On October 15, 2009, Tibotec, a division of Janssen-Ortho Inc., in collaboration with Health Canada, issued a Dear Healthcare Professional letter to relay important safety information for Intelence (etravirine). The letter strengthens warnings and precautions for severe skin reactions to reflect post-marketing reports of:
- a fatality due to toxic epidermal necrolysis
- hypersensitivity reactions, sometimes accompanied by hepatic failure
Intelence should be discontinued immediately if signs or symptoms of severe skin rash or hypersensitivity reactions occur. Clinical status and liver transaminases should be monitored and treated appropriately. Delays in discontinuing Intelence treatment after the appearance of a severe rash or hypersensitivity reaction may lead to a life-threatening reaction.
For more information: Click here to download the Warning letter issued by Tibotec