FDA "Black Box" Warning Placed on Two Eczema Drugs

By Elizabeth Rhein

Published on January 20, 2006

Although no definitive link has yet been made between the eczema treatments and skin disorders, the FDA is taking the cancer reports very seriously. Following an initial label change after an advisory committee meeting last year, the black box warning is intended to inform and caution both healthcare providers and their patients.

The new labeling will caution users of the increased risk of cancer and emphasize that the drugs should only be used if other eczema treatments fail.

The drugs' manufacturers, Novartis Pharmaceuticals (Elidel) and Astellas Pharma Inc. (Protopic), are complying with the FDA labeling request, though they believe that the government agency's actions are unfounded until further research proves a clear cancer link to the drugs.

If you are currently using either Protopic ointment or Elidel cream to treat eczema, you should speak with your medical provider before changing or discontinuing use.

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