergosorbent test characteristics of scabietic
patients.
=================================================================
Morgan MS; Arlian LG; Estes SA
Department of Biological Sciences, Wright State University, Dayton, Ohio
45435,
USA.
Am J Trop Med Hyg (UNITED STATES) Aug 1997 57 (2) p190-6 ISSN: 0002-9637
Contract/Grant No.: AI-17252--AI--NIAID
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9711
Subfile: AIM; INDEX MEDICUS
The scabies mite Sarcoptes scabiei and the Dermatophagoides house dust
mites (HDM)
are related phylogenetically and are the sources of several cross-reactive
antigens.
The purpose of this study was to investigate the immune response to S.
scabiei and
HDM in scabietic patients. Skin test sensitivity and serum IgE to both S.
scabiei
and HDM were determined for patients who had or previously had confirmed
ordinary
scabies. A retrospective group included nine subjects who had received
successful
treatment three weeks to one year prior to the study. A prospective group
included
16 subjects with active scabies. Allergic histories were obtained, serum was
collected, and skin prick tests (SPTs) were performed at enrollment for all
and
periodically over the next 12 months for the prospective patients. None of
the
individuals in either group reported a known sensitivity to HDM. Six of
the nine
retrospective patients were SPT positive to both S. scabiei and HDM and two
of these
showed circulating IgE specific for these antigens. At diagnosis, 13 of 16
patients
with active scabies were SPT positive to S. scabiei and 12 of these were
also SPT
and/or radioallergosorbent test positive to HDM. Six patients had
circulating IgE
directed at both S. scabiei and HDM antigens while one subject had IgE to
S. scabiei
only and another had IgE directed at HDM only. Twelve of the 15 subjects
tested also
showed IgE and/or IgG binding to one or more bands on Western blots of an
S. scabiei-
specific protein fraction. This study indicated that approximately half of
the
patients with active scabies had S. scabiei- and HDM-specific circulating
IgE while
most patients cured of scabies lacked S. scabiei- and HDM-specific serum
IgE. The
data also suggested that antibodies to S. scabiei in scabietic patients also
recognize HDM; however, some antibodies were directed at scabies-specific
antigens.

=================================================================
9.) In vitro demonstration of specific immunological hypersensitivity to
scabies mite.
=================================================================
ARTICLE SOURCE: Br J Dermatol (England), Oct 1980, 103(4) p367-73
AUTHOR(S): Falk ES; Bolle R
PUBLICATION TYPE: JOURNAL ARTICLE
ABSTRACT: An extract prepared from 200 adult female scabies mites was used
for prick and intracutaneous testing in twelve patients with previous
scabies infestation, as well as in six healthy controls and three persons
with skin sensitivity to Dermatophagoides pteronyssinus who had never had
scabies before. Seven individuals who had had scabies less than a year
prior to the testing had positive intracutaneous (immediate type)
reactions, whereas all the five who had had scabies more than a year before
had negative reactions. The prick tests were negative in all cases. No skin
reactions could be evoked in the controls. The passive transfer, or
Prausnitz-Kustner, test was positive with the scabies mite extract and
serum from three of five patients tested on one healthy individual, and
with both of two sera tested on a second healthy individual. These findings
indicate that immediate type hypersensitivity reactions may occur with
scabies infection.

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10.) A DNA fingerprinting system for the ectoparasite Sarcoptes scabiei.
=================================================================
Walton SF; Currie BJ; Kemp DJ
Menzies School of Health Research, Casuarina, Australia.
shelley@menzies.su.edu.au
Mol Biochem Parasitol (NETHERLANDS) Apr 1997 85 (2) p187-96 ISSN:
0166-6851
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9709
Subfile: INDEX MEDICUS
We describe multiple hypervariable microsatellites that will provide a
highly
informative genetic marker system for the sarcoptid mite Sarcoptes scabiei.
Eighteen
positive clones containing the highly repetitive sequence (GA)n were
isolated from a
partial genomic library of S. scabiei. Ten of these clones were
characterised by
sequencing and primers were designed from the unique sequences flanking eight
microsatellite loci. Genomic DNA was subsequently extracted from
individual mites
and the repeat blocks were amplified by way of [gamma 33P] ATP end-labelled
polymerase chain reaction. Fragment length polymorphisms were revealed in
three of
the loci when resolved on polyacrylamide sequencing gels. The high levels
of allelic
variability demonstrated between individual mites enable these three loci
to form a
DNA fingerprinting system that will be suitable for epidemiological and
taxonomic
studies both within and between host species.

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11.) The behaviour of Sarcoptes scabiei var. hominis in human skin: an
ultrastructural study.
=================================================================
Fimiani M; Mazzatenta C; Alessandrini C; Paccagnini E; Andreassi L
Department of Dermatology, University of Siena, Italy.
J Submicrosc Cytol Pathol (ITALY) Jan 1997 29 (1) p105-13 ISSN:
0022-4782
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9706
Subfile: INDEX MEDICUS
The biology of Sarcoptes scabiei var. hominis is poorly understood
because of the
lack of an in vivo or in vitro propagation system. To obtain more
information on the
mite behaviour in its natural habitat we conducted an ultrastructural study
of
burrows in a number of patients with common scabies. Scanning electron
microscopy
furnished attractive images of the tunnel, parasite body and eggs
architecture and
demonstrated the presence of holes in the tunnel roof probably representing
aeration
structures. Transmission electron microscopy showed a marked keratinocyte
damage
around burrowing mites, well evident ahead of the mite capitulum also.
Faecal
pellets containing keratinocyte micro-organelles (melanosomes and
mitochondria) were
documented in posterior midgut. For the first time we disclosed the adhesion
mechanism of eggs to the burrow floor. We showed that the typical
finger-like
projections of the outer layer of the egg shell gradually disappear where
the eggs
are in contact with the tunnel floor. This allows the inner layer of the
egg shell
to fuse and stick with the damaged keratinocytes lining the tunnel floor.
Our
observation substantiates that Sarcoptes scabiei produces a proteolytic
substance
(salivary secretions?) that has a key role in its life cycle allowing
burrowing,
feeding and eggs-burrow adhesion.

=================================================================
12.) Immunohistopathological status of the skin in cases infested with
three species of mites.
=================================================================
Yassien NA; Ghoraba HM; Doghaim NN; Afify EM
Department of Parasitology, Faculty
J Egypt Soc Parasitol (EGYPT) Dec 1996 26 (3) p567-73 ISSN: 0253-5890
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9704
Subfile: INDEX MEDICUS
This study was performed on eighty patients with clinical manifestations
of scabies.
Sarcoptes scabiei adult or larva was isolated from 39 patients (48.8%).
Dermanyssus
gallinae (red poultry mite) and Dermatophagoides sp. were isolated from 6
and 5
patients respectively. Punch biopsies were taken from the patients,
stained with
haematoxylin and eosin and direct immunofluorescence stain to study the
immunopathological status of the skin infested with three species of mites.
The
results declared that the pathological changes and the immunoglobulin
deposition in
the skin were nearly similar regardless of the type of the causative mite
with the
except of the presence of burrows in Sarcoptes scabiei.

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13.) Scabietic nodules: a dermatopathologic and immunofluorescent study.
=================================================================
ARTICLE SOURCE: J Cutan Pathol (Denmark), Apr 1992, 19(2) p124-7
AUTHOR(S): Liu HN; Sheu WJ; Chu TL
AUTHOR'S ADDRESS: Department of Dermatology, Veterans General
Hospital-Taipei, Taiwan, R.O.C.
PUBLICATION TYPE: JOURNAL ARTICLE
ABSTRACT: Mites and their eggs were thought to be rarely found in nodular
lesions of scabies. However, serial sections from 27 scabietic scrotal
papules or nodules revealed mite parts in 22% (6/27). This supports the
contention that scabietic nodules may result from persisting antigens of
mite parts. In contrast to previous studies, vasculitis with fibrinoid
degeneration was uncommon (3/27) in our series. This discrepancy may be due
to the timing of the biopsies: 2 of 3 cases with vasculitis were associated
with diffuse dense infiltration, and vasculitis may be a late event in the
development of scabietic nodules. The specificity of immunoreactant
deposits along the epidermodermal junction (EDJ) in scabies is
controversial. In our study, direct immunofluorescence (DIF) was performed
on 13 scabietic nodules. Four (31%) showed immunoreactants at the EDJ and
two on blood vessels. Because of the relatively low positive rate, the low
intensity of fluorescence, and 3 of 4 cases with positive immunoreactants
having only a single class of immunoglobulin, the deposition may only be
secondary to inflammation instead of a specific type II immunologic
reaction to scabies.

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14.) Immunologic cross-reactivity among various strains of Sarcoptes scabiei.
=================================================================
AU: Arlian-LG; Morgan-MS; Arends-JJ
AD: Department of Biological Sciences, Wright State University, Dayton,
Ohio 45435, USA.
SO: J-Parasitol. 1996 Feb; 82(1): 66-72
ISSN: 0022-3395
PY: 1996
LA: ENGLISH
CP: UNITED-STATES
AB: Varieties of Sarcoptes scabiei from different hosts are highly host
specific but they are morphologically indistinguishable. The purpose of
this study was to investigate the immunologic cross-reactivity among
several varieties of scabies mites using serum from a human scabies patient
and from several other species of infested hosts. Homologous and
heterologous crossed-immunoelectrophoretic (CIE) analysis of extracts
prepared from var. canis (dog) and var. suis (pig) mites yielded very
similar antigen profiles. Serum from a human patient infested with var.
hominis had circulating IgE that bound to antigens present in extracts
prepared from each animal mite variety. Antigen homology was further
confirmed by fused peaks on tandem CIE. Additionally, sodium dodecyl
sulfate polyacrylamide gel electrophoresis/immunoblot analysis showed that
the 2 extracts contained proteins that bound antibody in serum from a var.
suis-infested pig, a var. canis-infested dog, var. canis-infested rabbits,
and a var. hominis-infested human. The results of this study clearly
indicate that different varieties of scabies mites, though host specific,
introduce some immunologically cross-reactive molecules into the host.
However, each serum from the 4 scabies-infested hosts also contained
antibody that was specific for proteins in extract from only 1 variety of
mite. These data indicated that each variety of scabies introduced some
unique molecules into the host, each strain produced some similar
molecules, or both, but different hosts responded immunologically to
different sets of these.

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15.) Can house dust mite-triggered atopic dermatitis be alleviated using
acaricides?
=================================================================
Cameron MM
Department of Medical Parasitology, London School of Hygiene & Tropical
Medicine,
U.K.
Br J Dermatol (ENGLAND) Jul 1997 137 (1) p1-8 ISSN: 0007-0963
Language: ENGLISH
Document Type: JOURNAL ARTICLE; REVIEW; REVIEW, TUTORIAL
Journal Announcement: 9711
Subfile: INDEX MEDICUS
House dust mite (HDM) allergens are the most important triggers for atopic
dermatitis. Reducing exposure to these allergens may alleviate clinical
symptoms.
Chemicals with acaricidal activity have been used to treat upholstered
furniture,
carpets and bedding with the aim to reduce HDM allergen exposure. These
chemicals,
by reducing HDM, can decrease the concentration of mite allergens in dust but
improvements in clinical symptoms are not always apparent. Clinical
improvement is
more likely to occur if bedding has been treated rather than carpets and
upholstery.
Future control strategies should be aimed at treating bedding. Permethrin
is a very
efficient killer of mites. It is used topically to treat scabies and head
lice and
is impregnated in bed nets to prevent mosquito bites. Even when applied to
the skin
in high concentrations, it has a very low toxicity in humans and other
mammals.
Permethrin-impregnated bedding may prove to be the best control method in the
treatment of HDM allergen-triggered atopic conditions. (93 References)

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16.) Epiluminescence microscopy. A new approach to in vivo detection of
Sarcoptes
scabiei.
=================================================================
Argenziano G; Fabbrocini G; Delfino M
Clinic of Dermatology, Federico II University of Naples, Italy.
Arch Dermatol (UNITED STATES) Jun 1997 133 (6) p751-3 ISSN: 0003-987X
Language: ENGLISH
Document Type: CLINICAL TRIAL; JOURNAL ARTICLE
Journal Announcement: 9709
Subfile: AIM; INDEX MEDICUS
BACKGROUND: The usual methods of scabies diagnosis include microscopic
identification of the mites and their eggs and feces in skin scrapings. In
many
cases, the results of microscopic examination can be negative owing to the
low number
of parasites present in the cornified layer. Epiluminescence microscopy
(ELM) is an
in vivo technique that allows a detailed inspection of the skin, from the
surface to
the superficial papillary dermis. This is where the scabies mite lives.
In this
study, we evaluate the applicability and the usefulness of ELM for in vivo
diagnosis
of scabies. OBSERVATIONS: Sixty-five (93%) of 70 cases of scabies showed
small,
dark, triangular structures at the sites examined with ELM. A subtle
linear segment
seen below the base of the triangle was made visible by the presence of
small air
bubbles. Together, both structures resembled a jet with contrail. On
traditional
microscopic examination of the scrapings, we verified that the triangular
structure
corresponded to the pigmented anterior section of the mite in all cases.
The linear
segment observed on ELM was thought to be the burrow of the mite along with
its eggs
and fecal pellets. The cases in which the results of a first ELM
examination were
negative demonstrated positive results on a second ELM examination carried
out 20
days later. CONCLUSION: Epiluminescence microscopy is a very useful tool
for in vivo
diagnosis of scabies because it permits Sarcoptes scabiei detection in only
a few
minutes, with no discomfort to the patient and with a very low number of
false-
negative results.

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17.)[Ivermectin and tropical dermatoses]
Ivermectine et dermatoses tropicales.
=================================================================
Caumes E
Service de maladies infectieuses et tropicales, Groupe hospitalier Pitie-
Salp.ANG.etriere, Paris.
Bull Soc Pathol Exot (FRANCE) 1997 90 (1) p37-8
Language: FRENCH Summary Language: ENGLISH
Document Type:
JOURNAL ARTICLE; REVIEW; REVIEW, TUTORIAL English Abstract
Journal Announcement: 9710
Subfile: INDEX MEDICUS
Among tropical dermatoses, the main indications of ivermectine are tropical
parasitoses such as filariasis and cosmopolitan diseases due to
ectoparasites such as
scabies. The efficacy and tolerance of ivermectine in filariasis
(onchocerciasis,
lymphatic filariasis, loiasis) have been the topic of numerous articles and
reviews.
More recent studies showed that ivermectin was also efficient in the
therapy of
scabies, cutaneous larva migrans and larva currens. (17 References)

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18.) Success of a scabies control program in an Australian aboriginal
community.
=================================================================
Carapetis JR; Connors C; Yarmirr D; Krause V; Currie BJ
Menzies School of Health Research, Darwin, Northern Territory, Australia.
jonc@menzies.su.edu.au
Pediatr Infect Dis J (UNITED STATES) May 1997 16 (5) p494-9 ISSN:
0891-3668
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9710
Subfile: INDEX MEDICUS
OBJECTIVE: To adapt, implement and evaluate a model of scabies control in
an
Australian Aboriginal community. METHODS: After initially examining the
population,
we offered all residents treatment with 5% permethrin cream. Visits were
made during
the ensuing 25 months to rescreen and to treat new-cases of scabies and
contacts.
RESULTS: The prevalence of scabies was reduced from 28.8% before the
program to < 10%
during the entire period (from 32.3% to < 10% in children) (P < 0.01 for
each visit).
The initial prevalence of pyoderma in children was 69.4%, which was reduced
and
maintained at approximately one-half that rate during the last 16 months (P
< 0.004
for the last 4 visits). Residual pyoderma in children was significantly
less severe
and no longer scabies-related. CONCLUSIONS: This simplified model of
scabies control
had a substantial effect on scabies prevalence and on pyoderma prevalence and
severity which was sustained for > 2 years. It could prove useful for other
communities with high rates of scabies and pyoderma.

=================================================================
19.) Equivalent therapeutic efficacy and safety of ivermectin and lindane
in the treatment of human scabies.
=================================================================
Arch Dermatol 1999 Jun;135(6):651-5

Chouela EN, Abeldano AM, Pellerano G, La Forgia M, Papale RM, Garsd A,
Balian MC, Battista V, Poggio N
Department of Dermatology, the Hospital General de Agudos Dr Cosme
Argerich, Buenos Aires, Argentina. chouela@impsat1.com.ar

OBJECTIVE: To compare the therapeutic efficacy and safety of ivermectin and
lindane for the treatment of human scabies. DESIGN: Randomized,
prospective, controlled, double-blind, "double-dummy," and parallel
clinical study. SETTING: A single department of dermatology at a hospital
in Buenos Aires, Argentina. PATIENTS: Patients were outpatients,
hospitalized patients, and those referred to our hospital from nursing
homes and asylums. Fifty-three patients had clinical signs and symptoms
compatible with scabies. INTERVENTION: Patients received either a single
oral dose of ivermectin (150-200 microg/kg of body weight) or a topical
application of 1% lindane solution. Treatment was repeated after 15 days if
clinical cure had not occurred. MAIN OUTCOME MEASURES: Clinical healing and
adverse effects. RESULTS: Of 53 patients, 43 (81%) completed the study, 19
in the group treated with ivermectin and 24 in the group treated with
lindane. At day 15, 14 patients (74%; 95% confidence interval, 48.8%-90.8%)
in the group receiving ivermectin showed healing of their scabies and 13
patients (54%; 95% confidence interval, 32.8%-74.4%) in the group treated
with lindane were healed. At 29 days, both treatments resulted in
statistically equivalent therapeutic efficacy: 18 patients (95%; 95%
confidence interval, 74.0%-99.9%) were healed with ivermectin and 23
patients (96%; 95% confidence interval, 78.9%, 99.9%) were healed with
lindane (P<.02). Adverse effects from the treatments were few, mild, and
transient. Results from laboratory tests showed no major abnormalities and
no difference between treatments. CONCLUSIONS: Ivermectin is as effective
as lindane for the treatment of scabies. Ivermectin is simpler to use and,
therefore, is a promising tool to improve compliance and to control
infestations.

=================================================================
20.) The treatment of scabies with ivermectin.
=================================================================
ARTICLE SOURCE: N Engl J Med (United States), Jul 6 1995, 333(1) p26-30
AUTHOR(S): Meinking TL; Taplin D; Hermida JL; Pardo R; Kerdel FA
PUBLICATION TYPE: CLINICAL TRIAL; JOURNAL ARTICLE
ABSTRACT: BACKGROUND. Ivermectin is an anthelmintic agent that has been a
safe, effective treatment for onchocerciasis (river blindness) when given
in a single oral dose of 150 to 200 micrograms per kilogram of body weight.
Anecdotal reports of improvement in patients who suffered from infestation
with the mite Sarcoptes scabiei suggest that the ectoparasitic disease
scabies might be treated with ivermectin. METHODS. We conducted an
open-label study in which ivermectin was administered in a single oral dose
of 200 micrograms per kilogram to 11 otherwise healthy patients with
scabies and to 11 patients with scabies who were also infected with the
human immunodeficiency virus (HIV), 7 of whom had the acquired
immunodeficiency syndrome. All patients received a full physical and
dermatologic examination; scrapings from the skin of all patients tested
positive for scabies. Patients were reexamined two and four weeks after
treatment, when the scrapings for scabies were repeated. The patients used
no other scabicides during the 30 days before ivermectin treatment or
during the 4-week study period. RESULTS. None of the 11 otherwise healthy
patients had evidence of scabies four weeks after a single dose of
ivermectin. Of the 11 HIV-infected patients, 2 had or = 10 scabies lesions
before treatment, 3 had 11 to 49 lesions, 4 had or = 50 lesions, and 2 had
heavily crusted skin lesions. In eight of the patients the scabies was
cured after a single dose of ivermectin. Two patients received a second
dose two weeks after the first. Ten of the 11 patients with HIV infection
(91 percent) had no evidence of scabies four weeks after their first
treatment with ivermectin. CONCLUSIONS. The anthelmintic agent ivermectin,
given in a single oral dose, is an effective treatment for scabies in
otherwise healthy patients and in many patients with HIV infection.

=================================================================
21.) Epidemiology and control of scabies in an Egyptian village.
=================================================================

Hegazy AA, Darwish NM, Abdel-Hamid IA, Hammad SM
Department of Dermatology, Faculty of Medicine, Mansoura University, Egypt.

BACKGROUND: Some studies have addressed the epidemiology of scabies among
rural populations in developing countries; however, the epidemiology of
scabies among the rural population in Egypt is unknown. We sought to
determine the magnitude of scabies infestation in an Egyptian village and
to evaluate the control measures after 1 year. METHODS: This study was
carried out on 3147 residents of Mit-Moaned village in Dakahlia govemorate,
Egypt. It was a cross-sectional follow-up study where the same individuals
examined in round I were re-examined in round III. The two rounds were
separated by a period of 1 year, during which infested patients were
followed up and new cases were discovered (round II). Patients and their
household contacts received treatment with topical permethrin. Patients
showing resistance to permethrin received a single oral dose of ivermectin.
RESULTS: In round III, the overall prevalence rate of scabies was reduced
from 5.4% in round I to 1.1%. The incidence of new cases among susceptible
persons during round II was 1.1%. Scabies was significantly (P < 0.05) more
prevalent among families of large size, high crowding index at night, low
socioeconomic standards, and those receiving their water supply from a hand
pump. Children younger than 10 years showed the highest prevalence.
CONCLUSIONS: Our data provide the first complete picture of the
epidemiology of scabies in rural Egypt. The epidemiologic characteristics
of the disease should be considered in the design of disease control
programs for other villages with scabies epidemics. Our findings revealed
that good control was achieved with the following: increased awareness and
better case finding, education of the staff at the rural health unit,
improved hygiene measures, and massive treatment campaigns using effective
drugs such as topical permethrin and oral ivermectin.

=================================================================
22.) Crusted scabies in two immunocompromised children: successful treatment
with oral ivermectin.
=================================================================
Australas J Dermatol 1999 Feb;40(1):37-40

Patel A, Hogan P, Walder B
Department of Dermatology, Sydney Children's Hospital, Randwick, Australia.

Two immunodeficient children, aged 4 and 12 years, with crusted scabies
were successfully treated with a single oral dose of ivermectin (200
micrograms/kg). One child had been diagnosed in infancy with an undefined
congenital T cell immunodeficiency and the other with chronic mucocutaneous
candidiasis. Both had failed to respond to conventional topical therapy. In
view of the excellent therapeutic response and absence of side-effects,
ivermectin should be considered in the treatment of recalcitrant crusted
scabies in children.

=================================================================
23.) Treatment of scabies with ivermectin.
=================================================================
Eur J Dermatol 1999 Mar;9(2):100-1

Offidani A, Cellini A, Simonetti O, Fumelli C
Clinica Dermatologica, Ospedale Umberto I, Piazza Cappelli 1, 60100 Ancona,
Italy.

The authors report six new cases of patients suffering from severe
infestation with the mite sarcoptes scabiei, treated with ivermectin,
currently the only oral therapy available for this disease. Each patient
received 200 mug/kg of ivermectin, taken as single dose. No topical therapy
was undertaken, except for topical treatment with emollient, as needed. The
drug was very effective in all cases, easy to use, safe, and particularly
useful in those patients with secondary eczematisation and escoriations,
for whom the topical treatments are irritant and less well tolerated.

=================================================================
24.) Efficacy and tolerance of oral ivermectin in scabies.
=================================================================
J Eur Acad Dermatol Venereol 1998 Nov;11(3):247-51

Dourmishev A, Serafimova D, Dourmishev L
Department of Dermatology and Venereology, Medical University, Sofia,
Bulgaria. ald@medun.acad.bg

OBJECTIVE: The aim of this open-label study was to investigate the
therapeutic effect and adverse reactions of oral ivermectin in scabies
patients. BACKGROUND: There is much confusion over reports of efficacy,
adverse reactions and relapses after oral treatment of scabies with
ivermectin. METHODS: Nineteen patients, ten otherwise healthy outpatients
with scabies, and nine inpatients with scabies and another skin disease
(dermatomyositis, 3; pemphigus, 2; bullous pemphigoid, 1; pyoderma, 1; HIV,
1; Behcet's disease, 1) were treated with an oral dose of 0.2 mg/kg
ivermectin (1% water solution) on days 1 and 8. The presence of live mites
and ova in the patient's skin was investigated before, during and after the
treatment. RESULTS: None of the 19 patients with scabies had evidence of
scabies after the second dose of ivermectin. In seven patients we noted the
enhancement of pruritus 24-72 h after the first administration of
ivermectin. In three patients the skin manifestation, vesicle-pustular rash
increased between the second and the fourth day. CONCLUSION: The advantages
of oral ivermectin treatment in scabies patients are: high therapeutic
efficacy against Sarcoptes scabiei, good tolerance and influence of the
drug on the whole skin surface and on clinical symptoms. The administration
of the drug is easy and quick.

=================================================================
25.) Norwegian scabies in a patient with acquired immunodeficiency syndrome.
=================================================================
Dermatology 1998;197(3):306-8

Guggisberg D, de Viragh PA, Constantin C, Panizzon RG
Service de Dermatologie, Centre Hospitalier Universitaire Vaudois,
Lausanne, et Departement Hospitalo-Universitaire Romand de Dermatologie et
Venereologie (DHURDV), Lausanne/Geneve, Suisse.

We report the case of a 42-year-old man with symptomatic HIV infection (C3
CDC stage) who presented widespread hyperkeratotic skin lesions diagnosed
as Norwegian scabies. The CD4 count was 87 cells/mm3. The patient has been
the source of a nosocomial outbreak (20 individuals affected). He was
treated successfully with combined topical treatment (permethrin 5% cream
plus keratolytic agents) and oral ivermectin.

=================================================================
26.) Ivermectin for Sarcoptes scabiei hyperinfestation.
=================================================================
Int J Infect Dis 1998 Jan-Mar;2(3):152-4

Huffam SE, Currie BJ
Royal Darwin Hospital, Menzies School of Health Research, Darwin, Northern
Territory, Australia.

OBJECTIVES: Crusted (Norwegian) scabies is an unusual variant of scabies
caused by hyperinfestation with Sarcoptes scabiei. It has high morbidity,
and secondary bacterial skin sepsis may result in life-threatening
bacteremia. An open label study of oral ivermectin was carried out in
patients with crusted scabies refractory to topical therapy. METHODS:
Patients with refractory crusted scabies were prescribed oral ivermectin,
one to three doses of 200 mg/kg at 14-day intervals, combined with topical
scabicide and keratolytic therapy. RESULTS: Of the 20 patients who received
ivermectin, 8 had a complete initial clinical response, a partial response
was achieved in 9, and minimal improvement occurred in 3. Three doses of
ivermectin were curative for 8 of 10 cases, but recurrence of scabies from
presumed reinfestation occurred in at least half of these. CONCLUSION: The
authors conclude that ivermectin is effective for crusted scabies; however,
multiple doses may be required to achieve a cure, and recurrence 6 or more
weeks after completing treatment is common.

=================================================================
27.) Crusted scabies of the scalp in dermatomyositis patients: three cases
treated with oral ivermectin.
=================================================================
Int J Dermatol 1998 Mar;37(3):231-4

Dourmishev AL, Serafimova DK, Dourmishev LA, Mualla MA, Papaharalambous V,
Malchevsky T
Department of Dermatology and Venereology, University of Medicine, Sofia,
Bulgaria.

BACKGROUND: Cutaneous features in the scalp area among adult patients are
rarely considered as a manifestation of scabies. METHODS: Three patients
with clinical and laboratory data of dermatomyositis with scalp involvement
(fulfill three or four of Bohan and Peter's criteria), of 4 years, 8
months, and 3 years duration, were seen at our department between 1995 and
1996. For relapses of ordinary scabies, they were treated repeatedly with
local scabicide with temporary effect. After a symptom-free period during
the treatment of dermatomyositis with corticosteroids and azathioprine,
they developed diffuse redness with scales and crusts on the scalp areas.
Light microscopy examination of material taken from these crusts showed an
abundance of live mites. RESULTS: All patients were successfully cured of
scabies with a twice oral dose of 200 microg/kg ivermectin within 8 days.
CONCLUSIONS: Our patients with crusted scabies of the scalp and
dermatomyositis prompted us to change our standard diagnostic and
therapeutic regimens. Fascinating features included mimicry of scabies in
patients with dermatomyositis, location of parasites on the scalp,
suppressed cell-mediated immunity and successful cure of mange by ivermectin.

===================================================

 28.)Treatment of Scabies: Comparison of Lindane 1% vs Permethrin 5.
===================================================

Skinmed. 2015 Aug 1;13(4):283-6.
Rezaee E1, Goldust M2, Alipour H3.
Author information
Abstract
Scabies, whose etiologic agent is Sarcoptes scabiei, is a neglected parasitic disease that is a major public health problem in many resourcepoor regions. Its current therapies include benzyl benzoate, lindane, permethrin, sulfur, crotamiton, monosulfiram, and oral ivermectin. The aim of this study was to compare the efficacy and safety of lindane 1% lotion vs permethrin 5% in the treatment of scabies. A total of 120 patients with scabies attending a dermatology outpatient department were included. Patients were randomly divided into two groups. Sixty patients and their family contacts received 5% permethrin cream and the other 60 received 1% lindane lotion. Treatment was evaluated at intervals of 2 and 4 weeks. Permethrin provided improvement in 48 patients (80%) after 2 weeks, whereas lindane was effective in only 28 patients (46.6%). Permethrin (5%) cream was found to be significantly more effective in the treatment of scabies compared with lindane in this study. Adverse effects were rare in both the permethrin and lindane groups.


=========================================================================

  Produced by Dr. Jose Lapenta R. Dermatologist

                 Maracay Estado Aragua Venezuela 2.017  

           Telf: 04142976087-04127766810   



                                                         

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PAROXETINA ASOCIADA A DEPRESION, SUICIDO Y MALFORMACIONES FETALES./PAROXETIN ADVERSE EFFECTS

 

PAXIL (paroxetina) medicina para la depresion, asociada a suicidio y malformaciones fetales !!!


PAXIL (paroxetin) drug for depression linked to suicide, and births defects !!!


Paroxetin (Paxil) adverse effects



PUBLICADO 2007 ACTUALIZADO 2023


 EDITORIAL ESPAÑOL

==============

Medicamento lanzado al mercado en 1.992, años después se revelaron sus efectos adversos

La paroxetina es un medicamento que pertenece a una clase de medicamentos llamados inhibidores selectivos de la recaptación de serotonina (ISRS) y se utiliza para tratar la depresión y otras enfermedades mentales aumentando la cantidad de serotonina, una sustancia natural del cerebro que ayuda a mantener el equilibrio mental.


Se ha informado que una pequeña cantidad de niños, adolescentes y adultos jóvenes (de hasta 24 años) que tomaron antidepresivos como la paroxetina durante los estudios clínicos desarrollaron tendencias suicidas (pensar en hacerse daño o quitarse la vida, o planear o intentar hacerlo)¹. Los niños, adolescentes y adultos jóvenes que toman antidepresivos para tratar la depresión u otras enfermedades mentales pueden ser más propensos a desarrollar tendencias suicidas que aquellos que no toman antidepresivos para tratar dichos trastornos. Sin embargo, también hay riesgos cuando no se trata la depresión en niños y adolescentes.


La paroxetina es un medicamento que pertenece a una clase de medicamentos llamados inhibidores selectivos de la recaptación de serotonina (ISRS) y se utiliza para tratar la depresión y otras enfermedades mentales aumentando la cantidad de serotonina, una sustancia natural del cerebro que ayuda a mantener el equilibrio mental.

OTROS EFECTOS SECUNDARIOS

1. Náusea

2. Somnolencia

3. Sudoración

4. Temblor

5. Astenia

6. Sequedad de boca

7. Disfunción sexual

8.) Malformaciones Fetales.

Saludos a todos
Dr. Jose Lapenta



EDITORIAL ENGLISH
==================
Drug launched on the market in 1992, years later its adverse effects were revealed
Paroxetine is a medication that belongs to a class of medications called selective serotonin reuptake inhibitors (SSRIs) and is used to treat depression and other mental illnesses by increasing the amount of serotonin, a natural substance in the brain that helps maintain Mental balance.

A small number of children, adolescents, and young adults (up to 24 years of age) who took antidepressants such as paroxetine during clinical studies have been reported to become suicidal (thinking about harming or killing oneself, or planning or trying to do so) . Children, adolescents, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than those who do not take antidepressants to treat such disorders. However, there are also risks when depression in children and adolescents is not treated.

Paroxetine is a medication that belongs to a class of medications called selective serotonin reuptake inhibitors (SSRIs) and is used to treat depression and other mental illnesses by increasing the amount of serotonin, a natural substance in the brain that helps maintain Mental balance.

OTHER SIDE EFFECTS

1. Nausea

2. Drowsiness

3. Sweating

4. Tremor

5. Asthenia

6. Dry mouth

7. Sexual dysfunction

8.) Fetal malformations.

Geetings to all

Dr. Jose Lapenta

=====================================================
REFERENCIAS BIBLIOGRAFICAS / BIBLIOGRAPHICAL REFERENCES
=====================================================
1.) FDA: Paxil May Raise Teen Suicide Risk
====================================================

2.) Paroxetina induce al suicidio
=====================================================
3.) Paxil, informacion del producto
=====================================================
4.) Paxil Raises Suicide Risk For Young Adults
=====================================================
5.) Injured by Paxil?
=====================================================
6.) BBC: Glaxo Hid Safety Concerns Related to Seroxat (Paxil)
=====================================================
7.) Even more suicide attempts in clinical trials with paroxetine randomised against placebo
=====================================================
8.) Suicide attempts in clinical trials with paroxetine randomised against placebo.
=====================================================
9.) Paxil increases suicide risk: report
=====================================================
10.) FDA: Paxil Linked To Birth Defects
=====================================================
11.) Se Intensifica la advertencia sobre los defectos de nacimientos a causa del Paxil
=====================================================
 

=====================================================
1.) FDA: Paxil May Raise Teen Suicide Risk
====================================================

Antidepressant Could Have Role In Suicidal Behavior, Says Manufacturer

Source: http://www.cbsnews.com/stories/2006/05/12/health/main1616056.shtml?source=search_story

WASHINGTON, May 12, 2006
--------------------------------------------------------------------------------
Fast Facts

Eight of the 11 suicide attempts were made by patients between the ages of 18 and 30. All trial patients suffered from psychiatric disorders, including major depression.
--------------------------------------------------------------------------------

The antidepressant Paxil may raise the risk of suicidal behavior in young adults, GlaxoSmithKline and the Food and Drug Administration warned Friday in a letter to doctors.

The warning letter was accompanied by changes to the labeling of both Paxil and Paxil CR, a controlled-release version of the drug, also called paroxetine.

A recent analysis of clinical trial data on nearly 15,000 patients treated with both Paxil and dummy pills revealed a higher frequency of suicidal behavior in young adults treated with the drug, according to the letter.

The FDA reported that there were 11 suicide attempts, none resulting in death, among the patients given Paxil in the trials. Just one of the dummy pill patients attempted suicide.

Given that small number, the results "should be interpreted with caution," the FDA said. Eight of the 11 attempts were made by patients between the ages of 18 and 30. All trial patients suffered from psychiatric disorders, including major depression.

GlaxoSmithKline released its findings following an FDA request that antidepressant manufacturers examine their clinical trial data for any links between the drugs and suicide in adults, company spokeswoman Mary Anne Rhyne said.

"At some point, the FDA is going to say what their analysis shows across the category," Rhyne said, adding of her company's own analysis: "We felt like this was information we wanted to share with physicians."

In the letter to doctors, Dr. John E. Kraus, the company's director of clinical development for clinical psychiatry in North America, said GlaxoSmithKline PLC continues to believe the drug's benefits outweigh its risks.

The FDA stressed that all patients, especially young adults and those who are improving, should be carefully monitored when treated with Paxil.

In 2004, the FDA ordered strong warnings about the pediatric risk of suicidal tendencies put on antidepressant labels, and began analyzing whether adults face a similar risk.

All antidepressants now carry warnings on their labels cautioning patients and doctors of the risk of suicidal behavior.

=====================================================
2.) Paroxetina induce al suicidio
=====================================================

Source: http://www.adaptogeno.com/svms/noticias/noticia3.asp

Un estudio reciente revela que el antidepresivo “Paroxetina” incrementa la actividad suicida.


En la última edición de la revista BMC Medicine, se publica un estudio realizado por investigadores del Departamento de Farmacoterapéutica de la Universidad de Oslo, Noruega, quienes evalúan los riesgos de utilizar paroxetina, un conocido antidepresivo.

Los autores analizaron 16 estudios previos en los cuales la paroxetina había sido evaluada mediante estudios aleatorios controlados y registraron el número de suicidios, intentos suicidas e ideación de suicidio. Luego contrastaron los datos contra los tratamientos con paroxetina o placebo.

Este estudio demostró el incremento de los intentos suicidas por año en adultos que utilizan paroxetina.

Los autores concluyen que tanto pacientes como médicos deben ser advertidos de que el aumento de la actividad suicida observada en niños y adolescentes que utilizan paroxetina, puede ocurrir también en adultos.

La paroxetina pertenece a una clase de medicamentos llamados inhibidores selectivos de la recaptación de serotonina, que aumentan la cantidad de serotonina cerebral con el propósito de mantener el equilibrio mental. Es mercadeada con varios nombres comerciales, de los cuales el más popular es “Paxil”.

La paroxetina puede producir otros efectos adversos, tales como: cefalea, mareos, debilidad, dificultad para concentrarse, nerviosismo, amnesia, confusión, somnolencia o sensación de estar narcotizado, dificultad para conciliar o mantener el sueño, acidez o dolor estomacal, vómitos, diarrea, estreñimiento, flatulencia, cambios en la capacidad de degustar los alimentos, disminución del apetito, pérdida o aumento de peso, cambios en el deseo o capacidad sexual, sequedad bucal, transpiración excesiva, bostezos, sensibilidad a la luz, secreción nasal, tos, opresión de garganta, debilidad o dolor osteo-muscular, rubor, problemas dentales, pesadillas, dolor o irregularidad en la menstruación.

Referencia:

Aursnes I, Tvete IF, Gaasemyr J. Suicide attempts in clinical trials with paroxetine randomised against placebo. BMC Med. 2005 Aug 22;3(1):14.

http://www.nlm.nih.gov/medlineplus/spanish/druginfo/medmaster/a698032-es.html

=====================================================
3.) Paxil, informacion del producto
=====================================================
Source: http://www.lawyerseek.com/Practice/En-Espanol-C22/Paxil-P103/


¿Qué es Paxil?

Paxil es un producto comercializado por GlaxoSmithKline, cuyo nombre genérico es hidroclorhidrato de paroxetina. Paxil está clasificado como un inhibidor de la recaptación de serotonina, un tipo de fármacos más conocidos como ISRS. Dentro de esta categoría, también se encuentran otros antidepresivos muy destacados, como Prozac y Zoloft. Paxil se prescribe para el tratamiento de depresión, trastorno obsesivo-compulsivo, trastorno de estrés postraumático y trastornos de pánico y ansiedad. La depresión puede ser un problema muy debilitante que afecta a millones de personas en todo el país, que se traduce en sentimientos de suma tristeza y sensación de inutilidad y desesperanza. Algunos estudios indican que la depresión puede tener origen en un desequilibrio de una sustancia química neurotransmisora del cerebro que se conoce con el nombre de serotonina. Paxil está diseñado para ampliar el uso de la serotonina en el cerebro y así mejorar el envío de los impulsos nerviosos, con la esperanza de tratar los síntomas de la depresión.

Recuadro negro de advertencia sobre Paxil y suicidio infantil

Diversos análisis de ensayos de corto plazo controlados con placebo en los que se investigaron nueve antidepresivos, entre ellos, los ISRS, revelaron que, durante los primeros meses de tratamiento, podría aparecer un aumento de conductas y pensamientos suicidas en niños. En los análisis se contemplaron 24 ensayos en los que participaron 4400 pacientes. Estos estudios indican que podría existir el doble de riesgo de suicidio en los niños a quienes se les administraron antidepresivos, en comparación con los participantes de los estudios que recibieron un placebo. En octubre de 2004, la FDA emitió una advertencia pública respecto de los antidepresivos y los posibles vínculos con un aumento de pensamientos suicidas en niños. La FDA ordenó a los fabricantes de antidepresivos que incluyan un "recuadro negro de advertencia" en las etiquetas de los fármacos, que alerte sobre el posible vínculo de los antidepresivos y el suicidio infantil. Paxil se encuentra entre los fármacos que deben llevar la nueva advertencia, junto con otros antidepresivos populares, como Wellbutrin, Zoloft y Prozac. El recuadro negro es la máxima advertencia que puede emitir la FDA. El texto que contiene el recuadro negro de advertencia debe incorporarse a la etiqueta y, además, a todo aviso publicitario del fármaco. El recuadro negro de advertencia de estos antidepresivos se refiere a la vinculación entre los antidepresivos y el suicidio infantil. Sin embargo, el vínculo entre el tratamiento con antidepresivos y un aumento de los pensamientos o actos suicidas podría aplicarse a adultos, niños y adolescentes.

Advertencia de malformaciones fetales y Paxil

Recientemente, la FDA ha informado que los resultados preliminares de nuevos estudios indican que Paxil podría provocar malformaciones fetales si se administra a mujeres durante el primer trimestre del embarazo (los tres primeros meses del embarazo). Las indicaciones iniciales de dos estudios revelan que las mujeres que tomaron Paxil durante el primer trimestre del embarazo podrían tener entre un 50% y 100% más de probabilidades de que sus hijos tengan defectos cardíacos, en comparación con mujeres en general y las que recibieron otro tipo de medicamentos antidepresivos. Según la FDA, las pacientes embarazadas o que tratan de quedar embarazadas y están tomando Paxil deben discutir con el médico los posibles efectos de este fármaco.

Preguntas y consultas

Si usted o un familiar suyo usaron el fármaco de venta con receta Paxil y han notado efectos secundarios adversos, como pensamientos suicidas o si su bebé sufrió malformaciones fetales, deben ponerse en contacto con un médico de inmediato. Si desea conocer sus derechos, le interesa recibir más información acerca de las causas judiciales sobre Paxil o desea compartir con nosotros información sobre estos casos, complete el breve formulario que se presenta a continuación y un integrante del experimentado personal de Seeger Weiss LLP se comunicará con usted para discutir sus posibles derechos legales por el uso de Paxil. Las consultas a los profesionales no le generan ningún compromiso. Todas las consultas iniciales son gratuitas y no crean una relación abogado-cliente. Seeger Weiss LLP tiene oficinas en Nueva York y Nueva Jersey, y sus profesionales ejercen en los tribunales de todo el país.

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4.) Paxil Raises Suicide Risk For Young Adults
=====================================================

Source: http://www.medicalnewstoday.com/healthnews.php?newsid=43351

GlaxoSmithkline, the makers of the antidepressant, Paxil, have warned that the drug may raise the risk of suicide attempts in people under 30. Glaxo has sent a letter to doctors stating this.

According to a clinical trial, of 3,455 people taking Paxil 11 tried to kill themselves. Among the placebo group of 1,978 people, 1 tried to commit suicide. The majority of suicide attempts were made by patients under 30. One of the Paxil patients who attempted suicide succeeded.

Mary Anne Rhyne, who works for Glaxo, said the company is advising doctors to monitor all patients to make sure their symptoms don't worsen while they are taking Paxil.

The FDA says doctors and patients should follow current advice. The agency is still analysing the results of the trial.

A spokesman for the FDA said it is important that patients on Paxil do not suddenly stop taking their medication without first consulting with their doctors.

Written by: Christian Nordqvist
Editor: Medical News Today

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5.) Injured by Paxil?
=====================================================
Source: http://www.yourlawyer.com/topics/overview/paxil

On December 13, 2006, the FDA announced antidepressants prescribed to young adults are risky. The agency proposed expanding the labels of all antidepressants to include an expanded warning of suicidal thoughts in patients ranging from 18-24 years of age. The newly presented change would expand a warning now on the labels that pertain only to children and adolescents treated with antidepressant drugs. The new label changes would also contain a suggestion that patients of all ages be carefully monitored, particularly when starting antidepressant treatment.

The FDA recently completed a bulk evaluation of 372 studies involving approximately 100,000 patients and 11 antidepressants, including Lexapro, Zoloft, Prozac and Paxil. When the results are analyzed by age, it becomes clear there is an elevated risk for suicidal thoughts and behavior among adults 18 to 25 that approaches that seen in children, the FDA said in documents released before their scheduled December 13, 2006 meeting of its psychopharmacologic drugs advisory committee.

In May 2006, GlaxoSmithKline and the FDA cautioned Paxil may raise the risk of suicidal behavior in young adults too and changed the drug’s label to reflect that risk.

New Paxil Suicide Warning
Paxil (Generic: Paroxetine hci) has been linked with suicide, suicidal ideation and violence in children and teenagers. On May 12, 2006, the FDA issued a Paxil warning when results of a study became public showing that Paxil also increases suicide risk in young adults aged 18-30. An analysis of multiple trials including 15,000 patients revealed 11 attempted suicides among Paxil users and only 1 attempted suicide among those taking the pacebo. Of the 11 suicide attempts in Paxil users, 8 were in people aged 18 to 30. Paxil is most commonly used to treat depression but is also prescribed to treat anxiety, panic, obsessive compulsive disorder, and post traumatic stress disorder. An estimated 17 million people worldwide have been treated with Paxil.

In September 2004, the FDA issued a warning for Paxil, stating that the drug can cause suicide and violence in children and teenagers. This follows a report issued by Britain's Department of Health which said that evidence provided by the drug company from nine studies based on more than 1,000 youngsters shows there is an increase in the rate of self harm and potentially suicidal behavior in those under 18 taking Paxil. British health regulators recently issued a warning and stated: "It has become clear that the benefits of Seroxat in children for the treatment of depressive illness do not outweigh these risks." Following their British counterparts, Irish health officials issued a warning for Paxil in Ireland, and the FDA continues to investigate the suicide risk associated with Paxil and other antidepressants.

Birth Defects
The FDA is strengthening its warning for the antidepressant Paxil because it may be associated with birth defects, citing a new study that found increased risk of fetuses developing heart defects. The FDA asked manufacturer GlaxoSmithKline to reclassify the drug, which goes by the generic name Paroxetine, as a "Category D" drug for pregnant women. The classification means that studies in pregnant women have shown a risk to the fetus. Two studies of pregnant women taking Paxil during their first trimester showed that their babies have heart defects at a rate of 1.5 to 2 times the norm. The FDA is advising doctors not to prescribe Paxil to women in their first three months of pregnancy or people who are planning to become pregnant, unless there are no other options.

Withdrawal Symptoms
Paxil has long been associated with difficult withdrawal side effects, leaving patients virtually addicted to the drug. Recently, The British drug agency required Glaxo to remove a statement on its patient label saying that the drug was not addictive. Paxil has been associated with difficult withdrawal side-effects. Often these withdrawal effects are experienced just hours after a missed dose. Paxil withdrawal symptoms include a "flu-like" syndrome, anxiety, dizziness, fatigue, headache, migraine-like feelings, nerves jangling when moving eyes, continuous indigestion, neck and back pain, psychotic features such as visual and/or audio hallucinations/illusions, insomnia, nausea, restlessness, "electrical shock" phenomena/electrical surges or shocks through the head and/or body, hyper-sensitivity of the nervous system to light, sound, colors & stressors, tremors, tinnitus and a vertiginous-like experience, depressive thoughts, suicidal thoughts, homicidal thoughts, extreme anger, severe agitation, extreme irritability, "over-reacting", ringing in ears and throbbing in head, vomiting, paranoia, aggressive behavior, roller-coaster emotions, out of character behavior, severe malaise, general dysphoria, derealization and panic attacks.

In addition to the aforementioned side effects associated with antidepressants, a new study has linked these drugs to an increased risk of death amongst patients with coronary artery disease. This study, which was conducted at Duke University, analyzed the survival rate of heart disease patients using antidepressants compared with those not using these drugs.

During an average of three years of follow-up, 21.4% of the patients taking antidepressants died compared with 12.5% of those not on antidepressants. After adjusting for demographic factors, cardiac risk factors, scores on the Beck Depression Inventory test, and the presence of other illness, antidepressant use was an independent risk factor for mortality, increasing the risk by 62%.

Researchers do not fully understand why antidepressants increase the risk of mortality in these patients. However their findings are statistically significant and show that these drugs do increase the risk of death in heart disease patients. Current and former heart disease patients should weigh the risks and benefits of antidepressants before using these medications.

If you or a loved one took Paxil and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.


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6.) BBC: Glaxo Hid Safety Concerns Related to Seroxat (Paxil)
=====================================================
Jan 31, 2007

Source: http://www.yourlawyer.com/articles/read/12494

According to journalists at the BBC, GlaxoSmithKline intentionally distorted and covered up damaging information about their antidepressant Seroxat and its link to an increased risk of suicide in children. Researchers for the BBC documentary series Panorama obtained three critical documents suggesting that the company had conducted trials proving the drug was unsafe, but failed to accurately disclose that information. (Seroxat is a brand name for paroxetine, a selective serotonin reuptake inhibitor (SSRI) class of antidepressant marketed in the U.S. as Paxil.)

The BBC’s website reports: “GSK’s biggest clinical trial of Seroxat on children was held in the U.S. in the 1990s and called Study 329. Child psychiatrist Dr. Neal Ryan of the University of Pittsburgh was paid by GSK as a co-author of Study 329. In 2002, he also gave a talk on childhood depression at a medical conference sponsored by GSK. He said that Seroxat could be a suitable treatment for children and later told Panorama reporter Shelley Jofre that it probably lowered rather than raised suicide rates.”

The BBC program quotes U.S. attorney Karen Barth Menzies as saying, “They didn’t tell the regulators or the physicians or parents about these risks or the lack of efficacy; instead they went out and promoted this specific study as remarkably effective and safe for kids.”

The BBC’s Jofre later discovered that, after sending questions about the safety of Seroxat to Ryan in 2002, Ryan forwarded them to GSK asking for advice on how to respond. Jofre also found an email from a public-relations executive, saying, “Originally we had planned to do extensive media relations surrounding this study until we actually viewed the results. Essentially the study did not really show it was effective in treating adolescent depression, which is not something we want to publicize.”

The Panorama investigation also found two other incriminating documents, one from GSK’s marketing department in 1999 that acknowledged the safety risks and another from 2001 that reiterated to its sales staff the safety and efficacy of the drug in treating adolescents even after the company was aware of the side effects.

“Even when they have negative studies that show that this drug Seroxat is going to harm some kids, they still spin that study as remarkably effective and safe for children,” added Menzies, a plaintiff attorney in a U.S. suit facing GSK over the drug.

Roughly 50,000 British children took the drug before it was banned in 2003 for use by patients under the age of 18. The documentary claims that GSK knew of the risks in the late 1990s.

In a statement responding to the BBC allegations, Glaxo says: “No suicides were reported in any of the nine pediatric trials conducted by GSK and when reviewed individually none of these trials were considered by GSK or independent investigators to show a clinically meaningful increase in the rate of suicidal thinking or attempted suicide.

“Only when all the data became available, at the end of the research program, and were analyzed together, was an increased rate of suicidal thinking or attempted suicide revealed in those pediatric patients taking Seroxat.”

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7.) Even more suicide attempts in clinical trials with paroxetine randomised against placebo
=====================================================
.Aursnes I, Tvete IF, Gaasemyr J, Natvig B.

BMC Psychiatry. 2006 Nov 28;6:55.

Department of Pharmacotherapeutics, University of Oslo, Oslo, Norway. i.a.aursnes@medisin.uio.no

Source: http://www.ncbi.nlm.nih.gov/

BACKGROUND: Following our previous publication we have received critical comments to our conclusions as well as new data that are strengthening our findings. RESULTS: With the new data, 11 suicide attempts among patients on paroxetine against 1 among patients on placebo, we found with a Bayesian technique that the posterior probability that medication with paroxetine is associated with an increased intensity per year of a suicide attempt is from 0.98 to 0.99, depending on the prior.We found that the comment to our article by GSK representatives contained errors, misunderstanding and unwillingness to accept Bayesian principles in the analysis of clinical trials. CONCLUSION: We were in our previous publication, with preliminary data and a Bayesian approach, able to raise a concern that suicide attempts might be connected with the use of paroxetine. This suspicion has now been confirmed.

PMID: 17129393 [PubMed - indexed for MEDLINE]

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8.) Suicide attempts in clinical trials with paroxetine randomised against placebo.
=====================================================
Aursnes I, Tvete IF, Gaasemyr J, Natvig B.
Department of Pharmacotherapeutics, University of Oslo, Oslo, Norway. i.a.aursnes@medisin.uio.no
BMC Med. 2005 Aug 22;3:14.

Source: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?itool=abstractplus&db=pubmed&cmd=Retrieve&dopt=abstractplus&list_uids=16115311

BACKGROUND: Inclusion of unpublished data on the effects of antidepressants on children has suggested unfavourable risk-benefit profiles for some of the drugs. Recent meta-analyses of studies on adults have indicated similar effects. We obtained unpublished data for paroxetine that have so far not been included in these analyses. METHODS: The documentation for drug registration contained 16 studies in which paroxetine had been randomised against placebo. We registered the number of suicides, suicide attempts and ideation. We corrected for duration of medication and placebo treatment and used a standard Bayesian statistical approach with varying priors. RESULTS: There were 7 suicide attempts in patients on the drug and 1 in a patient on placebo. We found that the probability of increased intensity of suicide attempts per year in adults taking paroxetine was 0.90 with a "pessimistic" prior, and somewhat less with two more neutral priors. CONCLUSION: Our findings support the results of recent meta-analyses. Patients and doctors should be warned that the increased suicidal activity observed in children and adolescents taking certain antidepressant drugs may also be present in adults.

PMID: 16115311 [PubMed - indexed for MEDLINE]
 

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9.) Paxil increases suicide risk: report
=====================================================
Antidepressant increased suicide attempt in adults, says study, which Glaxo calls "misleading."
August 22, 2005: 1:00 PM EDT

Source: http://money.cnn.com/2005/08/22/news/international/paxil/index.htm

NEW YORK (CNN/Money) - Paxil, a blockbuster antidepressant from British drug maker GlaxoSmithKline, increases the risk of suicide in adults, according to a study by Norwegian researchers

Patients taking Paxil, a $1.9 billion drug also known by its generic term paroxetine, attempted suicide seven times, compared to one suicide attempt in placebo studies, according to a report by Ivar Aursnes and other Norwegian researchers and published in BMC Medicine on Aug. 22.

"Summarizing the suicide attempts, there are seven among the patients on paroxetine and one among the patients on placebo," read the report, which said there were 16 studies conducted with 916 patients on Paxil and 550 on placebo.


GlaxoSmithKline (down $0.06 to $48.15, Research), a London-based drug maker with $39 billion in 2004 sales, criticized the study as "misleading" and based on outdated and "incorrectly selected" data.

"The company disagrees with the conclusion from the sub-analysis conducted by scientists based in Oslo," said GlaxoSmithKline in a prepared statement. "It serves only to cause confusion and unnecessary concern for patients using an SSRI (selective serotonin reuptake inhibitor,) such as paroxetine, for treatment of depression."

The suicidal side effects of antidepressants has raised concerns with the Food and Drug Administration, which now requires all antidepressants to carry warnings about the increased risk of suicide to children and teenagers. On June 30, the FDA said it is conducting a review of available data to determine whether there is an increased risk of suicidal thinking in adults who are taking antidepressants. The FDA expects to take at least a year to complete this review.

The scientists who conducted the Paxil study suggested that adults be included in regulatory warnings.

"We also conclude that the recommendation of restrictions on the use of paroxetine for children and adolescents recently conveyed by regulatory agencies should be extended to include usage by adults," read the report.

To read about the impact of antidepressant suicide risks and other factors on the drug industry's reputation, click here.

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10.) FDA: Paxil Linked To Birth Defects
=====================================================
ut Benefits Of Antidepressant May Outweigh Risk, Agency Says

Source: http://www.cbsnews.com/stories/2005/12/08/health/main1108452.shtml

WASHINGTON, Dec. 8, 2005
--------------------------------------------------------------------------------
Fast Fact

The FDA is advising doctors not to prescribe Paxil to women in their first three months of pregnancy or who are planning to become pregnant.
--------------------------------------------------------------------------------

The Food and Drug Administration is strengthening its warning that the antidepressant Paxil may be associated with birth defects, citing a new study that found increased risk of fetuses developing heart defects.

The FDA asked manufacturer GlaxoSmithKline to reclassify the drug, which goes by the generic name paroxetine, as a "Category D" drug for pregnant women. The classification means that studies in pregnant women have shown a risk to the fetus. However, the FDA said, the benefits of the drug may outweigh the risk to the fetus.

Two studies of pregnant women taking Paxil during their first trimester have shown their babies have heart defects one and a half to two times a greater rate than the norm, the FDA said. The agency announced the strengthened warning Thursday. It issued a previous warning in September.

The FDA is advising doctors not to prescribe Paxil to women in their first three months of pregnancy or people who are planning to become pregnant, unless there are no other options.


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11.) Se Intensifica la advertencia sobre los defectos de nacimientos a causa del Paxil
=====================================================
Un nuevo estudio asocia a Paxil con la causa del doble número de defectos de nacimientos comparados con otros antidepresivos

Source: http://www.webmd.com/content/Article/113/110646.htm


By Miranda Hitti (en Español)

WebMD Medical News Reviewed By Michael Smith, MD (en Español)
on Wednesday, October 05, 2005

27 de septiembre, 2005 - La FDA y la compañía de drogas GlaxoSmithKline están advirtiendo a los doctores sobre un nuevo estudio acerca de los principales efectos de nacimientos que se han visto en los bebés nacidos de mujeres que tomaron el antidepresivo Paxil durante el primer trimestre del embarazo.

"Se les ha aconsejado a los profesionales del cuidado de la salud que consideren cuidadosamente los riesgos potenciales y los beneficios de usar [Paxil] en las mujeres durante el embarazo y discutir estos descubrimientos, también como, las alternativas de tratamientos con sus pacientes," así lo declara la FDA en un comunicado de prensa.

Paxil está asociado con el doble número de defectos de nacimientos

GlaxoSmithKline recientemente llevó a cabo un estudio de los principales defectos de nacimientos en infantes nacidos de mujeres que tomaron antidepresivos (incluyendo Paxil) durante el primer trimestre del embarazo.

De acuerdo a la FDA, en un estudio de más de 3,500 mujeres embarazadas, Paxil fue asociado con el doble número de defectos de nacimientos, así como otros antidepresivos.

Los defectos de nacimientos son muy raros en los EE.UU., y no es seguro qué papel, si hay alguno, Paxil jugó en los defectos de nacimientos vistos en este estudio, lo afirma GlaxoSmithKline.

Los cambios han sido efectuados en la información de la etiqueta que trae Paxil sobre las precauciones en el embarazo, dice la FDA.

GlaxoSmithKline es un patrocinador de WebMD.

La mayoría de los defectos de nacimientos vistos en el estudio estaba relacionada con el corazón; las malformaciones más comunes en el corazón fueron defectos septales ventriculares, los cuales son agujeros entre las dos paredes principales que bombean sangre al corazón. Estos son en general defectos comunes.

El estudio fue un estudio epidemiológico retrospectivo. Eso significa que observaron a un gran grupo de personas posteriormente. No había información sobre los defectos de nacimientos en bebés nacidos de mujeres que no tomaron antidepresivos durante los comienzos del embarazo.

========================================================

  Producido Por Dr. Jose Lapenta R. Dermatologo

           Maracay Estado Aragua Venezuela 2.007-2.023             

 Telf: 04142976087- 04127766810

04166401045

  

         

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domingo, 25 de febrero de 2007

ELIDEL Y PROTOPIC EFECTOS ADVERSOS / ELIDEL AND PROTOPIC ADVERSE EFFECTS

 

ELIDEL (Pimecrolimus) y PROTOPIC (Tacrolimus) EFECTOS SECUNDARIOS !!!


            ELIDEL (Pimecrolimus) and PROTOPIC  (Tacrolimus) ADVERSE EFFECTS !!!            



Tacrolimus y Pimecrolimus asociados a cancer




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."


Greetings

Dr. Jose Lapenta R.

=====================================================
REFERENCIAS BIBLIOGRAFICAS / BIBLIOGRAPHICAL REFERENCES
====================================================
1.) Protopic and Elidel may cause cancer
====================================================

2.) Protopic Causing Cancer
===================================================

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)
=====================================================
 
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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
====================================================
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.

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