FDA Panel Warns of Diabetes Drug's Safety

A Food and Drug Administration (FDA) advisory panel debated the safety of the diabetes drug Avandia today. In 2007, a study determined that Avandia raises the risk of heart attack in patients taking it. The drug’s safety and effectiveness have been hotly contested ever since.

Most of the panel members were not convinced by the drug’s manufacturer, GlaxoSmithKline, who argues that Avandia is safe. The New York Times’ Gardiner Harris live-blogged the panel’s he aring, and had this to say:

Twelve members voted to withdraw Avandia from the market, while 10 voted that it should continue to be sold but with serious revisions to its label as well as possible restrictions on its sale. Seven voted to simply add further warnings to the drug’s label. Three voted to allow further sales without change.

The vote is an enormous blow to Avandia and GlaxoSmithKline. The vast majority of panel members voted either to withdraw the drug or to allow continued sales only if strict controls are added. 

As Harris points out, a final decision has to be made by the FDA.

Harris also broke a story earlier this week that GlaxoSmithKline knew about the dangers of Avandia as early as 1999, not 2005 as it had earlier claimed. The company conducted a study comparing Avandia to another drug, Actos, and found that, while no better than Actos, it carried greater risk for patients. “The company did not post the results on its Web site or submit them to federal drug regulators, as is required in most cases by law,” Harris reports.

The whole situation reeks of a cover up. An internal email dated March 29, 2001, obtained by the Times, says, “Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK.”

At this point, it will be difficult for FDA not to take some serious action on Avandia. Whether the agency will go as far as pulling the drug from the market remains to be seen.

 

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