AR-News: (US)FDA MedWatch - Viramune (nevirapine) BOXED WARNING revised

[Masako Miyaji]

Date: Mon, 2 Feb 2004 16:23:56 -0500
From: CDER MEDWATCH LISTSERV
<MEDWATCHLIST at CDER.FDA.GOV>
Subject: FDA MedWatch - Viramune (nevirapine) BOXED
WARNING revised to report new hepatotoxicity 
 
MedWatch - The FDA Safety Information and Adverse
Event Reporting Program

Boehringer Ingelheim and FDA notified healthcare
professionals of new safety information added to the
WARNINGS and Boxed Warning for Viramune (nevirapine).
Severe, life-threatening, and in some cases fatal
hepatotoxicity, including fulminant and cholestatic
hepatitis, hepatic necrosis and hepatic failure, has
been reported in patients treated with Viramune. These
events are often associated with rash. Women, and
patients with higher CD4 counts, are at increased risk
of these hepatic events. Women with CD4 counts >250
cells/mm3, including pregnant women receiving chronic
treatment for HIV infection, are at considerably
higher risk of these events. Prodromal signs and
symptoms, risk information and monitoring
recommendations have been added to the labeling.

Read the MedWatch 2004 safety summary, including links
to the "Dear Healthcare Professional" letter and
revised label, at:
 
http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#viramune


__________________________________
Do you Yahoo!?
Yahoo! SiteBuilder - Free web site building tool. Try it!
http://webhosting.yahoo.com/ps/sb/