FDA Alert on Viramune Won't Impact Sales, Boehringer Says

German drugmaker Boehringer Ingelheim doesn't anticipate that a recent FDA health advisory for its HIV drug Viramune will have a major impact on the drug's sales or distribution.

The FDA recently issued a health advisory for Viramune (nevirapine) to inform healthcare providers and patients that the drug's label has been revised to indicate that it may cause liver damage in certain female populations. The revised label also includes a new medication guide that informs patients about risks associated with Viramune when used for the treatment of HIV.

Viramune's label has been changed numerous times during the past two years to include information on liver toxicity associated with long-term use of the drug. The FDA stated in its advisory that symptomatic liver toxicity is more common with Viramune than other antiretroviral drugs.

"We do not expect any major effects on the behavior of doctors or our sales as a result of the FDA warning," a Boehringer spokeswoman said. She added that the revised labeling is part of the company's ongoing efforts to inform patients about the risks associated with Viramune.

The spokeswoman also said that the FDA alert won't affect Boehringer's ongoing program that offers Viramune free of charge to developing countries for preventing mother-to-child transmission of HIV. Viramune is a component of a commonly used triple combination HIV cocktail that also consists of GlaxoSmithKline's Epivir (lamivudine) and Bristol-Myers Squibb's Zerit (stavudine).

To view the FDA health advisory, go to http://www.fda.gov/cder/drug/advisory/nevirapine.htm (http://www.fda.gov/cder/drug/advisory/nevirapine.htm).