The U.S. Food and Drug Administration (FDA) released a Public Health Advisory at 10:00 am Thursday, April 7, 2005, to warn the public that it has requested that Pfizer, Inc., manufacturer of the COX-2 inhibiting drug Bextra, voluntarily recall Bextra from the market. Pfizer has agreed to suspend sales and marketing of the drug, pending further discussions with the agency.

At the same time, the FDA is asking all manufacturers of prescription NSAIDs (non-steroidal anti-inflammatory drugs), including Celebrex, to revise the labeling and packaging of their products to include a “black-box” warning and a Medication Guide.

The boxed warning, highlighted with a black border and found at the top of pharmaceuticals known to have adverse effects in some patients, is considered to be the FDA’s strongest warning against use of a drug. The “black box” should highlight the potential for increased risk of cardiovascular events such as cardiac arrest, sudden cardiac death, and stroke, with the use of NSAIDs.

The warning should also continue to highlight well-known gastrointestinal side effects of NSAIDs that are also potentially life-threatening as well, such as stomach ulcers and bleeding.

The Bextra request was based on a continued lack of overall data on the cardiovascular safety of Bextra. The FDA states that there is an increased risk of adverse cardiovascular side effects with chronic use of Bextra in patients undergoing coronary artery bypass surgery.

Also cited were the increasing reports of adverse skin reactions in some patients on Bextra, including Stevens-Johnson Syndrome, a serious allergic reaction. Stevens-Johnson Syndrome is a form of allergic reaction usually caused by certain types of drugs. Symptoms usually begin as a blistering of the lips and mouth that spreads to the throat, tongue, and other parts of the body. The blisters sometimes become so extensive that they are fatal.