U.S. health authorities were aware of heart risks linked to GlaxoSmithKline Plc’s widely prescribed diabetes drug Avandia and another competitor nearly five years ago, consumer advocacy group Public Citizen said on Tuesday.
In 2002, U.S. Food and Drug Administration staff scientists called for reports of congestive heart failure to be included on the label of Avandia as well as Actos, made by Takeda Pharmaceutical Co. Ltd., the group said, citing an internal FDA document.
The group released the memo one day after researchers reported Avandia, or rosiglitazone, raises the risk of cardiovascular-related death by 64 percent and the risk of heart attack by 43 percent.
Glaxo strongly objected to the results and defended use of the drug, which treats type 2 diabetes.
At the same time, the FDA said an agency analysis showed a higher risk but it was not yet completed, adding other studies contradicted the latest findings. It called on patients to talk to their doctors but stopped short of taking other action.
Dr. Sidney Wolfe, head of Public Citizen’s Health Research Group which has been critical of Avandia for years, said the 2002 memo showed the agency failed to take the concerns of its staff scientists seriously.
“As a result, millions of people — to the detriment of their health — are prescribed drugs whose risks are dangerously understated, instead of being prescribed safer, equally or more effective alternative drugs,” he said in a statement.
Call for black-box warning
In a letter to FDA Commissioner Andrew von Eschenbach, Wolfe urged the agency to impose the strongest warning possible — a black box — on both Avandia and Actos, or ban them outright.
“There continues to be no mention of the large and increasing number of post-marketing reports of heart failure, which was the explicit recommendation in the 2002 internal FDA memo,” Wolfe wrote.
An FDA spokeswoman could not be immediately reached for comment.
Actos, also known as pioglitazone, and Avandia, are part of a class of drugs known as thiazolidinediones (TZDs) that target the PPAR-gamma gene to help the body use insulin more effectively.
FDA staff reviewers, in a memo dated July 16, 2002, said they analyzed reports of heart failure that led to patient hospitalizations in an agency post-marketing database.
“Data from this case series provides evidence that TZDs may be associated with CHF (congestive heart failure) to an extent not clearly defined in the product labels,” the staffers wrote.
They added that the exact link between the drugs and the heart problems could not be established, and that increased patient monitoring may have also boosted the number of diagnoses.
Still, the reviewers concluded that reports of heart problems in patients taking Avandia and Actos existed and should be mentioned on the products’ labels.
Separately, three major medical organizations have issued a joint statement saying diabetes patients should stay on their medications until they speak to their doctors.
