Consumer Group Urges FDA to Halt Study of Diabetes Drug Avandia

By Jim Greene

Published on May 18, 2010

A national consumer advocacy group is urging the U.S. Food and Drug Administration (FDA) to end a safety study of the diabetes drug Avandia® begun in 2007, claiming the study puts patients at risk unnecessarily. Public Citizen says other studies have already shown Avandia® to increase patients' risk for heart attack.

The FDA asked Avandia® (rosiglitazone maleate) maker GlaxoSmithKlein to compare the safety of its product to that of rival diabetes drug Actos® (pioglitazone HCl), made by Takeda Pharmaceutical Co. Both drugs are used to control blood sugar levels in type 2 diabetes patients.

Group Says Study Prospects Not Properly Advised

According to Public Citizen, continuing to recruit subjects for the study puts some at unnecessary risk because they are not adequately advised of other studies that show Avandia® to pose more risk than Actos®. Some scientists have said the lack of candor is unethical.

Despite the results of other studies cited by Public Citizen, the FDA plans to continue the Avandia®/Actos® study for five more years and recruit 16,000 subjects.

The FDA has ordered Glaxo to include warnings of the risk of heart problems in Avandia® packaging and literature, although the agency said the 65 reports of problems it has received are inconclusive. Warnings mention the possibility of damage to the muscles of the heart wall, resulting in reduced pumping ability that may result in heart attack or heart failure.

Lawsuits Accuse Glaxo Of Insufficient Warning

Hundreds of lawsuits have been filed against Glaxo, alleging heart problems caused by Avandia®. Plaintiffs accuse the company of not adequately warning patients and health professionals of heart risks of which the company was aware.

If you or someone you know has suffered a heart attack or heart failure or lost a loved one to heart problems after taking Avandia®, contact an experienced product liability attorney. You may be eligible for financial compensation to help you deal with medical bills, loss of income, loss of companionship, and pain and suffering.

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