Elidel and Protopic receive black box warnings
Posted Jan. 24, 2006
On Thursday, Jan. 19, 2006, the U.S. Food and Drug Administration (FDA) required the labels of two prescription topical creams, Protopic (generic name tacrolimus) and Elidel (generic name pimecrolimus) to carry black box warnings of possible cancer risks. The new labeling will state that these medications should be used only after other prescription topical medications have been tried by patients.
While approved for eczema, Protopic and Elidel are often prescribed off-label for treating psoriasis on the face or other sensitive areas. Both drugs are topical immunosuppressants that reduce skin inflammation similar to topical steroids, but do not cause thinning of the skin.
Novartis Pharmaceuticals, maker of Elidel, and Astellas Pharma, Inc., maker of Protopic, dispute whether there is a cancer link. As of October 2005, the FDA has received reports of 78 cases of cancer in patients treated with the drugs. The manufacturers estimate that approximately 10 million people combined have used the two drugs.
The long-term side effects of Protopic and Elidel are unknown and it may take years to know the results of long-term safety studies.
The National Psoriasis Foundation encourages all patients to work with their doctor to create a treatment regimen that is safe and effective.
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