Video originally created by FDA -- posted by Lawsuit.com on December 10, 2009

Tibotec Therapeutics is notifying healthcare professionals of severe and potentially life-threatening skin reactions from Intelence (etravirine), an antiretroviral drug used in HIV combination therapy. Intelence has been associated with cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme. Hypersensitivity reactions have also been reported, sometimes leading to organ dysfunction, including liver failure.

New labeling for Intelence warns that the drug must be discontinued immediately if severe skin or hypersensitivity reactions develop. Signs include severe rash, malaise, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, hepatitis and eosinophilia. The labeling cautions practitioners that a delay in stopping treatment after the onset of a severe rash may result in a life-threatening reaction.