FDA warns on Novartis, Fujisawa skin drugs

The FDA public health advisory has advised healthcare professionals to prescribe Elidel (pimecrolimus) and Protopic (tacrolimus) only as directed and only after other eczema treatments have failed to work. In addition, the FDA is adding a black box warning to the health professional label for the two products and is developing a medication guide for patients.

These actions follow the recommendations made by the FDA’s Pediatric Advisory Committee during its February 15 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.

Although the FDA’s actions represent bad news for Novartis and Fujisawa, the news has been described by competitor AvVaa World Health Care Products as a “watershed event.” AvVaa markets the only non-toxic, all-natural over-the-counter eczema treatment.