Weitz & Luxenberg Responds to Study Casting Further Doubt on Avandia

10/1/2007- A further pall has been cast over Avandia, a drug for Type 2 diabetes. A new study has found that long-term use of the pharmaceutical increases heart attack risk by more than 40 percent and doubles the chance of heart failure. These findings are nearly identical to that of another recent scientific analysis out this spring.

"Millions of people with diabetes trusted Avandia to help control the disease," said Perry Weitz, founding partner of Weitz & Luxenberg, P.C. "These individuals should have been informed much earlier on about the serious cardiovascular risks."

Drug giant GlaxoSmithKline Plc, maker of Avandia, had been warned by U.S. regulators as early as 2001 against attempting to play down the risk of cardiac disease associated with Avandia in its marketing materials. Additionally, the Food and Drug Administration only announced in June that the toughest so-called "black box warning" label would be placed on Avandia--this is more than a year after FDA safety reviewers reportedly recommended taking that urgent step.

Concern over the safety of Avandia only reached the public in May 2007, when the New England Journal of Medicine published a combined analysis of more than 40 studies. That report, widely covered by mainstream media, found that Avandia significantly raised the risks of heart attacks.

The new analysis, by researchers from Wake Forest University Baptist Medical Center and published in the September 12 issue of the Journal of the American Medical Association, is one of the first to evaluate how long-term use of Avandia affects risk of heart attacks, heart failure and mortality. The four studies involved followed more than 14,000 patients for at least a year. Researchers found that long-term use of Avandia (known generically as rosiglitazone) increased the risk of heart attack by 42 percent and doubled the risk of heart failure.

Lead author on the study, Sonal Singh M.D., estimated that 3.5 million patients in the U.S. take Avandia for diabetes. In a Wake Forest press release, Singh said the study's findings suggest that Avandia "may cause more than 4,000 excess heart attacks and 9,000 excess cases of heart failure a year."