(Photo : Reuters)
The U.S. Food and Drug Administration in June will reconsider the safety diabetes drug Avandia.
Once one of GlaxoSmithKline 's biggest drugs, Avandia saw annual sales top $3 billion, reports the Wall Street Journal.
But sales of the drug plummeted after a study in 2007 linked it to heart attacks and then the FDA three years ago opted to severely limit the use of Avandia.
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Recent data from market analyst IMS Health show that the drug had U.S. sales last year of just over $1.9 million.
Meanwhile, the medication's maker, British-based GlaxoSmithKline, has announced it in fact has not sought permission to make the nearly-discontinued drug widely available in the United States again.
"We haven't asked for any changes in the drug label or in distribution for Avandia," said Glaxo spokeswoman Mary Anne Rhyne, who clarified the company had not requested the planned June 5-6 meeting of the FDA's Endocrinologic and Metabolic advisory panel, which will be held jointly with the FDA's Drug Safety and Risk Management Advisory committee.
The FDA's 2010 decision directed the drug should only be available to patients unable to control their diabetes with any other drug.
Glaxo estimates about 3,300 patients in the U.S. still take the once-highly popular pill.
Rhyne said the FDA's expected review of Avandia will likely be a follow-up to a request for additional safety information it asked from Glaxo in 2010.
The panel had asked the company to commission a re-examination of a large study of Avandia to better assess the drug's safety. It also asked the company to craft a Risk Evaluation and Mitigation Strategy plan --- basically a better way to control the drug's availability and use.
Rhyne added a group of medical experts from Duke University re-examined Avandia data recently submitted its findings to the FDA.
She said the Duke University researchers found there was no significant difference in cardiovascular safety between Avandia and two other types of widely used oral drugs, metformin and sulfonylureas.