The Food and Drug Administration said Monday that it was loosening restrictions on the controversial diabetes drug Avandia `` to reflect new information regarding the cardiovascular risk . '' An advisory panel voted in June to recommend loosening restrictions put in place in 2010 , when the FDA limited Avandia use to patients with type 2 diabetes who could not control their illness with other medications . That decision was based on studies showing an increased risk of serious heart problems in patients taking Avandia , most notably a 2007 analysis by Dr. Steven Nissen , a cardiologist at the Cleveland Clinic , showing a 43 % increase in heart attacks . The finding led the FDA to order GlaxoSmithKline , the drug 's maker , to conduct a thorough study of its safety . The full results of that study , known as RECORD , were made public in 2009 . Results from RECORD `` showed no elevated risk of heart attack or death in patients being treated with Avandia when compared to standard-of-care diabetes drugs , '' the FDA said in a statement Monday . `` These data do not confirm the signal of increased risk of heart attacks that was found in a meta-analysis of clinical trials first reported in 2007 . '' `` Our actions today reflect the most current scientific knowledge about the risks and benefits of this drug , '' said Dr. Janet Woodcock , director of the FDA 's Center for Drug Evaluation and Research , in the statement . `` Given these new results , our level of concern is considerably reduced ; thus , we are requiring the removal of certain prescribing restrictions . '' Video : FDA restricts diabetes drug Avandia . Although GlaxoSmithKline said the safety data were reassuring , the study was heavily criticized by Dr. Thomas Marciniak , an FDA scientist who reviewed the data and said the company ignored several cases of patients who suffered severe adverse effects . Because there were multiple conflicting signals of cardiovascular risk associated with the drug , Woodcock recommended that Glaxo commission an outside independent group to review RECORD 's results . GSK chose the Duke Clinical Research Institute to re-examine the data and held a June hearing on the results . The institute 's associate director , Dr. Kenneth Mahaffey , said that it performed a comprehensive review and that its data were consistent with the RECORD results . In June , some members of the FDA panel questioned the severity of the current restrictions and the scope of cardiovascular events caused by taking the drug . `` I am considerably reassured ... that the magnitude of risk is not great , '' said Dr. Dale Hammerschmidt , one of the panelists who voted to modify the warning . He added that he thought the current warning was more severe than necessary but should not be removed entirely . As of June , only 3,000 patients in the United States were registered to take Avandia , according to GlaxoSmithKline spokeswoman Mary Ann Rhyne . That 's compared with the 120,000 patients taking the drug in 2010 before the restrictions were put in place .
Restrictions on Avandia were put in place in 2009 . Studies show an increased risk of serious heart problems . Additional research shows no additional cardiovascular risks with Avandia .