Courtesy www.npr.org
A panel of Food and Drug Administration experts voted to relax regulations on a controversial diabetes drug that the government agency had voted to remove form the market in 2010 over safety concerns. Thirteen members of the 26-member panel voted to soften the restrictions on Avandia. Once one of the pharmaceutical industry’s biggest moneymakers, it became a drug of last resort in recent years, used by just a few thousand people.
The drug’s maker GlaxoSmithKline had defended Avandia’s reputation despite accusations of mishandled trials and downplayed safety risks. At one point, Avandia brought in more than $3 billion in sales. However that changed when Dr. Steven Nissen, a Cleveland Clinic cardiologist, warned that some studies showed the drug increased the risk of heart attack by over 40 percent.
Of the twelve FDA panelists who voted to remove Avandia from the market in 2010, only three were present for last week’s vote. FDA representatives said they had invited everyone who had attended the 2010 meeting.
In the most recent vote, panel experts essentially endorsed a recent review of a clinical trial by GSK that was first published in 2009. The review confirmed the trial’s original results, after an FDA scientist asserted that some of the trail results were framed to favor the approval of Avandia.
In a statement, GSK said it would work with the agency on the potential changes. Under GSK’s current restrictions, the drug can be used after patients have failed to benefit from all other treatments. It is only available at certain pharmacies and both physicians and patients must acknowledge that they realize the risks involved with taking the drug.
Some still have safety concerns
Nissen, who first raised concerns about Avandia, told the New York Times that he was happy with the decision.
“It lets the FDA save face, but it doesn’t really expose an infinite number of patients to this drug,” he said.
Tufts Medical Center execute Dr. Marvin Konstam, who voted to loosen the restrictions, said the review did not completely settle safety issues, “but in my mind they move the needle in the direction to shift the burden in decision-making,” to physicians. In 2010, he was one of those voting to withdraw the drug from the market.
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