FDA To Rule On Diabetes Drug Avandia
By: Ray Doughty
Updated: July 12, 2010
All eyes will be on the FDA next week as its advisors weigh the pros and cons of the popular diabetes drug Avandia.
Data on the drug up until this point have been conflicting but a new, comprehensive FDA report released today may give experts the information they need to make major changes in the diabetes drug market.
The blockbuster diabetes drug Avandia is under the microscope again with a highly anticipated FDA advisory committee review of the drug scheduled for next week.
A 2007 study published in the New England Journal of Medicine linked Avandia with a greatly increased risk for heart attack. It triggered a black box warning for the drug, but no market withdrawal.
A separate study funded by Avandia manufacturer, Glaxo-Smith-Kline, found the opposite, no increased risk for heart attack in a study of 4,500 patients.
Since then, the FDA has taken a closer look at all the research and released a massive, 700 page report that suggests Glaxo scientists were wrong.
Steven Nissen, M.D., a cardiologist at the Cleveland Clinic, says "the main study makers of Avandia were going to use to defend the drug actually turns out to show the risks of the drug in the FDA analysis."
Now it's up to fda advisors to sort through the back-and-forth research and vote on whether to take the drug off the market for good.
A spokesperson for Glaxo-Smith-Kline stands by the drug, saying its studies that show avandia does not increase the overall risk for heart attack, stroke and death.
