In May 2007, the New England Journal of Medicine published a report suggesting that the widely-prescribed diabetes drug Avandia may significantly increase the risk of heart attack and heart-related death--especially in those who have a prior history of heart disease or who are considered at risk for a heart attack. Immediately following the report, the U.S. Food and Drug Administration issued a safety alert encouraging patients taking Avandia to consult with their doctor about possible treatment alternatives.
What You Should Know About Avandia
Avandia (rosiglitazone maleate) is an FDA approved drug used in the treatment of Type 2 diabetes, a serious condition affecting approximately 20 million Americans. Since its approval in 1992, the drug has been prescribed to as many as 10 million Americans, thousands of whom--according to one expert--have suffered Avandia-related heart problems.
Over the years, Avandia has been linked to various side effects including:
- Congestive heart failure, edema, and fluid retention
- Liver toxicity
- Low blood pressure
The findings published by the NEJM, however, are raising new concerns about the extent of the heart risks associated with Avandia. In an analysis of 40 studies and more than 28,000 patients, researchers found that those taking Avandia were between 30 to 40 percent more likely to suffer heart attack and heart-related death than those taking a placebo or other diabetes drug. As of May 2007, the FDA said data analyses were ongoing to confirm the risks.
The widely prescribed diabetes drug Avandia is linked to a greater risk of heart attack and possibly death, a new scientific analysis revealed, and the U.S. government issued a safety alert Monday.
The Food and Drug Administration urged diabetics taking the pill to talk to their doctors, but stopped short of forcing a sharper warning label on the drug sold by GlaxoSmithKline PLC of London.
More than 6 million people worldwide have taken the drug since it came on the market eight years ago. Pooled results of dozens of studies revealed a 43 percent higher risk of heart attack, according to the review published by the New England Journal of Medicine.
Experts said the overall risk was small and cautioned people not to stop taking the drug on their own but to talk to their doctors.
The government will take no immediate action on a label change or other measures regarding the drug, said Dr. Robert J. Meyer of the FDA's Center for Drug Evaluation and Research.
Some data suggests "that there is a potentially significant increase in the risk" but there also is risk if patients switch drugs or do not keep their blood-sugar under control, an FDA statement says.
FDA officials acknowledged that Glaxo submitted information last August indicating some increased risk from the drug but that other studies were contradictory. However, several members of Congress expressed alarm and said they would holdhearings on the safety issues.
