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J&J Unit Warns of Deadly Skin Reaction With HIV Drug

Aug. 26 (Bloomberg) -- Johnson & Johnson warned doctors of reports of a deadly skin reaction and liver failure tied to its HIV medicine Intelence.

The skin condition called toxic epidermal necrolysis has killed one patient and injured another since Intelence was approved in January 2008, said Pamela Van Houten, a spokeswoman for J&J’s Tibotec unit, in a phone interview today. Another patient taking the tablets reported a hypersensitivity reaction accompanied by liver failure, she said.

The prescribing information for Intelence was revised to include these reports and a caution that doctors stop treatment immediately if patients develop severe skin reactions or hypersensitivity symptoms, according to a letter e-mailed today by the U.S. Food and Drug Administration. Similar side effects were seen in some study participants and have also been linked to other drugs for HIV, the virus that causes AIDS, Van Houten said.

“We’ll continue to monitor” patient reports, she said. “We’re sending out this letter to doctors. Our sales force will also be talking to health-care providers” about the risks.

J&J, the world’s biggest maker of health-care products, didn’t disclose sales of Intelence in its annual report. The drug and Prezista, an HIV medicine approved in 2006, may bring in a combined $714 million in sales this year for the New Brunswick, New Jersey-based company, according to Glenn Novarro, an analyst with RBC Capital Markets in New York.

http://www.bloomberg.com/apps/news?pid=20601087&sid=ahjKmd78THj8