ELIDEL (Pimecrolimus) y PROTOPIC (Tacrolimus) EFECTOS SECUNDARIOS !!!
ELIDEL (Pimecrolimus) and PROTOPIC (Tacrolimus) ADVERSE EFFECTS !!!
PUBLICADO 2007 ACTUALIZADO 2023
EDITORIAL ESPANOL
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Las Cremas Elidel (Pimecrolimus) y Protopic (tacrolimus) fueron lanzadas al mercado para tratar el eczema y dermatitis Atópica, aprobadas por la FDA en el año 2.000 y 2001.
Creo nadie pensó que iban a estar asociadas a riesgo de contraer cáncer.
Esta perla es del año 2.005 en que se hicieron los primeros
reportes, el mismo año en que el Dermagic cancelo sus publicaciones.
A
petición de numerosos pacientes el Dermagic esta de regreso y una vez mas
con estas 7 referencias, queda demostrado apocalipticamente y
contundentemente lo que esta ocurriendo con estas cremas y la excelencia
del Dermagic.
....La FDA ha recibido los informes de 78 casos de cáncer, incluso piel y linfoma, en pacientes tratados con Elidel o Protopic.....
Estas cremas nacieron como grandes promesas y adelantos en el tratamiento de la dermatitis atópica, pero el tiempo se encargo de demostrar que su uso prolongado puede inducir la aparición de varios tipos de cáncer
"Elidel (pimecrolimus) y Protopic (tacrolimus) son medicamentos inmunosupresores que se utilizan para tratar ciertas afecciones de la piel. Debido a su acción inmunosupresora, estos medicamentos pueden favorecer el desarrollo de tumores si se absorben en cantidades suficientes a través de la piel y si el tratamiento se mantiene durante tiempos prolongados."
Saludos.
Dr. José Lapenta
EDITORIAL ENGLISH
================
The Creams Elidel (Pimecrolimus) and Protopic (tacrolimus) they were thrown to the market to treat the eczema and Atopic dermatitis, approved by the FDA in the year 2.000 and 2001
I believe nobody thought that they will be associated to risk of
contracting cancer. This pearl is from the year 2.005 when that the first
reports were made, the same year that the Dermagic cancels their
publications.
At the request of numerous patients the Dermagic
is BACK and once, with these 7 references, it is demonstrated
apocalyptically and overwhelmingly what is this happening with these
creams and the excellence of the Dermagic.
......the FDA has received reports of 78 cases of cancers, including skin and lymphoma, in patients treated with both Elidel or Protopic.....
These creams were born as great promises and advances in the treatment of atopic dermatitis, but time took care of demonstrating that their prolonged use can induce the appearance of various types of cancer.
"Elidel (pimecrolimus) and Protopic (tacrolimus) are immunosuppressive drugs used to treat certain skin conditions. Due to their immunosuppressive action, these drugs may promote tumor development if sufficient amounts are absorbed through the skin and if the treatment is maintained for long periods of time."
Dr. Jose Lapenta R.
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REFERENCIAS BIBLIOGRAFICAS / BIBLIOGRAPHICAL REFERENCES
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1.) Protopic
and Elidel may cause cancer
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2.) Protopic Causing Cancer
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3.) PROTOPIC, side effects
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4.)
Alert for Healthcare Professionals Pimecrolimus (marketed as Elidel)
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5.)
Injured by Elidel?
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6.)
Pimecrolimus tópico (Elidel) Español/Spanish
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7.) Cancer warning over eczema creams (Elidel and Protopic)
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1.) Protopic and Elidel may cause cancer
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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
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2.) Protopic Causing Cancer
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Source: http://www.onlinelawyersource.com/
The FDA’s public health advisory announcement about Protopic causing
cancer came in March 2005 after researchers discovered that patients using
this prescription ointment are at an increased risk of developing lymph
node and skin cancer. As a result of Protopic causing cancer, the FDA has
warned doctors and patients of these risks and advised them to only use
Protopic when alternative treatments have failed or cannot be
tolerated.
Protopic is a topical tacrolimus ointment that was
first approved by the FDA in 2000. This prescription medication is used to
treat patients older than two years of age who have moderate to severe
atopic dermatitis, a form of eczema. There are two strengths of Protopic
though only one is approved for pediatric use. Patients who must take this
medication should use it on a short term basis and no longer than
necessary in light of protopic causing cancer.
In addition to
concerns about protopic causing cancer, there are certain patient
populations for whom Protopic use is contraindicated. Women who are
pregnant or breastfeeding should not use Protopic. Patients whose atopic
dermatitis is infected should also not use this product. Patients with
Netherton’s syndrome, a genetic condition marked by significant skin
irritation, should also not use this topical ointment.
Information
about protopic causing cancer was collected from animal studies, human
case studies, and scientific knowledge about how this medication works. In
animal studies, researchers found that those treated with protopic
developed lymph node and skin cancer tumors at a faster rate than those
not given protopic. Human case studies show protopic causing cancer in
human subjects as well. The FDA has stated that it will take at least ten
years of human clinical trials to determine the extent of protopic causing
cancer risks.
In addition to protopic causing cancer, use of
this prescription medication also carries other risks. Patients using
protopic may experience common skin irritations including stinging,
burning, itching, redness and soreness, headaches, and influenza-like
symptoms. Protopic users are at an increased risk of developing some viral
infections including chicken pox and shingles. Exposure to sunlight or
tanning beds can also increase the chances of protopic causing cancer.
If
you or a loved one has used protopic tacrolimus ointment, you may wish to
speak with your health care professional about the risks of protopic
causing cancer. Patients should only use this product exactly as directed
by a doctor for the shortest duration of treatment possible. A doctor will
inform you of the way to use the ointment in order to mitigate the risk of
protopic causing cancer.
If you or a loved one has developed
cancer while using protopic ointment, you may wish to explore your legal
rights and options with regards to seeking compensation for your losses. A
highly trained and experienced attorney can help to protect and maximize
your legal interests in a case involving protopic causing cancer.
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3.) PROTOPIC, side effects
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Source: Http://www.medicalmalpractice.com/
1.) What is Protopic?
2.) What is eczema?
3.) Side Effects
4.)
2005 FDA Warning over Protopic Cancer
5.) 2006 Protopic Cancer BLACK
BOX WARNING
6.) Injured by Protopic?
On January 19, 2006,
the FDA announced the approval of a BLACK BOX WARNING for Protopic
Ointment to warn of the serious risk of cancer posed by this topical
prescription medication. Evidence shows that Protopic increases the risk
of skin cancer and lymphomas. If you or a loved one has developed cancer
or other serious side effects while using Protopic, please contact us at
Oshman & Mirisola to learn more about your legal rights and options.
You may be eligible to receive compensation for your losses and
suffering.
1.) What is Protopic?
The FDA approved
Protopic (tacrolimus ointment) in 2000. This topical ointment is used to
treat moderate to severe atopic dermatitis, also known as eczema. Protopic
is not intended for use in children under the age of two. Astellas Pharma,
Inc. (formerly known as Fujisawa Healthcare) manufactures Protopic
ointment. Due to known Protopic side effects, this medication should only
be used for a short period of time. Protopic is not intended for long-term
use.
Experts also warn that Protopic should only be used as a
“second-line” treatment when other medications have not successfully
treated a patient’s eczema. Protopic may also be recommended when other
medications have caused significant side effects. Nonetheless, Protopic
should only be prescribed as a last resort treatment of eczema.
2.)
What is eczema?
Eczema, or atopic dermatitis, is one of the
most common skin conditions experienced by infants and young children.
Experts estimate that 10 to 15 percent of all children suffer from eczema.
In the majority of cases, eczema is resolved by the time these children
enter their teens. However, for some patients, treatments are necessary to
treat eczema.
Eczema is characterized by chronically itchy,
dry, red, and scaly skin. Because patients often have an overwhelming urge
to scratch at infected areas, significant skin damage can result. Although
the exact cause of eczema is unknown, many experts believe there is an
allergic or immune component to the condition.
Protopic, and a
similar drug called Elidel (marketed by Novartis AG), are approved to
treat eczema. While the exact function of these topical drugs are not well
understood, it is thought that Protopic and Elidel have various effects on
the immune system.
3.) Protopic Side Effect Risks
Serious
Protopic side effects can include:
VIRAL INFECTIONS
Protopic can increase the risk of getting shingles, chicken pox, or other
viral infections.
SKIN IRRITATION While Protopic is intended to
relieve symptoms of skin irritation, this drug can also aggravate skin
problems. Protopic side effects can include stinging, soreness, a burning
sensation, or itchy skin.
FLU-LIKE SYMPTOMS Protopic can cause a
patient to develop symptoms of the flu and headaches. This may be due to
the drug’s effects on the immune system.
SKIN CANCER AND LYMPHOMA
Protopic cancer is a serious risk associated with this medication.
4.) 2005 FDA Warning over Protopic Cancer
In March 2005, the
FDA issued an advisory warning to inform consumers about the rare but
serious risk of Protopic cancer. Based on information from animal studies,
human case studies, and knowledge of the drug’s function, Protopic appears
to increase the risk of developing skin cancer and lymph node cancer
(lymphoma).
Studies also show that skin tumors developed faster
in subjects, treated with Protopic, who have been exposed to light.
Therefore, patients undergoing light therapy for their skin condition,
other forms of phototherapy, or those with a lot of exposure to the sun,
may be at an increased risk for Protopic cancer.
When the FDA
advisory warning was issued, the FDA stated that it might take ten or more
years to determine if Protopic is undeniably linked to cancer. They
announced that further studies would be conducted to learn more about the
serious risks of Protopic cancer.
5.) 2006 Protopic Cancer
BLACK BOX WARNING
In January 2006, the FDA announced that a
black box warning, the strictest warning short of a recall, would be added
to Protopic labeling to warn of the serious risks of cancer. The agency
also issued a Medication Guide to help ensure that patients are aware of
the serious risks of Protopic cancer.
The Protopic black box
warning also reiterates that Protopic should only be used as a second-line
treatment in patients who have not received relief from other medications
who do not have any risk factors for Protopic side effects. Protopic’s
maker and the FDA state they will continue to evaluate Protopic safety to
determine the exact causation between this drug and various forms of
cancer.
6.) Injured by Protopic?
If you or a loved
one has suffered serious Protopic side effects, please contact us to speak
with a qualified attorney at Oshman & Mirisola about your legal rights
and options. We are experienced in handling cases of a similar nature and
are prepared to protect and maximize your legal interests. You may be
eligible to seek compensation for your losses and suffering.
Contact
Us
