FDA (Food and Drug Administration) in United States recently issued a warning of increased risk of heart attacks on an anti-diabetes drug, Avandia, manufactured by the British company GlaxoSmithKline. The move has forced the manufacturer to agree on adding warning in the drug's labeling about potential increased risk for heart attacks, according to a statement issued by FDA on November 14, 2007.
Some 7 million people around the world has taken the drug and half of them are in the United States. This also generates some 3.3 billion dollars of annual global sales for Glaxo.
Why warning has been issued suddenly for such a popular drug?
Based on an analysis of some 42 short-term clinical studies, published In May 2007 in the New England Journal of Medicine, it was concluded that Avandia increased the risk of heart attacks by 43 percent. In July 2007, a committee of independent experts consulted by the FDA, however, decided that the risks did not warrant withdrawing the drug from the market.
Then another study, published in September 2007 in the Journal of the American Medical Association, was the first to examine the risks of heart problems and death stemming from the use of Avandia by Type 2 diabetes sufferers who had been taking the drug for at least a year.
The results of 4 clinical trials of more than 14,000 patients showed that Avandia taken over a prolonged period increased the risk of cardiovascular problems by some 42 percent.
FDA has expedited their review on the cardiovascular risks of this drug so that they could inform patients and doctors of their findings at the earliest possible time. Meanwhile, patients with Type 2 diabetes with underlying heart disease or at risk of heart attack are warned by FDA to talk to their doctors before taking the drug.
Some 7 million people around the world has taken the drug and half of them are in the United States. This also generates some 3.3 billion dollars of annual global sales for Glaxo.
Why warning has been issued suddenly for such a popular drug?
Based on an analysis of some 42 short-term clinical studies, published In May 2007 in the New England Journal of Medicine, it was concluded that Avandia increased the risk of heart attacks by 43 percent. In July 2007, a committee of independent experts consulted by the FDA, however, decided that the risks did not warrant withdrawing the drug from the market.
Then another study, published in September 2007 in the Journal of the American Medical Association, was the first to examine the risks of heart problems and death stemming from the use of Avandia by Type 2 diabetes sufferers who had been taking the drug for at least a year.
The results of 4 clinical trials of more than 14,000 patients showed that Avandia taken over a prolonged period increased the risk of cardiovascular problems by some 42 percent.
FDA has expedited their review on the cardiovascular risks of this drug so that they could inform patients and doctors of their findings at the earliest possible time. Meanwhile, patients with Type 2 diabetes with underlying heart disease or at risk of heart attack are warned by FDA to talk to their doctors before taking the drug.
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