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