Nevirapine®

The existing labeled warnings for the risk of hepatotoxicity with VIRAMUNE® (NevirapineŽ) treatment have been strengthened in response to continued reports of severe, life-threatening and in some cases, fatal hepatotoxicity that have been reported from clinical trials and post-marketing use with VIRAMUNE®.

Based on ongoing analyses of clinical trials and post-marketing safety data, Boehringer Ingelheim/Roxane Laboratories, Inc. have further characterized hepatic adverse events associated with VIRAMUNE®. In order to ensure that VIRAMUNE® is used safely and effectively, the Company has revised the product labeling to integrate new clinical data, strengthen warnings, and reinforce the need for careful clinical monitoring of patients during treatment.

Source: fda.gov

If you or a loved one has been harmed by Viramune, you may want to contact a Viramune attorney for more information.