USA. The US 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. Females have a 3-fold higher risk of symptomatic liver toxicity than males, and females with CD4+ cell counts > 250 cells/mm3 have a 12-fold higher risk of symptomatic liver toxicity than females with CD4+ cell counts < 250 cells/mm3. 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.

Reference:

FDA Public Health Advisory for Nevirapine, 20 January 2005. Available on the Internet at www.fda.gov