The pain medication Bextra has been voluntarily withdrawn from the market by its manufacturer, Pfizer. Also, U.S. drug regulators will require all prescription nonsteroidal anti-inflammatory drugs, including Celebrex, to carry a "black box" warning about increased cardiovascular and gastrointestinal risks. A black box warning is the strongest warning that can be issued.

In addition, the Food and Drug Administration (FDA) will require label changes for all over-the-counter nonsteroidal anti-inflammatory drugs (NSAIDs), including naproxen and ibuprofen, to include expanded information about potential risks of:

• Cardiovascular (CV) events, such as heart attack and stroke
• Gastrointestinal bleeding
• Rare but serious skin reactions from using such drugs

These label changes don't apply to aspirin or acetaminophen.

The FDA cited the following reasons for its request to voluntarily withdraw Bextra:

• Lack of sufficient data on the cardiovascular safety of long-term use of Bextra, along with increased risk of adverse CV events, possibly associated with chronic Bextra use
• Reports of rare but serious, potentially life-threatening, skin reactions — Stevens-Johnson syndrome and toxic epidermal necrolysis — in people taking Bextra
• Lack of any demonstrated advantages for Bextra, compared with other NSAIDs

Long-term controlled clinical trials evaluating cardiovascular risk haven't been done with most NSAIDs affected by the label changes. However, the available data suggest that the use of these drugs may increase CV risk. The FDA has asked the manufacturers of these drugs to conduct comprehensive reviews and analyses of available research to further evaluate the potential for increased CV risk.

If you take Bextra, discuss alternative treatments with your doctor. If you have concerns or questions about taking other types of NSAIDs, consult with your doctor.