The Cartwright Law Firm is currently evaluating potential injury claims of individuals who have taken Bextra (valdecoxib) and have been diagnosed with a heart attack or stroke while taking that medication. If you or a loved one have taken Bextra and have suffered from a heart attack or stroke, please call immediately for a free, confidential consultation with one of our firm’s attorneys.

Developed by G.D. Searle & Co., acquired by the world’s largest pharmaceutical company, Pfizer, Inc., and approved by the U.S. Food and Drug Administration (FDA) on November 16, 2001, Bextra became the third Cox-2 Selective Non-Steroidal Anti-Inflammatory Drug (NSAID) to go on the market. On April 7, 2005, the FDA requested Pfizer to voluntarily remove Bextra from the market.

Bextra, also known as Valdecoxib, was approved for the treatment of symptoms of osteoarthritis and rheumatoid arthritis in adults as well as for the treatment of dysmenorrhea (painful menstrual cycles). Prior to its removal from the market Bextra was recommended to be prescribed in doses of 10mg and 20mg per day.

Like its predecessor Celebrex, manufactured by the same drug company, Pfizer, Inc., and Merck & Co.’s Vioxx, Bextra was a Cox-2 Selective NSAID. Also, like its fellow Cox-2 NSAIDs Celebrex and Vioxx, Bextra failed to provide any mention of potential cardiovascular risks in its promotional materials or actual package inserts provided with each Bextra prescription although such risks were known to the company. On November 13, 2002 Pfizer, Inc. provided a “Dear Healthcare Professional” letter the medical community to advise of recent changes to Bextra product labeling. However, these recent label changes all regarded hypersensitivity reactions (i.e., anaphylactic reactions) and skin reactions including Stevens-Johnson syndrome and others. It was not until December 2004, two years later, that Pfizer upgraded its warnings on the package label to include a warning about possible heart and blood clotting problems for individuals using Bextra, in particular for those taking Bextra following coronary artery bypass graft surgery.

In November 2004 a study was presented to the National Heart Association that indicated patients who used Bextra were more than twice as likely as those taking a placebo to suffer from heart attacks or strokes. The study involved at total of 5,930 patients, and was presented to The American Heart Association by Dr. Garret A. FitzGerald, a cardiologist at the University of Pennsylvania. Dr. FitzGerald was quoted in the New York Times as stating, “This is a time bomb waiting to go off . . . . The magnitude of the signal with Bextra is even higher than what we saw with Vioxx.”

The New England Journal of Medicine on December 23, 2004 published the article, “Cardiovascular Toxicity of Valdecoxib” (Bextra) by Drs. Wayne Ray, Marie Griffin and Michael Stein. Because of the results of this and other studies demonstrating the cardiovascular toxicity of Bextra, the authors concluded that “to protect the safety of the public, we write to recommend that clinicians stop prescribing valdecoxib (Bextra),” and that “we believe the doubts raised about the safety of Bextra constitute a potential imminent hazard to public health and thus require action.” This study included over 1500 patients who were treated with Bextra for pain after coronary artery bypass surgery. The study showed that patients who had taken Bextra were more likely to have adverse cardiovascular events such as myocardial infarction (heart attack), stroke, deep vein thrombosis and pulmonary embolism than placebo-treated patients. Pfizer chose to strengthen its Bextra warnings at this time to state that Bextra was unsafe for the treatment of pain immediately following coronary artery surgery.

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