Important note: Information in this article was accurate in 2001. The state of the art may have changed since the publication date.
Information Bulletin #13 May June 2001
The labeling that comes with Viramune (nevirapine), a widely used anti-HIV drug that belongs to the class of drugs called NNRTIs, has recently been changed to strengthen the warnings about possible risks of liver and other toxicities, due to reported cases of serious or fatal reactions to the drug. The new label says that people taking Viramune need to be on the look out for symptoms of liver problems such as fatigue, feeling sickly and weak, loss of appetite and nausea. There have been rare reports of these symptoms progressing to jaundice and liver failure over a period of just several days. People with any signs or symptoms of liver problems are advised to call their doctor immediately, stop taking all their anti-viral treatments, and get liver function tests done as soon as possible.
The label also says that the first 12 weeks on Viramune are especially important, since about two-thirds of the severe reactions that have been reported have happened in that period. The label notes that experts recommend getting lab tests done:
* before starting Viramune * two weeks after starting (before the dose is increased) * four weeks after starting * once a month for the next two months * "frequently" after the first three months (at least every 2-3 months)
If liver toxicity occurs, Viramune should be permanently stopped and not restarted after recovery. The new label notes that increased liver function tests and/or a history of chronic hepatitis (B or C) infection are associated with a greater risk of liver toxicity from Viramune. The label also recommends that the drug prednisone should not to be used to try and prevent Viramune-associated rash, as a clinical trial found that this made the problem worse.
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