An analysis of GlaxoSmithKline’s diabetes drug Avandia published in the New England Journal of Medicine says elevated heart risks are associated with the medication, and members of Congress from both parties are voicing their concerns.

Representative Henry Waxman, D-California, chairman of the House Committee on Oversight and Government Reform, announced that a hearing has been scheduled for June 6, 2007 to discuss the role of the U.S. Food and Drug Administration (FDA).

Iowa Republican Charles Grassley has criticized the FDA for not responding more quickly or efficiently to concerns about the safety of Avandia.

“Do we have another Vioxx on our hands with Avandia? I am not sure, but I intend to find out,” Grassley said. “Tens of millions of prescriptions have been written for Avandia, and Medicare and Medicaid have paid hundreds of millions of dollars for this drug.”

Vioxx was a drug to relieve signs and symptoms of osteoarthritis, acute arthritis pain and painful menstruation. It was recalled on September 29, 2004 after a trial found that patients taking Vioxx were at a greater risk of sudden cardiac deaths. The drug was recalled from the market.

The FDA has received criticism for not studying the safety of Avandia. Agency officials said their evaluations of the drug provided conflicting data and did not prove the drug was dangerous.

GlaxoSmithKline has disputed the results of the new analysis. The company cited a similar review that found a 30 percent increased risk of heart problems associated with Avandia, but said the risk was not confirmed after additional studies.

The FDA said an advisory panel would be convened to discuss the safety of Avandia, but it did not plan to make any immediate changes to the current side effects warnings on the packaging of the drug.

Grassley also said that nearly five years ago the FDA’s safety office recommended that Avandia have the strongest possible warning, but the recommendation was overruled by other FDA offices.

“The FDA didn’t take that advice,” Grassley said. “Instead, the warning about congestive heart failure risks with this drug is currently buried.”

Grassley is the ranking Republican for the Senate Finance Committee, one of three congressional panels investigating the FDA’s management of Avandia. The FDA is also conducting a review.

Source: Marilynn Marchione, “Diabetes drug may raise risk of heart attack,” PressofAtlanticCity.com, May 22, 2007; Ricardo Alonso-Zaldivar, “Diabetes drug Avandia caused concern 5 years ago,” Star Tribune, May 23, 2007; Ricardo Alonso-Zaldivar, “Concerns about diabetes drug Avandia aren’t new,” LA Times, May 23, 2007.