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FDA Urges Expansion of Eczema Drug Warning Labels


The US Food and Drug Administration is considering expanding the warning labels of the Novartis AG cream Elidel (pimecrolimus) and AStellas Pharma’s Protopic (tacrolimus) used to treat eczema. The drugs already carry a strong warning, called a black box warning, about the increased risk of cancer in young children.

The documents, released a head of an FDA advisory meeting, are part of a conference to evaluate potential safety concerns with a variety of drugs used in younger patients.

The agency has received reports of 46 cancer cases and 71 infection cases in patients aged 16 and younger from 2004 to 2008 with these medications, called topical calcineurin inhibitors or TCI’s. They are the first non-steroid medications developed to treat eczema and work by suppressing the immune system, which is possibly one of the cancer-causing factors.

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The warning label for Protopic Ointment, required by the FDA since January 2006, reads “The safety of using Protopic, and drugs like it, for a long period of time is not known. A very small number of people who have used Protopic have had cancer (for example, skin or lymphoma). However a link with Protopic has not been shown.” The Elidel label has similar language.

The FDA also requires that other medications should have been attempted first to control moderate to severe eczema before using TCI’s and that the medications should not be used in children under the age of two. Both ointments also warn against using the medication for an extended period of time.

Protopic was approved by the FDA in December 2000, and Novartis estimates that 5.4 million patients worldwide have been treated with the ointment. Elidel was approved in 2001.

Professional societies of allergists and dermatologists do not support the stronger warning statements, as they say that the reason was not based on available scientific evidence specifically for the topical use of the creams. They say that the rate of cancer development occurring in people using Elidel and Protopic are actually below the rate expected in the general population.