The Food and Drug Administration (FDA) may remove the diabetes drug Avandia from the market after two studies indicate an increased risk of heart attack, stroke, and death. A large 35,000 patient study and another government analysis both utilized different methods, however arrived at the same conclusion. The studies state that Avandia patients were 25% more likely to have a heart attack, 27% more likely to have a stroke, and 14% more likely to die with an 18% increased risk for all three. This follows a Senate investigation earlier this year finding GSK did not do enough to alert the FDA and patients about potential side effects.
GlaxoSmithKline (GSK) which produces the drug released a statement arguing that other studies have found the drug safe. The company released six studies after worries were first raised citing no increase in heart or stroke risk factors and a review of 52 other studies showing little to no increase in heart attack or stroke risk factors.
Will the FDA maintain the status quo, add additional warnings, or remove the drug from the market? Time will tell, but let us know what you think. Check out the links below for more info.
Sources:
Washington Post
Bloomberg Business Week
Los Angeles Times
Associated Press
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