Group questions FDA on other Avandia risk
WASHINGTON (Reuters) - U.S. health authorities were aware of a type of heart risk 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 other heart-related problems -- cardiovascular-related death by 64 percent and heart attack by 43 percent.
Glaxo strongly objected to Monday's results and defended its drug, which treats type 2 diabetes.
The FDA said Monday an agency analysis showed a higher risk but it was not yet completed, adding other studies contradicted the latest findings. It urged patients to talk to their doctors.
Dr. Sidney Wolfe, head of Public Citizen's Health Research Group which has criticized Avandia use for years, said on Tuesday the 2002 memo showed the agency failed to take the concerns of its staff scientists seriously.
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.
Separately, Sen. Charles Grassley of Iowa, ranking Republican on the Senate Finance Committee, said that at least one of the FDA's diabetes experts was removed from involvement with Avandia.
FDA spokeswoman Julie Zawisza said disagreement among agency staffers exists, especially when data is complex, but that no staff member was removed from the Avandia review.
"The agency's position on Avandia is that this is a very complicated scientific issue; the data are evolving and we need to continue to analyze them as quickly as possible," she said in a statement.
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 the 2002 memo, 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," they wrote.
They added that the exact link between the drugs and congestive heart failure was unclear, and that increased patient monitoring may have also played a role.
The reviewers concluded that reported congestive heart failure in patients taking Avandia and Actos should be mentioned on the products' labels. Additional studies should also be considered, they wrote.
Other experts, however, have downplayed the congestive heart failure risks.
"It is a reversible problem. You stop the drug, take a diuretic and you get better. Myocardial infarction (heart attack) is irrevocable and certainly death is irrevocable," Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic who helped conduct the latest research, said on Monday.
Still, Wolfe said the congestive heart failure cases in question led to hospitalizations and were serious. "Heart failure it its extreme form can be fatal," he said in an interview.
(Additional reporting by Maggie Fox)
