J&J and FDA issue warning to doctors about reports of dangerous skin reactions with HIV drug

August 26th, 2009

J&J warns of allergic reactions with HIV drug

WASHINGTON — Johnson & Johnson has warned doctors about reports of potentially deadly allergic reactions in patients taking its HIV drug Intelence.

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.

Filed under FDA, HIV, News


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