Avandia could remain available following FDA advisory committee vote

Diabetes drug, shown to carry cardiovascular risk, remains restricted under REMS program

PHILADELPHIA — A joint Food and Drug Administration expert panel voted to recommend keeping a controversial GlaxoSmithKline diabetes drug available for certain patients, GSK said.

The drug maker said that in a vote on the drug Avandia (rosiglitazone), a majority of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee members — 13 and seven, respectively — voted to modify or remove the drug's safety protocol, known as a risk evaluation and mitigation strategy, or REMS. REMS are used for drugs that are approved by the FDA but may pose a safety risk to patients. Five members voted to keep the REMS, while one voted to remove Avandia from the market.

The vote was based on a reevaluation of GSK's 2009 RECORD study, and the FDA will take it into consideration when it decides whether or not to maintain the current safety protocol for Avandia, which will continue to be available through the REMS program. The second analysis of the RECORD study indicated Avandia may not carry higher risk of heart attacks than other diabetes medications.

"We appreciate the committee's thorough examination of the RECORD results and will continue to work with the FDA as it considers the recommendations of the committee," GSK chief medical officer James Shannon said. "We continue to believe that Avandia is a safe and effective treatment option for Type 2 diabetes when used for the appropriate patient and in accordance with labeling."

The controversy surrounding Avandia goes back to 2010, when the FDA moved to significantly restrict access to the drug — once a top-selling Type 2 diabetes drug on the market — in response to a 2007 study suggesting its use could increase the risk of heart attacks and strokes. The drug was made available only to patients if they could not control their blood-sugar levels with Takeda's Actos (pioglitazone), a drug that belongs to the same class as Avandia. Meanwhile, regulators in the European Union banned the drug altogether.

In January 2011, GSK took a legal charge of $3.4 billion related to an investigation by the U.S. Attorney's Office for the District of Colorado alleging that it continued selling and promoting the drug in spite of reports of its cardiovascular risks, and the drug's labeling was revised a month later. In November 2011, Avandia was pulled from retail pharmacy shelves and made available only by mail order from specially certified pharmacies.


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