On Wednesday, Johnson & Johnson’s Tibotec Therapeutics unit announced an update on the safety of its anti-HIV drug Intelence (etravirine). In cooperation with the U.S. Food and Drug Administration, the pharmaceutical company strengthened existing warnings and precautions regarding severe skin reactions.

The warning has been heightened due to postmarketing reports. One patient experienced a hypersensitive reaction accompanied by liver failure, but recovered. Another patient passed away as a result of toxic epidermal necrolysis, a condition in which the layers of the skin separate.

Tibotec additionally recommends that Intelence should be immediately discontinued if symptoms of severe skin reactions occur. These include, but are not limited to, severe rash or rash accompanied by fever, fatigue, muscle or joint aches, general malaise, oral lesions, conjunctivitis (commonly called “pink eye”), hepatitis, elevated levels of the white blood cell eosinophil, or facial swelling.

Tibotec has warned patients taking Intelence of skin reactions since the drug became available in January 2008. In clinical trials, the most frequently reported side effect was rash, experienced by 9 percent of patients. A total of 2 percent of subjects discontinued due to rash, and severe skin reactions were reported in 1 percent of participants.

For questions, further information on product safety, or to report adverse patient experiences, please contact Tibotec Therapeutics Medical Information at 1-877-REACH TT (1-877-732-2488).

For more information, please visit the Tibotec Therapeutics Web site (pdf).