Important note: Information in this article was accurate in 2009. The state of the art may have changed since the publication date.
Associated Press - August 26, 2009
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.
The skin reactions included cases of Stevens-Johnson Syndrome, a life-threatening skin disorder that begins with fever, sore throat and fatigue. Some of the allergic reactions resulted in liver failure, according to the labeling.
The new label warns physicians to discontinue use of the drug if patients develop rash, fever, fatigue and other signs of an adverse reaction.
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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