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FDA Panel Votes to Loosen Restrictions on Avandia
Expert panel reviews data on heart damage attributed to controversial drug

FRIDAY, June 7 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel met Wednesday and Thursday to discuss the fate of the diabetes drug Avandia (rosiglitazone), concluding in a vote in favor of easing restrictions on access to the drug. The exact nature of these restriction changes are yet to be determined.

Two years ago, Avandia was essentially banned from the marketplace after researchers found an increase in heart problems in patients taking the drug. Today, it is considered a last resort for patients with diabetes who are so sick that the benefit of the drug outweighs the possible increased risk of a heart attack.

The FDA panel looked at evidence from a review by Duke University researchers of Avandia's original clinical trial, called the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes (RECORD) study. The Duke researchers concluded that Avandia does not raise the overall risk of heart disease. Among the 26 members of the FDA panel, 13 voted to amend the safety restrictions, seven voted to remove all of the restrictions, five voted to keep the restrictions as they are, and one member voted to completely remove Avandia from the shelves.

"The FDA strongly believes that regulatory decisions should be based on strong scientific evidence. If such evidence becomes available to revisit previous regulatory decisions, it is important for the FDA to consider this evidence in a transparent process," FDA spokesperson Morgan Liscinsky said. "The FDA is critically evaluating the RECORD re-adjudication. Once the advisory committee meeting has been held and review is complete, the FDA will determine if the results of the re-adjudication in the context of all the pertinent available data affect the agency's assessment of the risk-benefit information for rosiglitazone [Avandia]."

Avandia is manufactured by the North Carolina-based GlaxoSmithKline, which funded the Duke University review.

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