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U.S. Department of Health and Human Services


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Viramune (nevirapine) Feb 2004

Audience: Infectious disease and other healthcare professionals

Boehringer Ingelheim and FDA notified healthcare professionals of new safety information added to the WARNINGS and Boxed Warning for VIRAMUNE. Severe, life-threatening, and in some cases fatal hepatotoxicity, including fulminant and cholestatic hepatitis, hepatic necrosis and hepatic failure, has been reported in patients treated with VIRAMUNE. These events are often associated with rash. Women, and patients with higher CD4 counts, are at increased risk of these hepatic events. 

Women with CD4 counts >250 cells/mm3, including pregnant women receiving chronic treatment for HIV infection, are at considerably higher risk of these events. Prodromal signs and symptoms, risk information and monitoring recommendations have been added to the labeling.   

[February 2004 - Letter - Boehringer Ingelheim]
[January 2004 - Guidelines: Management of Rash/Hepatic Events with Viramune - Boehringer Ingelheim]