FDA MedWatch-Viramune [nevirapine] Public Health Advisory issued with indications and

[Brian, ASN, RN]

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

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.

Read the complete MedWatch 2005 safety summary, including links to the FDA Public Health Advisory, at

http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#viramune