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In August 2009, Tibotec Therapeutics and the FDA issued a letter to healthcare providers, warning about the potential for severe skin and hypersensitivity reactions to etravirine. A risk for rash was evident in clinical trials of this drug (with 2% of recipients discontinuing participation because of it), but now there have been postmarketing reports of fatal toxic epidermal necrolysis and hypersensitivity reactions, sometimes with hepatic failure. Clinicians are being urged to stop etravirine immediately in patients with signs or symptoms of severe skin or hypersensitivity reactions.