Final Ruling on Diabetes Drug Avandia

Thu, 15 Jul 2010
A panel the US Food and Drug Administration has narrowly voted to permit the diabetes drug Avandia to stay on the market.

Twelve members voted to withdraw Avandia, however, ten voted for it to remain available with serious revisions to its label.

Seven members voted to place further warnings on the drug's label, with three voting to continue to allow sales without any changes.

Regulators from the US Food and Drug Administration (FDA) met during the last week to decide whether or not to recommend Avandia be pulled from the market, given concerns that it may increase the likelihood of heart problems .

Concerns have been raised over the drug, manufactured by GlaxoSmithKline, since a 2007 analysis which suggested that diabetics who were on it were more likely to die of a heart attack than those on other diabetes medications.

A study of 200,000 plus patients led by the FDA's David Graham and published in June, concluded that Avandia raises the risk of heart failure and stroke by approximately 25 per cent in contrast with patients on competing drug pioglitazone .

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