Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The FDA’s post-market safety review has uncovered a link between lenalidomide (marketed as the drug Revlimid) and serious skin reactions, including Stevens Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).

The FDA approved Celgene Corp.’s Revlimid in December 2005 to treat a bone marrow disorder. It was later approved for use in treatment of multiple myeloma, a type of blood cancer. Earlier this month, Revlimid appeared on a list of approximately twenty drugs under investigation by the FDA for possible safety hazards. No details about the specific concerns were made available at that time.

From the drug’s approved use in 2005 to January 23, 2008, the FDA received 14 reports of serious skin reactions following Revlimid therapy. Three deaths occurred among the 14 patients who displayed either SJS or TEN, although progression of cancer is suspected in one of the fatalities.

The estimated incidence of SJS/TEN is 1 to 2 persons per million annually. According to Brian Gill, a spokesman for the manufacturer of Revlimid, approximately 60 thousand people have been treated with the drug. Individuals with SJS normally have 10-30 percent of their body surface area affected by the disorder. SJS-related mortality is estimated to be between 1-3%. People with TEN normally suffer an infliction of more than 30% of their body’s surface area. Mortality ranges anywhere from 10-70%, according to the FDA.

Revlimid currently comes with warnings of other serious hazards, including birth defects and blood clots and is distributed, sold, and used with great restriction. The drug’s labeling will be updated to include reports of skin reactions and doctors are strongly advised to discontinue use in patients that develop skin irritations while taking Revlimid.

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