Alerts
Etravirine (Intelence™): Severe Skin and Hypersensitivity Reactions
September 3, 2009
In post-marketing reports, etravirine was associated with potentially life threatening skin reactions including toxic epidermal necrolysis and hypersensitivity reactions that can present with a severe rash and liver failure. Tibotec Therapeutics, in agreement with FDA, has changed the Warnings and Precautions section of the etravirine package insert to reflect these post-marketing reports.
Discontinue etravirine at any sign of skin or hypersensitivity reaction. More information is available at the following links.
- MedWatch Safety Summary:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm180579.htm - Dear Healthcare Provider Letter:
http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/UCM180594.pdf
Updated
September 3, 2009; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
