FDA Warns About Cancer Risks of Elidel, Protopic for Eczema

The FDA has issued a public health warning about the potential cancer risks of two eczema drugs -- Novartis Pharmaceutical's Elidel and Fujisawa Healthcare's Protopic.

In a recent Talk Paper, the FDA advised healthcare professionals to use the products only as directed and only after other eczema treatments have failed to work. The FDA also announced it was adding a black-box warning to the drugs' health professional label and is developing a Medication Guide for patients.

The FDA's actions follow the recommendations of a Feb. 15 Pediatric Advisory Committee meeting, which discussed the potential cancer risk for pediatric patients treated for atopic dermatitis with topical dermatological immunosuppressants.

The FDA reviewed cancer findings in three different animal species, the agency said. The data also included a small number of reports of cancers in children and adults treated with Elidel (pimecrolimus) and Protopic (tacrolimus), the FDA added.

For more information, go to http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01343.html (http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01343.html).