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A significant majority-20 of 26 members attending a combined meeting of FDA advisory committees-has voted to modify or remove the current restrictive label and distribution regulations affecting the type 2 drug Avandia.
Avandia (rosiglitazone), manufactured by GlaxoSmithKline, was introduced in 1999 The drug, a thiazolidinedione (TZD), works by increasing the sensitivity of cells to insulin. A beneficial side effect of the drug was that it was less likely than other type 2 drugs to induce hypoglycemia.
A similar TZD is Actos (pioglitazone) from Takeda Pharmaceuticals.
At its peak, Avandia reached a high of 117,000 U.S. users and $3 billion in sales before concerns that it might increase the risk of heart attack and stroke caused to FDA in 2010 to impose severe restrictions on its distribution and use. Today an estimated 3,400 patients who cannot achieve glycemic control with other type 2 medications take the drug.
Avandia is banned in Europe.
The vote by the FDA's Endocrinologic and Metabolic Drugs, and Drug Safety and Risk Management Advisory committees, was heavily in favor of at least modifying current restrictions, if not removing them entirely. (Thirteen of the 20 panelists voted to modify; seven voted for total removal. Of the dissenting panelists, five voted to keep current restrictions in place, while one voted to remove Avandia entirely from the market.)
The committees' recommendation comes after an independent reviewer revisited GSK's original study of Avandia and the risks associated with it. They concluded that the re-examined data showed that Avandia does not carry any higher a risk of cardiovascular problems than other drugs in its class.
While the FDA is not obligated to follow an advisory committee's recommendations, it usually does since a committee has detailed knowledge of a drug's history and the studies that have been devoted to it.
The most likely effect if the FDA loosens restrictions on Avandia is that physicians will find it easier to prescribe the drug to a wider range of diabetes patients.
0 comments - Jun 9, 2013