Avandia Still on Market with Label Revisions, Possible Restrictions

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Conflicting data prevented an advisory committee to the FDA from pulling Avandia completely from the market, but changes are coming and none of it looks all that good for GlaxoSmithKline.

An advisory committee to the FDA has voted to keep GlaxoSmithKline’s Avandia (rosaglitazone) on the market, but with label revisions and “possible restrictions.” 12 of 33 panelists voted in favor of outright withdrawal, while 10 voted for continued marketing with restrictions. This outcome was not entirely surprising considering the wave of negative publicity and damning clinical data surrounding the type 2 diabetes medication.

Though panelists made no mention of its influence on their decision, GSK’s credibility took a hit by the embarrassing revelation of 11-year-old internal documents (when GSK was SmithKline Beecham) which clearly show that the company was well aware of the risks Avandia posed to patients’ heart health, and that the company was actively involved in a cover up of the in-house study that produced the data.

Even without this untimely news, Avandia has been dogged by safety concerns since the publication of a 2007 study in the New England Journal of Medicine linking it to increased cardiovascular risk. There have also been questions raised about GSK’s handling of the RECORD trial, an in-house study which some allege “excluded deaths among patients taking Avandia from the study that would have shown that the drug increased the risk for heart attacks.”

Still, Avandia had its defenders, even within the FDA, and no less an authority than Endocrine Society President Robert Vigersky, Director of the Diabetes Institute at the Walter Reed Health Care System and Professor of Medicine at the Uniformed Services University of the Health Sciences argued for keeping the drug on the market. Their testimony, however, was not enough to sway a majority of panelists.

Coincidentally (or not), GSK agreed earlier this week to settle most of its outstanding Avandia-related litigation for $460 million, though it will write down $2.4 billion altogether in total legal costs. Forbes senior editor Robert Langreth called Avandia “as good as dead as a commercial product,” but UBS analyst Gbola Amusa praised the move as “good for the market,” as they were expecting a worst-case-scenario liability of more than $6 billion.

Response from the endocrine wing of the healthcare sector was very much go with the flow. The American Association of Clinical Endocrinologists, the American Diabetes Association, and The Endocrine Society released a joint statement indicating that they “await further information from the Food and Drug Administration following the completion of the Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee,” and that “until further clarification is provided by the FDA, the decision whether or not to use any medication must remain that of the treating provider in direct discussion with the individual patient.”

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