FDA clarifies Revlimid safety signals

FDA published a Drug Safety Newsletter that included a post-market safety review of Revlimid lenalidomide from Celgene (NASDAQ:CELG) identifying 14 reports of serious skin reactions, including six hospitalizations and three deaths, between December 2005 and Jan. 23, 2008. The reactions included Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and erythema multiforme. Two patients died from progression of multiple myeloma (MM); the cause of the third death was not provided. Earlier this month, FDA said it was reviewing the thalidomide analog for a potential association with SJS adverse events (See BioCentury, Sep. 08, 2008).

Revlimid is approved in the U.S. to treat myelodysplastic syndromes (MDS) with 5q chromosomal deletion and MM. The product's label does not include warning language about the risk of serious skin reactions. SJS and TEN are included as precautions on the label for Thalomid thalidomide, Revlimid's parent compound that is marketed for MM and leprosy. ...