Bextra, the trade name of the generic drug valdecoxib, was approved by the U.S. Food and Drug Administration (FDA) on November 16, 2001. Bextra came on the market with the intention to relieve symptoms of osteoarthritis and rheumatoid arthritis in adults and to relieve painful menstrual cycles for women. On April 7, 2005, the Food and Drug Administration (FDA) announced that it had asked Pfizer, Inc., the maker of the drug, to voluntarily withdraw Bextra from the U.S. market. Bextra had been linked to heart attacks, strokes, toxic epidermal necrolysis, and a potentially fatal skin condition called Stevens Johnson Syndrome.

Pfizer agreed to suspend sales and marketing of Bextra in the U.S., pending further discussions with the FDA.

In information that was provided to healthcare professionals, the FDA stated the following:

The overall risk versus benefit profile of Bextra is unfavorable. This conclusion is based on the potential increased risk for serious cardiovascular (CV) adverse events, which appears to be a class effect of non-steroidal anti-inflammatory drugs (NSAIDs) (excluding aspirin), an increased risk of serious skin reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme) compared to other NSAIDs, and the fact that Bextra has not been shown to offer any unique advantages over the other available NSAIDs.

Bextra was one of the first drugs classified as selective COX-2 inhibitors that has been approved by the U.S. Food and Drug Administration.

COX-2 inhibitors work by limiting the formation of inflammation, which is a common component of many forms of back pain and neck pain. Bextra is commonly prescribed by physicians for arthritis pain (i.e. osteoarthritis) and different types of pain associated with swelling.

Bextra works by preventing the formation of "inflammatory" prostaglandins. These compounds are produced by the enzyme "cyclooxygenase 2," commonly referred to as "Cox-2," and are believed to cause pain and inflammation, as well as prevent blood cells from sticking together. Unlike other NSAIDs, Bextra does not also block a second enzyme, commonly called "Cox-1," which monitors and maintains stomach tissue. Since this enzyme protects the stomach lining, Bextra has been promoted as being able to reduce pain and inflammation without also causing ulcers and gastrointestinal bleeding, but unfortunately, it has brought about many other tragic health conditions.

Millions of people who trusted Bextra now are forced to live in fear, anxiety, and pain because of the sometimes catastrophic consequences that their medication has now been known to cause. If you've suffered from these kinds of dangerous and potentially fatal side effects, you have a right to seek compensation.

Khorrami Pollard & Abir, LLP, is currently prosecuting individual and class action cases involving Celebrex.

For further information and a free consultation, please contact us either electronically or by telephone.

View the FDA's information page on COX-2 & Non-Selective Non-Steroidal Anti-Inflammatory Drugs