FDA issues safety warning for Agios, Celgene's Idhifa

FDA issued a warning to healthcare professionals and patients that signs or symptoms of differentiation syndrome, a life-threatening side effect of acute myelogenous leukemia drug Idhifa enasidenib, are not being recognized in some patients receiving Idhifa. Celgene Corp. (NASDAQ:CELG) and Agios Pharmaceuticals Inc. (NASDAQ:AGIO) market Idhifa in the U.S.

While FDA included a boxed warning of differentiation syndrome on Idhifa's label upon approval in 2017, the agency said it has become aware of cases where the syndrome failed to be recognized. Between May and July this year, a manufacturer safety report revealed five deaths in Idhifa patients associated with the side effect...