Celgene's big-selling blood cancer drug Revlimid may cause a rare but potentially fatal skin reaction in some patients, the FDA said. According to a post-marketing review of the drug, there have been 14 reports of Stevens-Johnson syndrome and a more severe form, toxic epidermal necrolysis, a skin flare-up that can lead to organ failure and serious infections. Those 14 cases included three deaths, though in one case, the cause of death was attributed to the patient's cancer.
The skin reaction isn't now listed among possible side effects on Revlimid's label, but Celgene said the label would likely be updated to reflect the case reports. The FDA warned that doctors should be on the alert for symptoms and discontinue the drug if a rash appears. According to the company, 60,000 patients have been treated with Revlimid since it was approved in 2005.
ALSO: In other safety news, Covidien warned that its injectable drug Phosphocol might boost the risk of leukemia. In a "Dear Doctor" letter, the company said that two children developed leukemia after receiving the drug as a hemophilia treatment. That's an off-label use; Phosphocol is approved to treat cancer patients for excess fluid in the lungs and chest. The company and the FDA said Phosphocol's label has been updated accordingly. Letter (.pdf)