In April 2005, the Federal Drug & Food Administration (FDA) asked Pfizer Inc. to suspend sales of Bextra. Pfizer halted the sales of Bextra because the FDA determined that the health risks associated with the drug outweighed the prescription's benefits. It has been estimated that 7 million patients were prescribed Bextra and that approximately 12.9 million prescriptions were written for Bextra in 2004. Bextra is a prescription COX-2 selective non-steroidal anti-inflammatory drug (NSAID).

Pfizer Inc. withdrew Bextra because of concerns that it caused increased heart attacks, strokes and a potentially fatal skin disease, Stevens Johnson Syndrome. At the time the FDA asked for Bextra’s removal the agency also said it would require tougher safety warnings on all NSAIDs, including the medications Celebrex, Mobic, Aleve and Motrin.

Bextra is in the same class of drugs as Merck & Co's drug Vioxx, the COX-2 inhibitor pain reliever whose withdrawal from the market in September 2004 started the analysis of patient signals that Vioxx, like Bextra, caused increased rates of heart attacks and strokes in some people who took the medication. Although Merck initiated its own Vioxx withdrawal, Pfizer withdrew Bextra from the market reluctantly and at the time voiced concerns that the FDA was changing how it judged the value of medications. Pfizer chose to respectfully disagree with FDA’s position regarding the overall risk/benefit profile of Bextra.

In May 2005, in response to media inquiries, Pfizer issued the following statement:

“As previously communicated, Pfizer has suspended sales of Bextra (valdecoxib) pending further discussions with the U.S. Food and Drug Administration (FDA). Pfizer continues to believe that Bextra could be an important treatment option for certain patient populations. In the future, the company plans to discuss options with the FDA under which Bextra might be made available to those patients. “

Upon further review, the FDA informed Pfizer that, in the agency’s view, Bextra’s cardiovascular (CV) risk could not be differentiated from other NSAIDs.  However, the agency concluded that the additional, increased risk of rare but serious skin reactions associated with Bextra (already described on its label) warranted its withdrawal from the market. These skin reactions included Stevens Johnson Syndrome, which is a rare, life-threatening reaction to medication – one of the most devastating of all adverse drug reactions.

Stevens Johnson Syndrome is characterized by inflammation of the mucous membranes of the mouth, throat, eyes, genital tract and intestinal tract. Ulcers inside the mouth are the most common, causing inflammation and irritation to the tongue, gums, and lips and can extend into the throat. Affected individuals may also have skin lesions, blisters and bleeding in the lips, eyes, mouth, nasal passage and genital areas. As SJS evolves, the skin literally sloughs off in sheets. Patients are typically treated in a hospital’s burn unit. If the skin lesions become infected, or the patient develops lesions in the lungs, it can cause death.

Bextra was originally prescribed to arthritis sufferers to relieve symptoms of osteoarthritis and rheumatoid arthritis. It was also prescribed to women in hopes of relieving PMS and painful menstrual cycles. A November 2004 study, presented to American Heart Association indicated that patients who took Bextra were more than twice as likely (as non-users) to suffer heart attacks or stroke. The study involved almost 6,000 patients, some who took Bextra and some who were given a placebo. To date, several COX-2 inhibitors have been banned due to the increased risk of stroke, heart attack, stomach ulcers, liver damage, and severe skin reactions among patients.

Some classes of patients were always at a higher risk of side effects and complications when taking Bextra. This includes patients immediately post-operative from cardiovascular bypass surgery (CABG) and people who had coronary artery disease (people who have known angina or who have had a heart attack), people who had cerebrovascular disease, people who have had a stroke or who currently have episodes known as TIA (transient ischemic attacks), and people with a history of stomach ulcers. It has been suggested that patients in these classes who were prescribed Bextra should consult with a specialist even if they did not have any immediate adverse side effects.

If you or a family member has suffered serious side effects or a fatal injury such as a heart attack or stroke after using Bextra, you or the family member may be eligible to file a claim against the drug manufacturer. Contact an attorney to discuss your legal rights.