A recent study comparing the cardiovascular risks of rival Type 2 diabetes drugs has shown Actos to be safer than Avandia. The study, conducted by government scientists, found that Avandia increased the risk of heart attack, stroke, heart failure and death.
The co-author of the study, Dr. David J. Graham, is concerned that officials at the FDA are blocking the manuscript from being submitted to the Journal of the American Medical Association (JAMA) for publication. Dr. Graham, Associate Director of the FDA’s Office of Drug Safety, expressed his concerns in an email sent to FDA Commissioner Dr. Margaret Hamburg on May 28, 2010. The FDA denies attempting to suppress the study.
The study shows that Avandia use increases the risk of stroke by 27%, the risk of heart failure by 25%, the risk of death by 13%, the risk of acute myocardial infarction (AMI) or death by 11% percent, the risk of AMI, stroke, or death by 14 %, and the risk of AMI, stroke, heart failure or death by 17%.
The authors conclude that the impact of the increased risks is “substantial.”
“The national impact has been undoubtedly much greater because our estimate does not account for (Avandia) use among patients under the age of 65 years, where an estimated 61.6 percent of (Avandia) use occurred through mid-2009. This would place (Avandia) in the same category as (Vioxx)with respect to magnitude and severity of population harm.”
In July, an FDA advisory panel will meet to review Avandia safety. Critics of the drug demand an Avandia recall. While continuing to claim its diabetes drug is safe, GlazoSmithKline is paying millions of dollars to settle Avandia lawsuits. Settlements are being paid in cases claiming the Avandia caused heart attack, stroke, heart failure and death.