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FDA advisors support GSK's Avandia

Two US FDA advisory committees have voted to recommend GlaxoSmithKline's Avandia stays on the market in spite of safety concerns

Members of two advisory committees to the US Food and Drug Administration (FDA) have voted to recommend that the agency allow GlaxoSmithKline's (GSK) blockbuster diabetes drug Avandia (rosiglitazone) to stay on the market in spite of safety concerns.

The 20-to-12 vote was taken at a joint meeting of the Endocrinolic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee convened by the FDA in light of an ongoing debate over whether Avandia presents an unacceptably high increase in the risk of heart attack and stroke. The final decision about the drug remains in the hands of the FDA itself, but the agency generally takes the opinions of its outside advisors seriously.

Most of the advisors who favoured allowing continued marketing of the drug also pushed for new warnings and restrictions. In addition, the advisors voted 21-to-four that Avandia is more likely to cause heart attack than Takeda's competing drug Actos (pioglitazone). The conclusion that Avandia is more dangerous than Actos, which is being reported in consumer news outlets, is likely to hurt sales of the GSK drug, which have already been slashed by the ongoing safety debate.

Avandia has become a key symbol for many activists and politicians who believe the FDA is too lax in its post-marketing oversight of drugs. Groups like the consumer watchdog organisation Public Citizen have prevailed on the FDA to pull the drug, and lawmakers including the Connecticut Congresswoman, Rosa DeLauro have taken the agency to task over its handling of the drug.

"The result of the advisory committee vote is gravely disappointing and raises serious questions as to whether the science was presented in an unbiased manner to the committee members," DeLauro. "I intend to ask the FDA some serious questions as to whether the advisory committee proceedings were a result of the agency's ongoing internal debate and in some way helped to ensure that Avandia would not be pulled from the market."

"If the FDA is to be a force for change and for returning to the gold standard for safety for which it was once known, then its upcoming decision on whether to pull Avandia from the market will be the defining moment for the agency under the Obama administration," the Congresswoman added.

15th July 2010

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