Avandia Heart Attack Risk Twice as High as Other Diabetes Drugs: Study

The results of a new study indicate that side effects of Avandia may double the risk of heart attacks when compared to other diabetes drugs.

The new study, published in the American Diabetes Association medical journal, Diabetes Care, compared Avandia heart risks to those of Actos and other anti-diabetic drugs. Researchers from Harvard Medical School and Massachusetts General Hospital looked at hospital databases and compared the rate of myocardial infarctions in diabetic patients with the medications they were prescribed.

The study looked at more than 26,000 patients, and found that Avandia users suffered twice as many heart attacks as diabetes patients who were given Actos (pioglitazone) and metformin. Avandia users were 1.2 times as likely to have a heart attack as patients given sulfonylurea.

Avandia (rosiglitazone) is manufactured by GlaxoSmithKline PLC, and is a thiazolidinedione agent, a class of drugs approved by FDA in 1998 to treat type 2 diabetes by helping control blood sugar levels.

Concerns about the Avandia heart attack risk first gained widespread attention in May 2007, when a meta-analysis of 42 different clinical trials was published in the New England Journal of Medicine, suggesting that users of Avandia had a 43% increased risk of a heart attack. The FDA has since added a black box heart attack warning to Avandia, and some experts have estimated that the diabetes drug could be responsible for as many as 100,000 heart attacks since it was first introduced.

GlaxoSmithKline PLC currently faces thousands of Avandia lawsuits filed by former users of the drug who allege that the drug company failed to adequately research their medication or warn users about the serious heart side effects. Federal Avandia litigation has been consolidated into an MDL, or Multidistrict Litigation, for pretrial litigation in the U.S. District Court for the Eastern District of Pennsylvania.

In 2008, Public Citizen filed a petition with the FDA calling on the agency to issue an Avandia recall, indicating that the number of serious and potentially life-threatening side effects outweigh any potential benefits provided by the diabetes drug. The FDA has not yet taken any action on the petition.