| The
Protopic (Tacrolimus) an Elidel (pimecrolimus) linked to cancer!
Protopic y Elidel, cremas vinculadas a cancer !!!
Data-Medicos
Dermagic/Express No. 9-(126)
25 Febrero 2.007 / 25 February 2.007
THE
PIMECROLIMUS AND THE ATOPIC DERMATITIS !!!
05/11/02
(hot link)
EDITORIAL ESPANOL
=================
Las Cremas Elidel (Pimecrolimus) y Protopic (tacrolimus)
fueron lanzadas al mercado para tratar el eczema y dermatitis Atopica,
aprobadas por la FDA en el año 2.000 y 2001.
Creo nadie penso que iban a estar asociadas a riesgo de
contraer cancer. 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 peticion 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.....
Saludos.
Dr. Jose 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.....
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)
=====================================================
=====================================================
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.
===================================================
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.
Contact Us
====================================================
4.) Alert for Healthcare Professionals Pimecrolimus (marketed as Elidel)
=====================================================
Source:
http://www.fda.gov/cder/drug/InfoSheets/HCP/elidelHCP.htm
FDA ALERT [3/2005]:
The FDA has issued a public health advisory to inform healthcare
professionals and patients about a potential cancer risk from use of
Elidel (pimecrolimus). This concern is based on information from animal
studies, case reports in a small number of patients, and knowledge of
how drugs in this class work. It may take human studies of ten years or
longer to determine if use of Elidel is linked to cancer. In the
meantime, this risk is uncertain, and FDA advises Elidel should be used
only as labeled, for patients after other prescription treatments have
failed to work or cannot be tolerated.
This information reflects FDA’s preliminary analysis of data concerning
this drug. FDA is considering, but has not reached a final conclusion
about, this information. FDA intends to update this sheet when
additional information or analyses become available.
--------------------------------------------------------------------------------
To report any unexpected adverse or serious events associated with the
use of Elidel, please contact the FDA MedWatch program at 1-800-FDA-1088
or
http://www.fda.gov/medwatch/report/hcp.htm
Recommendations
Physicians with patients using Elidel, or who are considering
prescribing the drug, should consider the following:
Use Elidel only as second-line agent for short-term and intermittent
treatment of atopic dermatitis, a form of eczema, in patients
unresponsive to, or intolerant of other treatments.
Avoid use of Elidel in children younger than 2 years of age. The effect
of Elidel on the developing immune system in infants and children is not
known. In clinical studies, infants and children younger than 2 years
old treated with Elidel had a higher rate of upper respiratory
infections than those treated with placebo cream.
Use Elidel only for short periods of time, not continuously. The long
term safety of Elidel is unknown.
Children and adults with a weakened or compromised immune system should
not use Elidel.
Use the minimum amount of Elidel needed to control the patient’s
symptoms. In animals, increasing the dose resulted in higher rates of
cancer.
Data Summary
Although pimecrolimus is not genotoxic and does not interact directly
with DNA, it may have a potential to impair local immunosurveillance.
Repeat dose studies conducted with topical application of pimecrolimus
in mice demonstrated a dose and treatment dependent development of
lymphoma. Carcinogenicity studies conducted with oral administration of
pimecrolimus in mice demonstrated a dose dependent development of
lymphoma and benign thymoma. Carcinogenicity studies conducted with
topical administration of pimecrolimus in rats demonstrated development
of follicular cell adenoma of the thyroid. Data from a recently
conducted oral nine-month monkey study showed a dose-related increase in
virus-associated lymphoma following administration of pimecrolimus.
As of December 2004, the FDA had received 10 cases of postmarketing
reports linking Elidel with cancer-related adverse events. Four cases
occurred in children, 3 of these in children less than 6 years of age.
The other 6 cases occurred in adults.
Of the 10 postmarketing cases reporting cancer, 6 described cutaneous
tumors, 1 described a lymph node/cutaneous tumor related event, and the
locations of 3 others were unreported. Four cases described lymphomas; 5
cases described a variety of tumors, including basal cell carcinoma and
squamous cell carcinoma; and 1 case described granulomatous
lymphadenitis. The median time until diagnosis after initiation of
treatment with Elidel was 90 days, with a range between 1 week and 300
days. Two cases also reported a lymphadenopathy. Two cases were
confounded, 1 with the presence of nodules prior to the diagnosis of
basal cell carcinoma; and another with a pre-existing condition
associated with an increased risk for malignant transformation.
Elidel is sometimes absorbed through the skin, though usually at very
low amounts. Occasionally, children who have been treated with Elidel
have had measurable blood levels of the drug. The potential for systemic
immunosuppression is unknown and the role of Elidel in the development
of the cancer-related events in the individual postmarketing cases is
also uncertain.
FDA Patient Information Sheet
http://www.fda.gov/cder/drug/InfoSheets/patient/ElidelPIS.pdf
Questions? Call Drug Information, 1-888-INFO-FDA (automated)
or 301-827-4570
[email protected]
Date created: February 14, 2005, updated June 15, 2006
===================================================
5.) Injured by Elidel?
====================================================
Source:
http://www.yourlawyer.com/topics/overview/elidel
Elidel, manufactured by Novartis, was approved by the FDA in December
2001. Elidel is prescribed to treat Eczema and is also commonly
prescribed off-label for psoriasis and dermatitis seborrhea.
On March 10, 2005, the FDA stated that Elidel should carry a strong
advisory about cancer risks. Research shows that the cream is absorbed
into the body and may have the potential to cause cancer. The FDA is
working on a ″black box″ warning for Elidel. The data collected by the
FDA showed that the risk of cancer increased as the amount of the drug
given increased. This data also included a small number of reports of
cancers in children and adults treated with Elidel. Elidel and similar
medications suppress the immune system, which may be a precipitating
factor in the development of cancer. Elidel has become widely prescribed
as an alternative to steroid creams, which also have long-term side
effects.
On January 20, 2005, the FDA declared that Elidel must bear "black box"
warnings of possible cancer risks. The new labeling will also recommend
that the drug be prescribed for use only after other prescription
topical medicines have been tried by patients. The FDA is also issuing a
guide updating patients of its concerns. A black box warning is the most
serious type of warning in prescription drug labeling. The warning will
be located lower on the labels of the two drugs than is typical,
although a statement higher on the labels will refer to the risk. As of
October, the FDA has received reports of 78 cases of cancers, including
skin and lymphoma, in patients treated with both Elidel or Protopic,
said Dr. Stanka Kukich, the acting director of the FDA's dermatologic
and dental drug products division.
If you or a loved one took Elidel and suffered side effects, please fill
out the form at the right for a free case evaluation by a qualified drug
side effects attorney.
Elidel
FDA Orders 'Black Box' Warning for Eczema Drugs, Elidel and ProtopicJan
21, 2006 | www.Newsinferno.com
In an important notification, the Federal Drug Administration (FDA) has
announced the approval of updated labeling for two topical eczema drugs,...
More »
FDA to Require Warnings on 2 Eczema DrugsJan 20, 2006 | AP
The labels on two prescription creams to treat eczema will have to bear
"black box" warnings of possible cancer risks.The Food and Drug...
More »
Health Alert for Eczema PatientsMay 3, 2005 | www.cfcn.ca
Health Canada and the U-S Food and Drug Administration have issued
health alerts on two Eczema skin creams.But Canadian dermatologists say
the...
FDA Panel Urges Warnings on 2 Eczema DrugsFeb 16, 2005 | Washington Post
A prescription cream and an ointment that millions of Americans use to
control eczema should carry strong warnings to alert consumers that the
drugs...
More »
FDA Considers Warnings for Eczema CreamsFeb 12, 2005 | Washington Post
Government scientists, concerned that two prescription creams used
widely for a common skin condition may increase the risk of certain
cancers,...
=====================================================
6.) Pimecrolimus tópico (Elidel)
===================================================
Source:
http://www.nlm.nih.gov/medlineplus/spanish/druginfo/medmaster/a603027-es.html
¿Para cuáles condiciones o enfermedades se prescribe este medicamento?
El pimecrolimus se usa para controlar los síntomas de la dermatitis
atópica (una enfermedad que afecta la piel también llamada eccema).
Pimecrolimus sólo se usa para tratar a aquellos pacientes que no pueden
tomar otros medicamentos para tratar la dermatitis atópica, o cuyos
síntomas no han sido controlados por otros medicamentos. Pimecrolimus
pertenece a una clase de medicamentos llamados inmunodepresores.
Funciona al prevenir la activación de ciertas células que causan prurito
(picazón) y enrojecimiento de la piel.
¿Cómo se debe usar este medicamento?
Pimecrolimus viene envasado en forma de crema para aplicar sobre la
piel. Se aplica, por lo general, 2 veces al día durante 6 semanas cada
vez. Siga cuidadosamente las instrucciones en la etiqueta del
medicamento y pregúntele a su doctor o farmacéutico cualquier cosa que
no entienda. Use el medicamento exactamente como se indica. No use más
ni menos que la dosis indicada ni tampoco más seguido que lo prescrito
por su doctor.
Usted no debe usar la crema pimecrolimus en forma regular durante mucho
tiempo. Sólo debe aplicarla cuando tenga síntomas de dermatitis atópica.
Llame a su doctor cuando los síntomas desaparezcan para determinar si
usted debe dejar de usar el medicamento. También llame a su doctor tan
pronto como note que los síntomas han regresado para determinar si usted
debe comenzar a usar pimecrolimus nuevamente.
Puede tomar 2 semanas o más antes de que usted sienta el beneficio total
de este medicamento, pero los síntomas deberían desaparecer dentro de 6
semanas. Llame a su doctor si los síntomas empeoran en cualquier momento
durante el tratamiento o si no mejoran después de haber usado el
medicamento por 6 semanas.
Para usar la crema, siga estos pasos:
Lávese las manos con agua y jabón.
Aplique una capa delgada de crema a todas las zonas afectadas de la
piel. Usted puede aplicar pimecrolimus a todas las superficies afectadas
de la piel incluyendo la cabeza, cara y cuello. Evite el contacto del
medicamento con los ojos y la boca.
Frote suavemente la crema sobre la piel.
Lávese las manos con agua y jabón para remover los residuos del
medicamento. No se lave las manos si están siendo tratadas con
pimecrolimus.
Usted puede cubrir las áreas que están siendo tratadas con ropa, pero no
use vendas, apósitos ni envuelva el área.
Asegúrese de no lavar la crema de las áreas afectadas. No nade, no se
duche ni se bañe inmediatamente después de aplicar la crema.
¿Qué otro uso se le da a este medicamento?
Este medicamento también puede ser prescrito para otros usos; pídale más
información a su doctor o farmacéutico.
¿Cuáles son las precauciones especiales que debo seguir?
Antes de comenzar a usar pimecrolimus:
dígale a su doctor y a su farmacéutico si usted es alérgico al
pimecrolimus o a otros medicamentos.
dígale a su doctor y a su farmacéutico qué medicamentos con y sin
prescripción está tomando, como por ejemplo vitaminas, suplementos
nutricionales y productos fabricados a base de hierbas. Asegúrese de
mencionar los siguientes: antifúngicos como fluconazol (Diflucan),
itraconazol (Sporanox) y ketoconazol (Nizoral); bloqueadores de los
canales de calcio como diltiazem (Cardizem, Dilacor, Tiazac, otros), y
verapamilo (Calan, Isoptin, Verelan); cimetidina (Tagamet);
claritromicina (Biaxin); ciclosporina (Neoral, Sandimmune); danazol (Danocrine);
delavirdina (Rescriptor); eritromicina (E.E.S., E-Mycin, Erythrocin);
fluoxetina (Prozac, Sarafem); fluvoxamina (Luvox); inhibidores de la
proteasa del VIH como indinavir (Crixivan), y ritonavir (Norvir);
isoniazida (INH, Nydrazid); metronidazol (Flagyl); nefazodona (Serzone);
anticonceptivos orales (píldoras anticonceptivas); otros ungüentos,
cremas o lociones; troleandomicina (TAO); y zafirlukast (Accolate). Su
doctor podría cambiar la dosis de su medicamento o vigilarle
cuidadosamente para detectar la aparición de efectos secundarios.
dígale a su doctor si usted tiene o alguna vez ha tenido enfermedades
que afectan el sistema inmunitario como cáncer, síndrome de
inmunodeficiencia adquirida (SIDA), o síndrome severo combinado de
inmunodeficiencia; síndrome de Netherton (un tipo de enfermedad que
afecta la piel), o cualquier tipo de infección a la piel, especialmente
varicela, culebrilla, herpes o eccema herpeticum. También dígale a su
doctor si usted está siendo tratado con cualquier forma de terapia
liviana como fototerapia, UVA o UVB.
dígale a su doctor si está embarazada, tiene planes de quedar embarazada
o si está amamantando. Si queda embarazada mientras usa este
medicamento, llame a su doctor de inmediato.
evite la exposición innecesaria o prolongada a la luz solar y use ropa
que cubra su piel, gafas de sol y filtro solar. También evite la
exposición a la luz solar artificial como lámparas de sol y camas de
bronceado. La crema de pimecrolimus puede aumentar el riesgo de que
usted contraiga cáncer de piel si su piel está expuesta a la luz solar.
evite la exposición a la varicela, herpes y otros tipos de virus. Si
usted está expuesto a una de estas enfermedades mientras usa
pimecrolimus, llame a su doctor de inmediato.
usted debe saber que el cuidado de la piel y los humectantes pueden
ayudar a aliviar los síntomas provocados por esta condición. Pregúntele
a su doctor qué crema humectante debe usar y aplíquela siempre después
de usar pimecrolimus.
¿Qué dieta especial debo seguir mientras tomo este medicamento?
Converse con su doctor sobre el consumo de jugo de toronjas (pomelos)
mientras usa este medicamento.
¿Qué tengo que hacer si me olvido de tomar una dosis?
Aplique la dosis que olvidó tan pronto como lo recuerde, sin embargo, si
es hora para la siguiente, sáltese aquella que no aplicó y siga con la
dosificación regular. No aplique una dosis doble para compensar la que
olvidó.
¿Cuáles son los efectos secundarios que podría provocar este
medicamento?
Pimecrolimus puede provocar efectos secundarios. Dígale a su doctor si
cualquiera de estos síntomas se vuelve severo o si no desaparece:
ardor, o enrojecimiento en las áreas donde se aplicó el medicamento
(llame a su doctor si el enrojecimiento dura más de 1 semana)
cefalea (dolor de cabeza)
tos
congestión nasal o rinorrea (secreción nasal), o enrojecimiento de la
nariz
Algunos efectos secundarios podrían provocar graves consecuencias para
la salud. Los siguientes síntomas son poco comunes, pero si experimenta
alguno de ellos, llame a su doctor de inmediato:
dolor o enrojecimiento en la garganta
fiebre
síntomas similares a los de la gripe
dolor, supuración y signos de otro tipo de una infección en los oídos
verrugas, protuberancias o crecimientos de otro tipo en la piel
inflamación en las glándulas del cuello
Algunos pacientes contrajeron cáncer de piel o cáncer en los ganglios
linfáticos mientras estaban usando la crema pimecrolimus. No se sabe si
la crema pimecrolimus fue la causante del cáncer que se desarrolló o si
los pacientes habrían desarrollado cáncer aunque no hubieran usado el
medicamento. Converse con su doctor acerca de los riesgos de usar la
crema pimecrolimus.
Pimecrolimus puede provocar otros efectos secundarios. Llame a su doctor
si tiene cualquier problema inusual mientras toma este medicamento.
¿Cómo debo almacenar este medicamento?
Mantenga este medicamento en su envase, bien cerrado y fuera del alcance
de los niños. Almacénelo a temperatura ambiente y lejos del calor
excesivo y la humedad (no en el baño). Deseche cualquier medicamento que
esté vencido o que ya no se utilice. Converse con su farmacéutico acerca
del desecho adecuado de los medicamentos.
¿Qué debo hacer en caso de una sobredosis?
Si alguien ingiere la crema pimecrolimus, llame a la oficina local de
control de envenenamiento al 1-800-222-1222. Si la víctima está
inconsciente, o no respira, llame inmediatamente al 911.
¿Qué otra información de importancia debería saber?
Cumpla con todas las citas con su doctor.
No deje que otras personas usen su medicamento. Pregúntele al
farmacéutico cualquier duda que tenga sobre cómo renovar la prescripción
de su medicamento.
Marca(s) comercial(es):
Elidel
===================================================
7.) Cancer warning over eczema creams (Elidel and
Protopic)
=====================================================
Source;
http://news.bbc.co.uk/1/hi/health/4339317.stm
US authorities have ruled two eczema creams should carry
warnings that they may increase the risk of cancer.
The Food and Drug Administration said research had shown that Elidel and
Protopic may pose a cancer risk when absorbed into the body.
It said babies should not be treated with the creams at all.
The view is strongly disputed by the manufacturers, Novartis, which
makes Elidel, and Fujisawa Pharmaceutical, which makes Protopic.
Any patient or parent of a patient who has concerns about their
treatment or their child's treatment should speak to their doctor
Medicines and Healthcare products Regulatory Agency
The FDA is working on a "black box" warning for the creams - the
strongest warning carried by medicines in the US.
In a statement it said animal studies had shown a potential link with
cancer.
There were also reports of seven cases of lymphoma and six of skin
cancer among children and adults treated with Elidel or Protopic.
Both creams work by suppressing the immune system. Depressing immune
activity in this way is known to potentially contribute to cancer.
Monitoring
A spokesperson for the UK's Medicines and Healthcare products Regulatory
Agency said it was closely monitoring the safety of the creams.
These are valuable medications, and if used properly they significantly
reduce the debilitating impact of eczema
Dr Clay Cockerell
"Any patient or parent of a patient who has concerns about their
treatment or their child's treatment should speak to their doctor."
Margaret Cox, chief executive of the UK's National Eczema Society, told
the BBC News website the creams already came with strong warnings about
their over-use in this country.
"Because they are new treatments one does have to recognise that the
long term effects are uncertain," she said.
"To date we haven't had any evidence of direct causality between topical
application of these creams in humans and cancer."
Company defence
Novartis dismissed claims Elidel could increase the risk of cancer, and
said it planned no immediate change in its product label.
National Institute for Clinical Excellence guidance
Treatment with tacrolimus (Protopic) or pimecrolimus (Elidel) should be
initiated only by physicians with a special interest and experience in
dermatology, and only after careful discussion with the patient about
the potential risks and benefits of all appropriate second-line
treatment options
In a statement it said: "Novartis agrees that patients suffering from
mild to moderate eczema need to be informed about the safe and effective
use of Elidel, but we believe a recommendation to add a black box
warning to the label is unsubstantiated by clinical evidence and
experience in more than five million patients worldwide."
Fujisawa Pharmaceutical said it had not found any data to clearly link
Protopic to cancer, and believes it has provided sufficient information
to ensure the drug is used safely.
The American Academy of Dermatology (AAD) has also questioned the FDA
move, arguing that virtually none of the creams would get inside the
body.
Dr Clay Cockerell, ADD president, said: "These are valuable medications,
and if used properly they significantly reduce the debilitating impact
of eczema and allow millions of our patients to live normal lives."
In February, members of an FDA advisory panel said they were concerned
the companies were aggressively advertising the medicines to treat
infants and others with skin problems that the creams are not approved
to treat.
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DATA-MEDICOS/DERMAGIC-EXPRESS No 9-(126) 25/02/2.007 DR. JOSE
LAPENTA R.
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