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. Another patient taking the tablets reported a hypersensitivity reaction accompanied by liver failure.
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.
J&J’s Tibotec unit issued a letter to physicians about severe skin reactions and liver damage among patients taking the drug. The Food and Drug Administration has added information about the side effects to the drug’s labeling.
Intelence is a non-nucleoside reverse transcriptase inhibitor, or NNRTI, that blocks the enzyme HIV needs to multiply.
Tibotec Therapeutics is a division of Ortho Biotech Products LP, a Johnson & Johnson company based in Bridgewater, N.J.
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