FDA panel loosens restrictions on Avandia

June 9, 2013 12:01:13 AM PDT
New research may lead to fewer restrictions on a controversial diabetes drug.

Avandia can only be used by people with type 2 diabetes. Restrictions were put in place three years ago after some studies linked the drug to an increased risk of stroke and heart problems.

An FDA panel now said an independent review of the drug actually confirmed the manufacturer's claims that the magnitude of risk is really not significant.

Looser restrictions could mean a lot more people will start taking Avandia. About 3,000 patients are registered as taking it. Before the FDA initiated those restrictions, that number was 120,000. The FDA commissioner would still need to approve whether the restrictions are loosened.


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