Bextra
On April 7, 2005, Pfizer suspended all sales of the popular pain killer Bextra in the United States and the European Union after the Food and Drug Administration (FDA) announced that the overall risk versus benefit of Bextra is unfavorable.
The drug is made by Pfizer, the world's largest drug maker, which denies any problem exists with Bextra. However, in a statement on April 7, 2005, Pfizer stated that, "For now, patients should stop taking Bextra and contact their physicians about appropriate treatment options."
The decision to withdraw Bextra, from the market was based on an increase in adverse cardiovascular events shown in Bextra trials, reports of serious and potentially life-threatening skin reactions, including deaths, and lack of any demonstrated advantages for Bextra compared with other non-steroidal anti-inflammatory drugs (NSAIDs).
Bextra (Valdecoxib), may be linked to increased heart attack and stroke risks. Bextra is in the same class of drugs as Vioxx which was withdrawn after studies showed it was too dangerous. These drugs are both Cox 2 Inhibitors, a drug class that many researchers believe interferes with the body's natural ability to reduce blood clots, thereby increasing heart risks. Many doctors believe Bextra presents the same or similar risks as Vioxx.
In addition to being linked to an increase in heart attacks and strokes, Bextra is associated with a skin disorder called Stevens Johnson Syndrome or "SJS". Stevens Johnson Syndrome is a severe allergic reaction and is potentially life threatening.
A November 2004 study, presented to the American Heart Association indicates that patients who take Bextra are more than twice as likely (as non users) to suffer heart attacks or stroke. The study involved 5,930 patients, some taking Bextra and some given a placebo.
Dr. Garret A. Fitzgerald, the University of Pennsylvania cardiologist who presented the study to the AHA was quoted in The New York Times saying: "This is a time bomb waiting to go off.... The magnitude of the signal with Bextra is even higher than what we saw in Vioxx."
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