Tibotec, FDA Update Warning Label On HIV Drug’s Risk Of Severe Skin Reaction
Tibotec Therapeutics, a unit of Johnson & Johnson, "has strengthened a warning about serious skin reactions in patients treated with the company's HIV drug Intelence," the FDA and the company said on Wednesday, Reuters reports. Intelence has included a warning about the risk of severe skin reactions since its approval in January 2008, according to Pamela Van Houten, a spokesperson for Tibotec (Richwine, 8/26). "The skin condition called toxic epidermal necrolysis has killed one patient and injured another since Intelence was approved. ... Another patient taking the tablets reported a hypersensitivity reaction accompanied by liver failure, [Van Houten] said," Bloomberg reports (Larkin, 8/26). According to the Associated Press/Los Angeles Times, "The new label warns physicians to discontinue use of the drug if patients develop rash, fever, fatigue and other signs of an adverse reaction" (8/26).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.