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Viramune FDA Alerts

The FDA Alert(s) below may be specifically about Viramune or relate to a group or class of drugs which include Viramune (nevirapine).

MedWatch Safety Alerts are distributed by the FDA and published by Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for nevirapine

Viramune (nevirapine) - Jan 19, 2005

Jan 19, 2005

Audience: Infectious Disease healthcare professionals

FDA issued a public health advisory to inform health care providers and patients about recent safety-related changes to the nevirapine (Viramune®) label and about appropriate use of HIV triple combination therapy containing nevirapine, a treatment option in the United States which is increasingly being used globally. The Indications and Usage section now recommends against starting nevirapine treatment in women with CD4+cell counts greater than 250 cells/mm3 unless benefits clearly outweigh risks. This recommendation is based on a higher observed risk of serious liver toxicity in patients with higher CD4 cell counts prior to initiation of therapy. In addition, the revised label now includes a Medication Guide to inform patients about risks associated with nevirapine when used for the treatment of HIV.

[January 19, 2005 - FDA Public Health Advisory - FDA]
[January 2005 - Revised Label - Boehringer Ingelheim]
[January 2005 - Medication Guide - Boehringer Ingelheim]

Viramune (nevirapine) - Feb 2, 2004

Feb 2, 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]
[February 2004 Revised label - Boehringer Ingelheim]
[January 2004 Guidelines: Management of Rash/Hepatic Events with Viramune - Boehringer Ingelheim]

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