Public Health Advisory Non-Steroidal Anti-Inflammatory Drug Products (NSAIDS)

December 23, 2004

The FDA is issuing a public health advisory concerning use of non-steroidal anti-inflammatory drug products (NSAIDS) including those known as COX-2 selective agents.

Recently released data from controlled clinical trials showing that the COX-2 selective agents (Vioxx, Celebrex, and Bextra) may be associated with an increased risk of serious cardiovascular events (heart attack and stroke) especially when they are used for long periods of time or in very high risk settings (immediately after heart surgery).

Preliminary results from a long-term clinical trial (up to three years) suggest that long term use of a non-selective NSAID, naproxen (sold as Aleve, Naprosyn and other trade name and generic products), may be associated with an increased cardiovascular (CV) risk compared to placebo.

While the results of these studies are preliminary and conflict with other study data on the same drugs, FDA is providing this advisory as an interim measure, pending further review of data that continue to be collected. Specifically:

• Physicians prescribing Celebrex (celecoxib) or Bextra (valdecoxib), should consider this emerging information when weighing the benefits against risks for individual patients. Patients who are at a high risk of gastrointestinal (GI) bleeding, have a history of intolerance to non-selective NSAIDs, or are not doing well on non-selective NSAIDs may be appropriate candidates for COX-2 selective agents.
• Individual patient risk for cardiovascular events and other risks commonly associated with NSAIDs should be taken into account for each prescribing situation.
• Consumers are advised that all over-the-counter (OTC) pain medications, including NSAIDs, should be used in strict accordance with the label directions. If use of an OTC NSAID is needed for longer than ten days, a physician should be consulted.

Non-selective NSAIDs are widely used in both over-the-counter (OTC) and prescription settings. As prescription drugs, many are approved for short-term use in the treatment of pain and primary dysmenorrhea (menstrual discomfort), and for longer-term use to treat the signs and symptoms of osteoarthritis and rheumatoid arthritis. FDA has previously posted extensive NSAID medication information at http://www.fda.gov/cder/drug/analgesics/default.htm.

FDA will be analyzing all available information from the new studies of Vioxx, Celebrex, Bextra, and naproxen, and other data for non-selective NSAIDs and COX-2 selective products to determine whether additional regulatory action is needed. An advisory committee meeting is planned for February 2005 which will provide for a full discussion of these issues.

Weitz & Luxenberg is no longer accepting Bextra cases.

see also:

Bextra Warning Letter on Skin Bextra Litigation - Bextra Lawyers - Bextra Warning Letter on Skin Reactions
On November 1, 2002, the department of health and human services officially warned Pharmacia of the dangerous skin related side effects of its drug Bextra. Here is the official warning.

Public Health Advisory NSAID Products Cox-2 inhibitor Litigation - Vioxx, Bextra, Celebrex Lawers - FDA Public Health Advisory
Public Health Advisory Non-Steroidal Anti-Inflammatory Drug Products (NSAIDS)

Warnings Bextra Attorney - Bextra Warnings
Injured by Bextra? Your doctor can help, then contact your Bextra Attorney