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

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

For additional information about Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and other medications that may cause these conditions visit http://www.stevens-johnson-syndrome.com

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  • 8/28/2009 12:57 PM gary caldwell wrote:
    about may I started getting avery sever rash that formed into open wounds and such. I went to the doctor and got some salve and I am doing alpha lipoic pills. It has been about three months and has gotten better but is still red and itches. ty I asked if it wa stevens johonson syndrome and he said no
    Reply to this
  • 9/3/2009 2:51 AM Dentist San Jose wrote:
    This is a very informative post. Thanks for sharing this.
    Reply to this

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