FDA'S COX-2 SAFETY MEETING SCHEDULED FOR FEBRUARY

The FDA's highly anticipated advisory committee meeting addressing the safety of Cox-2 inhibitors has been scheduled for Feb. 16-18.

The joint meeting of the FDA's Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee will examine the overall risk-benefit considerations -- including cardiovascular and gastrointestinal safety concerns -- for Cox-2 selective nonsteroidal anti-inflammatory drugs (NSAIDs) and related agents.

The panel meeting follows several recent high-profile announcements about cardiac risks associated with the popular painkillers, including Pfizer's Celebrex (celecoxib) and Merck's Vioxx (rofecoxib), which the firm pulled from the market in September 2004. The FDA also last month announced similar concerns about naproxen, a common OTC NSAID that is marketed by Bayer under the brand Aleve.

The FDA is not required to follow an advisory panel's recommendations, but it usually does. Background materials will be posted at least one day prior to the meeting. For more information on the meeting, go to http://www.fda.gov/oc/advisory/accalendar/2005/cder12532ddd0216171805.html (http://www.fda.gov/oc/advisory/accalendar/2005/cder12532ddd0216171805.html).