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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:
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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.
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Protopic Information
Elidel Information
Date created: March 10, 2005 |
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