U.S. Warns of Safety Risks of Boehringer AIDS Drug

An important AIDS drug 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 drug, Boehringer Ingelheim’s Viramune, also known by the generic name nevirapine.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.Nevirapine is distributed for that use in African countries as part of President Bush’s effort to fight the spread of AIDS. The 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 cells called CD4 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.Nevirapine is one of the medicines used in drug cocktails that can suppress the HIV virus and keep patients healthy. HIV patients have limited options for suppressing the fatal virus, and alternative drugs also have serious side effects, the agency said.”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 people),” the FDA said in a statement.A Boehringer spokeswoman could not immediately be reached for comment on Wednesday.The AIDS virus killed 2.3 million people in Africa in 2004.Nevirapine came under question recently when a scientist from the National Institutes of Health, who was fired but is contesting the dismissal, charged a study of the drug in Uganda was sloppily run.A committee of experts at the Institute of Medicine is reviewing the research to see if it was so flawed the data are useless.The NIH has said the allegations are false and endanger the lives of babies because people will be afraid to use a valuable drug.