ROCKVILLE, Md. The Food and Drug Administration has notified healthcare professionals and patients of a change to the labeling of an HIV drug amid reports of adverse side effects.
The agency announced changes to the labeling of Tibotec Therapeutics drug Intelence (etravirine), citing reports of Stevens-Johnson syndrome, a severe skin disease that causes rashes and blisters, toxic epidermal necrolysis and erythema multiforme, an allergic reaction.
The FDA approved Intelence tablets in 2008. Tibotec is a division of Centocor Ortho Biotech Products, itself a division of Johnson & Johnson.