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FDA Alert - Elidel

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This morning we published an alert from the FDA regarding Protopic, an ointment used to treat common skin problems such as eczema. Another FDA alert regarding Elidel, a similar topical ointment, has been issued.

FDA ALERT [02/14/2005]: FDA is investigating postmarketing reports of lymphoma and skin cancer in children and adults treated with Elidel, but the causal relationship has not been clearly established.

We are continuing to analyze these reports to determine whether the occurrence of these adverse events affects the risk/benefit assessment of Elidel therapy. Elidel is not approved for use in pediatric patients less than 2 years of age.

This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.

More information is available at FDA Alert - Elidel