Federal Prosecutors Probe Diabetes Drug Avandia
British drug maker GlaxoSmithKline recently reported that its controversial diabetes drug Avandia is under investigation by federal and state law enforcement officials.
The announcement comes less than a month after the Food and Drug Administration issued severe restrictions on the use of Avandia because it increased the risk of heart attacks. Regulators in Europe pulled the drug off the market altogether.
The Department of Justice subpoenaed the drug maker to gain access to clinical data and marketing information amid accusations that the company failed to warn patients and doctors of the heart risks associated with the drug. Attorney Generals in several states are also investigating.
Avandia was once Glaxo’s third best-selling product, bringing in over $3 billion in sales in 2006. Sales plummeted the following year when a study revealed that Avandia increased the risk of heart attacks by 43%.
The federal probe follows years of investigation by congressional staffers into the company’s handling of the drug. Earlier this year a Senate Finance Committee report concluded that Glaxo knew about the risks of Avandia years before they were made public, and withheld important data from the FDA.