Avandia, the brand name for rosiglitazone, is manufactured by GlaxoSmithKline and is prescribed to treat type 2 diabetes. However, controversy has swirled around the medication in recent years due to claims that it causes heart attacks.
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GlaxoSmithKline in July 2012 said that it will plead guilty and pay a $3 billion fine to address federal civil and criminal investigations involving three of its drugs – Paxil, Wellbutrin and Avandia – according to The New York Times. The company pleaded guilty to one count of failing to report safety information regarding Avandia to the U.S. Food and Drug Administration.
U.S. officials said the company did not tell the FDA about safety information it discovered from two studies regarding the effects of Avandia on the heart.
"Today's multibillion-dollar settlement is unprecedented both in size and scope," said James M. Cole, deputy attorney general. "It underscores the administration's firm commitment to protecting the American people and holding accountable those who commit health care fraud."
Andrew Witty, the company's chief executive, offered a statement indicating that this was the way things were conducted previously by the British pharmaceutical giant. "Whilst these originate in a different era for the company, they cannot and will not be ignored," Witty said in a statement the Times published. "On behalf of GSK, I want to express our regret and reiterate that we have learnt from the mistakes that were made."
Previously, GlaxoSmithKline paid $700 million to settle patient lawsuits in the U.S. that claimed Avandia caused heart attacks and strokes.
The FDA in 2007 directed the drug manufacturer to put a black box warning on the medication's label stating there is a potentially increased risk for heart attack. This action came after the New England Journal of Medicine in 2007 published results of a study that linked Avandia to heart attacks.
FDA officials did consider removing Avandia from the market, but the FDA oversight committee narrowly voted to permit the manufacturer to continue to sell the drug.
U.S. Senator Max Baucus, D-Montana, the head of the Senate Finance Committee, and Sen. Charles Grassley, R-Iowa, the committee's ranking Republican, have been exploring questions regarding the drug's safety, the manufacturer's conduct and the FDA's oversight since 2007.
In 2010, these two senators alleged that GlaxoSmithKline did not inform the FDA quickly about research that indicated Avandia increased the risk of serious heart problems.
Avandia is made by GlaxoSmithKline for treatment of type 2 diabetes. Some individuals allege the drug is linked to heart attacks. The drug manufacturer in July 2012 pleaded guilty to one count of failing to report safety information about Avandia to the FDA. GlaxoSmithKline agreed to pay a $3 billion fine to handle federal civil and criminal investigations for Paxil, Wellbutrin and Avandia. The company has paid $700 million to settle lawsuits in the U.S. in which plaintiffs claimed Avandia caused heart attacks and strokes.