Approved by the FDA in 1999, Avandia (rosiglitazone) was developed to help control blood sugar in adults with Type 2 Diabetes. Avandia, as well as a related drug called Avandamet, is used by nearly seven million people worldwide.
In an article appearing in the June 14, 2007 edition, the New England Journal of Medicine details a recent analysis of clinical trials suggesting that the drug significantly increases the risk of heart attacks and cardiovascular death. The study was conducted by doctors at the renowned Cleveland Clinic and was published on May 21, 2007.
The trials compared patients taking Avandia with those not using the drug. The results indicate that Avandia users had an increase of cardiac-related deaths by 64 percent and a 43 percent increase in heart attacks.
In a Safety Alert issued May 21, 2007, the U.S. Food and Drug Administration said patients taking Avandia, especially those with heart disease or at high risk of heart attack, should talk to their doctor about the risks.
Since the drug was approved, the FDA has monitored several heart-related adverse events associated with Avandia, such as fluid retention, edema and congestive heart failure. The FDA repeatedly has updated the product’s labeling to reflect these concerns, most recently in 2006. The most recent labeling change included a new warning about a potential increase in heart attacks and heart-related chest pain in some individuals.