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Cancer, Infections Reported in Kids Treated with Elidel, Protopic

Mar 19, 2010 | Parker Waichman LLP

Dozens of cancer cases and infections have been reported in children treated with the eczema drugs Elidel and Protopic. According to a report from Reuters, the Food & Drug Administration (FDA) may require the makers of these medications to expand their warning labels.

Elidel and Protopic are known as topical calcineurin inhibitors or TCI’s. They are the first non-steroid medications developed to treat eczema and work by suppressing the immune system. The immunosuppressant action could be a factor in the cancer and infection cases reported. Both drugs already carry a strong warning – a black box – about the increased risk of cancer in young children.

According to documents posted on the FDA Web site, Elidel and Protopic have been associated with 6 cancer cases and 71 infection cases in patients aged 16 and younger from 2004 to 2008. According to Reuters, the documents were released ahead of an FDA advisory meeting Monday to weigh potential safety concerns with a variety of drugs used in younger patients.

The current black box was added to the drug’s labels in 2006. The warning for Protopic 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 be attempted first to control moderate to severe eczema before using either Elidel or Protopic. The agency also says 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.

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