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First
Vioxx was removed from the market because of safety concerns. Now Bextra, the
same-genre prescription painkiller made by Pfizer, has also been found by a
study to pose an increased risk of heart attack and stroke among users.
The study, presented at a meeting of the
American Heart
Association recently, found that patients who took Bextra were more than
twice as likely to suffer heart attacks or stroke. The study included 5,930
patients, some taking Bextra and some given a placebo.
"This is a time bomb waiting to go off," Dr.
Garret A.FitzGerald, a University of Pennsylvania cardiologist and
pharmacologist, told The New York Times after presenting the study
data on Nov. 9. "The magnitude of the signal with Bextra is even higher
than what we saw in Vioxx.”
Merck & Co. removed Vioxx from the market Sept. 30,
2004. A deluge of lawsuits have followed by people who used the drug and
claim to have suffered severe heart attacks and stroke as a result. Many of
those lawsuits were filed for patients and their families by Kline &
Specter.
One expert, Dr. Curt Furberg, professor of public health
sciences at Wake Forest University School of Medicine, who helped conduct
the latest Bextra study, says Bextra presents the same dangers as Vioxx.
“Basically, we showed that Bextra is no different than Vioxx,”
he told the Times. “And Pfizer is trying to suppress that
information.”
Pfizer, the world’s largest drug maker, introduced
Bextra in the United States in 2001, two years after Vioxx hit the market.
Both are COX-2 inhibitor drugs as is Celebrex, also made by Pfizer. Both
Bextra and
Celebrex remain on the market, used largely by arthritis
sufferers.
The latest Bextra study, which pooled data from patients
who participated in a dozen trials, found 2.19 times the number of heart
attacks or strokes among patients given Bextra, a pain reliever used to
treat
osteoarthritis, adult rheumatoid arthritis and severe menstrual
cramps.
FitzGerald, one of the world’s leading experts on COX-2
drugs, said the latest study findings added to growing worries that all
COX-2 drugs may be problematic and should be used with great caution.
For it’s part, Pfizer is denying problems with Bextra
for arthritis patients, saying that the only patients who experienced heart
problems were those at very high risk for heart disease. Pfizer on Oct. 15
had warned doctors that studies showed Bextra might increase the risk of
heart attack or stroke in coronary bypass surgery patients. Those studies
were conducted only in certain high-risk surgical settings, according to
Pfizer.
The
company says that other studies involving 8,000 patients with arthritis
revealed no heart problems. But Pfizer plans further studies to determine
the long-term safety of Bextra.
News:
Kaiser
Permanente bans the use of Bextra
FDA position on Bextra
Vioxx - Celebrex - Bextra Panel Drug ties questioned
FDA asks Pfizer to withdraw Bextra from
the market - April 7, 2005
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