:: Health News ::

FDA recently advised health care professionals and patients about a potential cancer risk from two topical immunosuppressant products used to treat atopic dermatitis (eczema). The drugs are Elidel (pimecro-limus) and Protopic(tacro-limus).

The advisory cautioned that these products should be used only as directed and only after other eczema treatments have failed. FDA is also adding a boxed warning to the labeling for these two products and developing a Medication Guide for patients.

The concern about possible cancer risk is based on information from animal studies, on case reports in a small number of patients, and on the drugs’ mechanism of action. Long term human studies may be needed to determine whether Elidel or Protopic pose a cancer risk in humans, and the extent of the risk, if any. In the meantime, FDA has several recommendations to help minimize the risk.

First, use Elidel and Protopic only as second-line agents for treatment of eczema in patients who have failed or can’t tolerate other prescription treatments.

Use Elidel and Protopic only for short periods of time, not continuously. The long term safety of these drugs is unknown.

Use the minimum amount of Elidel or Protopic needed to control the patient’s signs and symptoms. In animals, increasing the dose resulted in higher rates of cancer.

Do not use these drugs in children and adults with a weakened or compromised immune system.

And finally, avoid using these drugs in children younger than 2 years of age. Elidel and Protopic are not approved for this use, and the effect of these drugs on the developing immune system in infants and children is not known.

Additional Information:

FDA MedWatch Safety Alert 2005 - Elidel (pimecrolimus)/Protopic (tacrolimus)
http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Elidel