crimfunk

Celgene Becomes a Bargain Once Again

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WASHINGTON (Dow Jones)--The Food and Drug Administration said Thursday that Celgene Corp.'s (CELG) blood-cancer drug Revlimid may cause a rare but serious skin reaction in some patients.

The agency released a post-marketing review of Revlimid as part of a quarterly drug-safety newsletter that was posted to the agency's Web site. The review discussed 14 reports of serious skin reactions possibly linked to the drug.

Earlier this month, Revlimid appeared on a list of about 20 drugs that the FDA said it was investigating after receiving reports of various post-marketing safety issues but details weren't released.

The FDA said doctors need to be aware of the possibility that Revlimid could cause serious skin reactions and said the drug should be discontinued if a skin rash appears. The skin-reaction possibility is not currently contained in Revlimid's label, which partly serves as tool to warn doctors about drug risks, the FDA said.

Brian Gill, a spokesman for the Summit, N.J., company, said it was likely that the label for Revlimid would be updated to include reports of the skin reactions. He said about 60,000 patients have been treated with Revlimid.

Revlimid was approved in December 2005 to treat a bone-marrow disorder known as myelodysplastic syndromes and later approved for multiple myeloma, a type of blood cancer.

Since approval, the FDA said it had received 14 reports of serious skin reactions, known as Stevens-Johnson syndrome or toxic epidermal necrolysis, through January 2008. The agency said it received three reports of deaths in patients with the skin conditions, although in one case the cause of death was listed as progression of a type of blood cancer.

The skin conditions are two related skin disorders characterized by blisters that typically result from drug exposure. The agency said eight of the patients had reported either taking or previously being on other drugs that could have also caused the skin reactions. However, the FDA said in at least two cases it appeared that Revlimid played a role in the development of skin reaction.

Revlimid already carries the FDA's toughest black-box drug warning discussing the possibility of birth defects and other serious problems, such as blood clots, and is sold under a restricted distribution system.