US warns about risks of Boehringer AIDS drug
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.
The Food and Drug Administration said doctors should weigh the risks and benefits before prescribing Viramune, which also is known by the generic name 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.
The medicine is used in drug cocktails to suppress HIV, the virus that causes AIDS. In many countries, a single dose of the drug is given to pregnant women to prevent mother-to-child transmission of HIV.
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.
Boehringer Ingelheim is a privately held company based in Germany. A company spokeswoman could not immediately be reached for comment.
Revision date: June 21, 2011
Last revised: by Sebastian Scheller, MD, ScD