FDA Warning on COX-2 Inhibitors & NSAIDS

Posted: May 1, 2005

On Thursday, April 7, 2005, the U.S. Food and Drug Administration (FDA) announced that it has asked Pfizer Inc. to voluntarily withdraw Bextra (valdecoxib) from the market and strengthen warning labels regarding the risk of serious cardiovascular events and gastrointestinal bleeding from COX-2 and non-selective non-steroidal anti-inflammatory drugs (NSAIDs).

The decision regarding Bextra stems from the limited data available on the long-term safety of the drug as well as recent reports of cardiovascular complications and potentially life-threatening skin reactions from the drug.

The Arthritis Foundation advises that people with arthritis work with their doctor to better understand the full range of treatment options and to develop a treatment plan that is best suited for their individual situation.

COX-2 inhibitors
The Arthritis Foundation recommends that people considering or taking COX-2 inhibitors discuss the topic with their doctor.

“The Arthritis Foundation believes the FDA decision helps to better inform people with arthritis about the potential risks associated with these drugs,” said John H. Klippel, M.D., president and CEO of the Arthritis Foundation. “This class of drugs is important for both pain relief and improvement of joint function for people with arthritis, and the decision will allow patients to be better informed about both the benefits and risks of these drugs.

“We also are pleased that the FDA has called for additional clinical studies to learn more about the long-term benefit and safety of these drugs in arthritis,” Dr. Klippel added.

NSAIDs
“Non-steroidal anti-inflammatory drugs continue to play an important role in the management of arthritis pain,” he said. “Patients who derive benefit from these drugs should remain on their treatment regimen, and discuss concerns with their physicians."

Over-the-counter NSAIDs include ibuprofen and naproxen. A complete list of products is available on the Internet at http://www.fda.gov/cder/drug/infopage/cox2/default.htm

The Arthritis Foundation stresses the importance of weight control and exercise, drug therapy and surgical options for the management of pain and functional limitations caused by arthritis.

Source: Arthritis Foundation

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