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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Bextra is in the same class of drugs as Vioxx which was withdrawn after studies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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