If one of these turned out to be just 2 percent better than the other at preventing heart attacks and deaths, this knowledge would save vast numbers of lives around the world, because heart attacks are so common, and because statins are so widely used.
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But that was before Vioxx (withdrawn because of heart attacks) and Ketek (severely restricted because of liver side effects) and a series of other controversies that resulted in FDA brass being called in front of Congress.
Curfman says the editors had assumed that the VIGOR manuscript only included limited data on heart attacks because that was all that was available at the time.
The differences in the risk of heart attack weren't, possibly because of the low incidence of heart attacks among people in the study, researchers said.
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He argues that because of the potential for heart attacks and other risks, including cases of heart failure and broken bones, Avandia should be yanked.
Glaxo has had a fair bit of bad publicity recently with the FDA restricting access to its Avandia diabetes drug because it seems to cause heart attacks.
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But when he saw that Scandanavian study, James Liao wasn't immediately convinced about the benefits of LDL. He was surprised, because Zocor not only prevented heart attacks but also strokes.
Patients in Japan who lacked the protein actually seemed to have an increased risk of heart attacks, because, although they had more HDL, it may not have worked as well.
Two years later, Merck decided to yank Vioxx from the market because it increased the risk of heart attacks and strokes.
Cholesterol-drug Zocor loses patent protection next year, and the painkiller Vioxx was withdrawn in September because it increased the risk of heart attacks and strokes.
Because Vioxx doubled the rate of heart attacks and strokes in patients with heart disease, some doctors are worrying about other drugs in the same class, called cox-2 inhibitors.
The licensing of medicine by America's Food and Drug Administration has become slower since 2004 when a pain-killer, Vioxx, was withdrawn by its maker, Merck, because it increased the risk of heart attacks and strokes.
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When Merck (nyse: MRK - news - people ) pulled Vioxx off the market because it increased the risk of heart attacks and strokes, it had stated that the company believed it would be possible to continue to market Vioxx with a strong warning label.
To Nissen, older users are particularly troubling because they are at higher risks of heart attacks and strokes.
But he says the Prove-It is plenty big enough, because researchers also counted the number of heart attacks, angiographies, and bypass surgeries--giving them more than 1, 000 events to use in comparing the two drugs.
In July Glaxo pled guilty to U.S. misdemeanor charges that it had marketed the anti-depressants Paxil and Wellbutrin for unapproved uses and had not disclosed clinical data related to the diabetes medicine Avandia, which eventually had its use severely restricted because it may increase the risk of heart attacks.
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Jack Kutner, one of Dr. Plutzky's patients, took a big dose of niacin each day for more than two decades in part because of his family's history of fatal heart attacks.
Merck reached a settlement with the American government over Vioxx, its blockbuster painkiller that was pulled from the market in 2004 because it was found to increase the risk of heart attacks and strokes.
Zelnorm, a Novartis drug for painful bowel symptoms, was pulled from the market because of another meta-analysis that showed an increased risk of heart attacks.
Off-label use of NovoSeven has previously raised concerns, partly because a drug that promotes formation of clots can increase risk of heart attacks and strokes.
Rival AstraZeneca said it had stopped its 15, 000-patient clinical trial of its Crestor because an independent safety committee said there was proof the drug prevents heart attacks, strokes and deaths.
Rival AstraZeneca (nyse: AZN - news - people ) said it had stopped its 15, 000-patient clinical trial of its Crestor because an independent safety committee said there was proof the drug prevents heart attacks, strokes and deaths.
She used to be a big prescriber of omega-3 fish oil, but has stopped because the failure of niacin, a drug that lowered triglycerides, to prevent heart attacks and strokes.
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But this may be less encouraging than it seems, because if vorapaxar increased the number of strokes due to bleeding, that could balance out any benefit from reducing heart attacks and strokes.
It also opened the possibility that when patients sued, saying their heart attacks were caused by Vioxx, Merck could ask to have the vast majority of cases tossed out because the plaintiffs didn't take Vioxx for very long.
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