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ELIDEL CANCER SIDE EFFECT RISKS – POSSIBLE
PROTOPIC CANCER READ FDA HEALTH WARNING
March
10, 2005
FDA
Public Health Advisory
Elidel (pimecrolimus) Cream and Protopic (tacrolimus) Ointment
The
FDA is issuing a public health advisory to inform healthcare providers and
patients about a potential cancer risk from use of Elidel (pimecrolimus) and
Protopic (tacrolimus), products that are applied to the skin. This concern is
based on information from animal studies, case reports in a small number of
patients, and how these drugs work. It may take human studies of ten years or
longer to determine if use of Elidel or Protopic is linked to cancer. In the
meantime, this risk is uncertain and FDA advises that Elidel and Protopic
should be used only as labeled, for patients who have failed treatment with
other therapies.
The FDA recommends that healthcare providers, patients and caregivers consider
the following:
- Use Elidel and
Protopic only as second-line agents
for short-term and intermittent treatment of atopic dermatitis (eczema) in
patients unresponsive to, or intolerant of other treatments.
-
Avoid use of
Elidel and Protopic in children younger than 2 years of age. The effect of
Elidel and Protopic 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 did
those treated with placebo cream.
-
Use Elidel and
Protopic only for short periods of time, not continuously. The long term
safety of Elidel and Protopic are unknown.
-
Children and
adults with a weakened or compromised immune system should not use Elidel or
Protopic.
-
Use
the minimum amount of Elidel or Protopic needed to control the patient’s symptoms.
In animals, increasing the dose resulted in higher rates of cancer.
Elidel
cream and Protopic ointment are topical immunosuppressant calcineurin
inhibitors that are applied to the skin and are the only approved drug
products in this class.
Animal studies have shown that three different species of animals developed
cancer following exposure to these drugs applied topically or given by mouth,
including mice, rats and a recent study of monkeys. These studies were
conducted at doses higher than generally used by patients and the risk of
cancer increased with increasing drug dose and duration.
In addition to an ointment, tacrolimus, also comes as a pill or by injection,
this form is known as (Prograf). Prograf is approved to prevent liver or
kidney transplant rejection. It is known to cause both skin cancers and
lymphoma in humans by suppressing the body’s normal immune defenses against
cancer. The cancer risk increases with higher doses and longer treatment
courses of Prograf. Both Elidel and Protopic are sometimes absorbed through
the skin, though usually at very low amounts. Occasionally, children who have
been treated with Elidel or Protopic have had high blood levels of these
drugs.
Protopic was approved in December 2000 and Elidel in December 2001. Since
their approval, FDA has received reports of lymphoma and skin cancer in
children and adults treated with Elidel or Protopic; whether the reported
cancers are associated with these products has not been clearly established.
Based on the advice of the FDA Pediatric Advisory Committee, which met on February
15, 2005, to review these findings, FDA will require labeling changes for
Elidel and Protopic, including the placement of a boxed warning about the
potential cancer risk. In addition, FDA will work with the commercial sponsors
of the drugs to develop and implement a Medication Guide (MedGuide) to provide
this information and instructions about appropriate use of Elidel and Protopic
to patients, their families, and caregivers. MedGuides are intended to be
distributed by pharmacists with each prescription or refill of a medication.
Date
created: March 10, 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 
