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:
- 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.
Protopic was approved in 2000 and Elidel in 2001 to treat eczema.
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