Results of Avandia Heart Attack Study to be Re-Evaluated by FDA

Federal drug experts are planning to re-evaluate the safety of the diabetes drug Avandia, which has been severely restricted in the United States amid concerns that users may face an increased risk of heart attacks and death. 

The FDA will hold a hearing of medical expert testimony on June 5 and 6, to re-assess the side effects of Avandia and the findings of a clinical trials conducted by the manufacturer, GlaxoSmithKline.

The safety reassessment comes three years after the FDA enacted heavy restrictions that pushed Avandia from a leading diabetes drug to a medication that is used by no more than an estimated 3,300 users today.

The joint meeting of the FDA’s Endocrinologic and Metaboloc Drugs Advisory Committee and its Drug Safety and Risk Management Advisory Committee was published today in the federal register. The meeting will be open to the public and held at the FDA’s White Oak Campus, Building 31, in Silver Spring, Maryland.

Avandia (rosiglitazone) was a popular type 2 diabetes drug that was used by millions of people before it was linked to an increased risk of heart attacks and heart problems in 2007. Avandia was almost recalled from the market, but has remained available under severe restrictions imposed by the FDA in 2010.

Some reports have suggested that as many as 100,000 heart attacks may have been caused by Avandia, and the drug’s manufacturer has reportedly paid more than $1 billion to settle Avandia heart attack lawsuits brought by former users of the medication who allege inadequate warnings were provided to consumers and the medical community.

The original study which raised the concern of Avandia heart attacks was led by Dr. Steven Nissen of the Cleveland Clinic in 2007. However, that was followed by another study, the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial by researchers at Duke University.

RECORD determined that there was no increased risk of heart attack linked with Avandia, but in 2010 FDA experts called RECORD flawed and determined that it likely undercounted the number of Avandia heart attacks. Later that year, it was restricted severely in use and GlaxoSmithKline ceased to market the once-blockbuster diabetes treatment. Sales went from more than $3 billion before the restrictions to just $1.9 million last year.

The re-evaluation comes as a result of Glaxo taking a second look at the study, which they were ordered to do by the FDA. Company officials say the study’s findings still indicate that there is no increased risk of Avandia heart attacks when compared to other diabetes drugs.