Pharmaceutical News and Articles

Viramune (nevirapine)

January 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]

Latest FDA MedWatch Alerts...

FDA MedWatch Alerts Archive

2009: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov
2008: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2007: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2006: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2005: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2004: Jan | Feb | Mar | Apr | May | Jun | Aug | Sep | Oct | Nov | Dec
2003: Jan | Feb | Apr | May | Jul | Aug | Sep | Oct | Nov | Dec
2002: Feb | Mar | Apr | May | Jun | Jul | Sep | Oct | Nov

MedNotes
Advertisement

(web4)