Posted: 07-01-10 Categories:
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Cardiac researcher predicts new heart risks warning, but no Avandia recall by FDA

Three new studies about Avandia side effects and heart risks were released this week.  Two of the studies, published in the Journal of the American Medical Association and the Archives of Internal Medicine, link the diabetes drug to an increased risk of heart attack, stroke or heart failure.

The third study,  presented on June 29 during the annual meeting of the American Diabetes Association (ADA), suggests that taking Avandia may be associated with a lower risk of heart attack, stroke or death than not taking Avandia or Actos, its rival TZD. 

“Our observational study does not suggest a significant cardiovascular hazard and may suggest a beneficial effect on ischemic cardiovascular events associated with treatment with rosiglitazone among patients with type 2 diabetes and established coronary artery disease,” said Dr. Richard Bach, a researcher at Washington University School of Medicine in St. Louis.   After 4.5 years, “the occurrence of death, heart attack and stroke was 28 percent less frequent” for patients taking Avandia as compared with patients not taking a TZD (Avandia or Actos).

Avandia critics question Dr. Bach’s findings.  GlaxoSmithKline provided funding for the study, a conflict of interest some believe taint the results.  The research was not randomized.  The participants and their doctors chose whether to take Avandia.  Some contend that the research was too narrowly focused and involved too few patients to have any broad significance.

A FDA drug safety advisory committee meets in July to review all Avandia safety and efficacy data.  The controversial Type 2 diabetes drug is known to increase the risk of heart failure and bone fractures.   Current data suggests Avandia also raises the risk of heart attacks, strokes and death.  As the FDA meeting approaches and Avandia lawsuit settlements are reported, demands for an Avandia recall are intensifying.  Many believe a FDA decision to recall Avandia will be announced at the July meeting.

Others disagree.  Dr. Kirk Garratt, clinical director of interventional cardiovascular research at Lenox Hill Hospital in New York City, predicts that,  “The FDA will look at this and when they put this together [with other research] they will come up with a warning — be thoughtful about how to prescribe this — but they will not take it off the market.”

Why the apparent inconsistencies in the results of the studies?  Garrat speculates, “age is playing a role in a manner we don’t even understand.” “Because genes change over time, perhaps this type of drug is going to have different outcomes in different age groups,” said Garratt.

“What we can conclude now looking at the question from multiple different angles is that we have failed to come up with a consistent message, Garratt added.” “My guess is that the marketplace will see some additional fall-off in the use of Avandia, but we know that some has already taken place. Those of us who are prescribing the medication from a cardiovascular practice perspective are already cautious. As this gets more press, that degree of caution will filter down to the internist, the family medicine physician and the diabetes expert.”

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