Intelence FDA Alerts
The FDA Alert(s) below may be specifically about Intelence or relate to a group or class of drugs which include Intelence (etravirine).
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.
Recent FDA Alert(s) for etravirine
Aug 27, 2009
Audience: Infectious disease healthcare professionals, patients
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.
[August 2009 - Dear Healthcare Professional Letter - Tibotec Therapeutics]