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ELIDEL FDA HEALTH ADVISORY & PROTOPIC FDA HEALTH ADVISORY
FDA
Talk Paper
T05-06
March 10, 2005
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Media Inquiries:
301-827-6242
Consumer Inquiries: 888-INFO-FDA
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FDA
Issues Public Health Advisory Informing Health Care Providers of Safety Concerns Associated
with the Use of Two Eczema Drugs, Elidel and Protopic
The Food and Drug Administration (FDA) today advised health care professionals
to prescribe Elidel (pimecrolimus) and Protopic (tacrolimus) only as directed
and only after other eczema treatments have failed to work because of a
potential cancer risk associated with their use. In addition, FDA is adding a
black box warning to the health professional label for the two products and
developing a Medication Guide for patients.
Today’s
actions follow the recommendations made by the FDA’s Pediatric Advisory
Committee during its February 15, 2005 meeting. At this meeting, findings of
cancer in three different animal species were reviewed. The 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 have agreed to 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 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:
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Elidel
and Protopic are approved for short-term and intermittent treatment
of atopic dermatitis (eczema) in patients unresponsive to, or intolerant
of other treatments.
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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.
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Elidel
and Protopic should be used only for short periods of time, not continuously.
The long term safety of these products is unknown.
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Children
and adults with a weakened or compromised immune system should not
use Elidel or Protopic.
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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.
Protopic
was approved in 2000 and Elidel in 2001 to treat eczema.
####
Elidel
(pimecrolimus) Cream and Protopic (tacrolimus) Ointment - (March 10, 2005)
Tacrolimus
(marketed as Protopic Ointment) Information - FDA Alert 3/2005
Pimecrolimus
(marketed as Elidel Cream) Information - FDA Alert 3/2005
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 If
you or a loved one have used Elidel or Protopic and have
been diagnosed with a cancer, tumor,lymphoma, lymph node
disorder or immune systems disorders, then call us for
a Free Initial Consultation. Talk to a Board Certified
Personal Injury Trial Lawyer in Texas with over 20 years
of experience.The Willis Firm is currently representing
several individuals and families with possible complications
from the use of Elidel. Call us now to learn what can be
done to protect your rights and recover the monetary damages
for any injuries that you or your loved one has sustained.
E-Mail
Us
Call 1 800 883 9858
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 Mr.
Willis is a Board Certified Personal
Injury Trial Lawyer, certified by the
Texas Board of Legal Specialization
since 1988. Certification by the Texas
Board of Legal Specialization identifies
an attorney who has been recognized
as having extensive knowledge and actual
experience trying a prescribed number
of personal injury cases to a jury
verdict. In order to be Board Certified,
Mr. Willis had to pass strict testing
and qualification requirements to demonstrate
his knowledge of the law of evidence,
procedure and other areas of substantive
law in the trial of civil cases. Less
than 2% of all Texas attorneys have
earned this important certification.
Toll Free Call
1 800 883 9858
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IMPORTANT NOTICES
There
has been no Elidel Recall or Protopic Recall by the FDA.
Please visit www.fda.gov for more Elidel warnings and Elidel
alerts and Protopic warnings. Elidel & Protopic
are still being prescribed by doctors in the United States.
Elidel is a manufactured by Novartis. If you are having any
problems or side effects while taking Elidel or Protopic,
then please inform you doctor or health care provider of
your symptoms and problems.This website is for informational
purposes only. No information should be relied on as legal
or medical advice or medical research. We encourage all people
to talk with their doctors. It is important that you keep
your doctor informed of your symptoms and follow their advise
about prescription drug and over the counter drug usage,
mixing of different drugs, exercise, health choices, change
of diet, routine drug monitoring and follow-up exams. The Willis Firm is a law firm in Houston,Texas, and will
not give medical advise concerning your usage of this or
any other medication.
The Food and Drug Administration (FDA) has advised health care professionals that Elidel cream (pimecrolimus) and Protopic cream (tacrolimus) have failed to work and that because of a potential Elidel cancer risk associated with their use, that a black box warning for Elidel is forthcoming. Likewise a similar Black Box Warning is forthcoming for Protopic as well. The two eczema creams Elidel and Protopic, must carry a strong warning of cancer risk. The Food and Drug Administration in March 2005, that medical research and studies show that these creams are absorbed into the body and can cause skin cancer and lymphoma. Elidel cream will carry an Elidel “black box” warning, which is the strongest warning carried on drugs and medicines. Likewise, Protopic cream will also carry a Protopic “black box” warning.The FDA Elidel warning contained on the FDA website (www.fda.gov) outlines additional information about Elidel cancer risks and other Elidel side effects and Elidel Warnings not contained on this site.
This law firm strongly urges each parent, guardian of a child / infant or and individual that has used Elidel cream or Protopic cream to talk to their doctor and get medical advice as to whether they are at an increased risk of cancer from Elidel or Protopic usage or whether any additional medical or cancer testing is needed. Studies have shown that with the use of Elidel, lymphoma, skin cancer, tumors and other cancers are increased. Studies have shown the use of Protopic, lymphoma, skin cancer, tumors and other cancers are increased with usage. Please consult your doctor concerning any Elidel infant usage as in a recent FDA Elidel warning, the FDA issued strong concerns against continued usage without consulting your doctor. Our law firm sincerely hopes that any increased risk of Elidel cancer or Protopic cancer or other complications are extremely low and that any person or infant affected can be properly treated and that any residual effect can be medically cured and eliminated from one's body.If you have any medical questions, call you medical doctor. If you have any legal questions, please call the lawyer of your choice or call us for a Free Confidential Consultation at 1-800-883-9858.
Call Toll Free
1-800-883-9858
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Nationwide
Assistance for Victims of Elidel & Protopic Related Injuries 
