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FDA Overturns Safety Limits on Diabetes Drug Avandia

The FDA recently overturned safety limits that restricted the sale of the diabetes drug Avandia (rosiglitazone).  The drug, manufacturered by GlaxoSmithKline had been much debated over the past several years due research done in 2007, which suggested that use of the drug was linked to a higher risk of heart attack.  The FDA limited the sale of the drug in response to the research findings in 2010 that suggested it use might be dangerous.  Now the drug is being unrestricted meaning that those suffering from diabetes will not have to enroll in a special program to obtain the drug.  This recent action by the FDA is not without controversy however, since no new information concerning the drug has been made available since the original decision was made.  Additionally, the doctor at the head of the 2007 study, which resulted in the FDA's safety restrictions is questioning the motives of the FDA. 

The FDA said that its decision is in line with advice it has received from expert advisory committees.  Prior to lifting the safety restrictions the FDA hired Duke University to revisit the 2007 study.  The results from Duke's research matched that of the drug maker's--that use of the drug does not appear to increase the risk of heart attack.

Interestingly in 2012, Glaxo pled guilty for failing to report safety complications of Avanda to government officials.   


AP, "FDA Overturns safety limits on diabetes drug," by Matthew Perrone, November 25, 2013., "FDA removes restrictions on Avandia," by Larry Husten, November 25, 2013.

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