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U.S. Department of Health and Human Services

Safety

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Viramune (nevirapine) Jan 2005

Audience: Infectious disease and other 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 - Label - Boehringer Ingelheim]