Bextra®, generic name Valdecoxib, is a prescription COX-2 selective non-steroidal anti-inflammatory drug (NSAID) manufactured by Pfizer, Inc. On April 7, 2005, the Federal Drug & Food Administration (FDA) asked Pfizer to suspend sales of Bextra and to withdraw the drug from all markets due to adverse Bextra side effects. Pfizer, Inc. immediately halted all sales in the United States and Europe.

The FDA convened a public advisory committee meeting in February 2005 to review the cardiovascular safety of all COX-2 inhibitors and related drugs. The results of the meeting of the Center for Drug Evaluation and Research (CDER) were released in April 2005.

The agency concluded that the overall risk versus benefit profile for Bextra was unfavorable. It was at that time that the FDA requested that Pfizer, the manufacturer of Bextra, to remove the drug from the market. The request was based on the following:

• There was not enough adequate data on the cardiovascular (CV) safety of long-term use of Bextra, along with the increased risk of adverse cardiovascular events in short-term coronary artery bypass surgery (CABG) trials that FDA believes may be relevant to chronic use.
• Numerous reports from individuals (more than 7) of serious and potentially life-threatening skin reactions, including deaths, were linked to patients who used Bextra. The risks of these unpredictable reactions in individual patients occurred in patients both with and without prior histories of sulfa allergies. These adverse reactions were found in patients after short term and long-term usage.
• Lack of any demonstrated advantages in taking Bextra compared with other non-steroidal anti-inflammatory drugs.

At the time of the request for the removal of Bextra from the market, the FDA also issued request letters to all manufacturers of non-steroidal anti-inflammatory drugs (NSAIDs). The request included strong labeling changes to their products that are called “black box warnings”. A black box warning is the strongest warning the FDA issues. These letters included recommended labeling changes for both prescription and over-the-counter (OTC) NSAIDs and the inclusion of a special medication guide (package insert) for the entire class of prescription products. The package insert must include a warning that highlights the potential for increased risk of cardiovascular (CV) events and information on serious, potential life threatening gastrointestinal (GI) bleeding associated with the use of Bextra

In making the above decisions, the Center for Drug Evaluation and Research (CDER) considered the risk/benefit profile for each drug. The COX-2 and NSAID drugs permitted to remain on the market with the new warnings were allowed to continue to be marketed because it was determined that the benefits of the medications outweigh their risks.

When Pfizer agreed to suspend sales and marketing of Bextra the company requested that the panel consider a future further review of Bextra. This has not occurred, and reports indicate the agency may not agree to the company’s request for re-marketing Bextra. With the recent FDA decision to remove Bextra from the market, hundreds of lawsuits have already been filed on behalf of Bextra users. Any individual that believes that they may have been damaged in any way from using Bextra should consult an attorney.

It is recommended that patients who were taking Bextra contact their physician to consider alternative treatments. Any individual that believes they may have been harmed or suffered adverse heath effects from the usage of Bextra should seek the advice of an attorney who specializes in this type of litigation.