Regulatory

US FDA warns about risks of Boehringer AIDS drug

Last Updated: 2005-01-19 17:06:27 -0400 (Reuters Health)

WASHINGTON (Reuters) - U.S. health officials on Wednesday warned the public they had received reports of liver toxicity and deaths related to Boehringer Ingelheim's AIDS drug, Viramune (nevirapine).

The Food and Drug Administration said doctors should weigh the risks and benefits before prescribing nevirapine.

"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.

Cases of liver damage that produce symptoms such as a rash, fever or other symptoms are more common with Viramune than with other HIV-fighting drugs, the FDA said. Some instances have been fatal.

No serious or fatal liver toxicity has been reported after a single Viramune dose, the FDA said. In many developing countries, a single dose of the drug is given to pregnant women to prevent mother-to-child transmission of HIV.

Boehringer Ingelheim is a privately held company based in Germany. A company spokeswoman could not immediately be reached for comment.