FDA MedWatch

Intelence (etravirine):Reports of severe, potentially life-threatening and fatal skin reactions

Intelence (etravirine)

Audience - Infectious Disease healthcare professionals, patients

08/27/2009 - Tibotec Therapeutics and FDA notified healthcare professionals of revisions to the WARNINGS AND PRECAUTIONS section of the prescribing information for Intelence (etravirine). There have been postmarketing reports of cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme, as well as hypersensitivity reactions characterized by rash, constitutional findings, and sometimes organ dysfunction, including hepatic failure. Intelence therapy should be immediately discontinued when signs and symptoms of severe skin or hypersensitivity reactions develop.

Read the complete MedWatch 2009 Safety Summary, including a link to the Dear healthcare professional letter, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/
SafetyAlertsforHumanMedicalProducts/ucm180579.htm