FDA warns of liver risks linked to Viramune

The HIV antiretroviral drug Viramune can cause sometimes deadly liver damage but remains a key option for many patients, U.S. health officials warned on Wednesday. The Food and Drug Administration said doctors should weigh benefits and risks before prescribing the nonnucleoside reverse transcriptase inhibitor, manufactured by Boehringer Ingelheim. No serious liver toxicity or deaths have been reported when a single dose was given to prevent mother-to-child transmission of the deadly HIV virus that causes AIDS, the FDA said. Viramune, also known by its generic name nevirapine, is distributed for that use in African countries as part of President George Bush's effort to fight the spread of AIDS. The name-brand drug is also used in the United States. Controversy has swirled recently in Africa, with South Africa's ruling African National Congress accusing U.S. officials of conspiring with Boehringer Ingelheim, a private company based in Germany, to hide nevirapine's side effects. U.S. health officials dispute the charge. The FDA, in a statement, said cases of liver damage that produce a rash, fever, or other symptoms were more common with nevirapine than with other HIV-fighting drugs. Some instances have been fatal, including some in pregnant women. Females and patients with higher counts of infection-fighting CD4 immune system cells have greater risks of developing liver damage, the FDA said. The FDA said side-effect warnings had recently been revised on the drug's prescribing information. "In spite of the potential for serious and life-threatening liver toxicity and skin rashes with nevirapine, there are multiple reasons why nevirapine remains an important part of an HIV treatment regimen for many HIV-infected individuals worldwide," the FDA said in a statement. A spokeswoman for Boehringer Ingelheim said there would be no change in the company's policy of offering Viramune free of charge to developing countries for preventing mother-to-child transmissions of HIV. "There is no consequence for our donation or for supply of the drug for continuous treatment at reduced prices in developing countries," the spokeswoman said. "We do not expect any major effects on the behavior of doctors or on our sales as a result of the FDA warning." (Reuters)