New research has confirmed what many already suspected – that the popular diabetes drug Avandia is more likely to cause heart disease and death than other similar drugs used to treat diabetes. According to the authors of the analysis, “The effect on public health may be considerable.” In light of these findings, safety reviewers from the FDA are urging a nationwide recall of Avandia.
What’s the problem?
April 26, 2011 – In an analysis published in the British Journal of Medicine on March 17, researchers looked at the results of 16 studies that involved 810,000 users of Avandia and Actos, and found a “… modest but statistically significant increase” in the risk of certain heart conditions in patients who took the drugs. According to the studies:
- the risk of heart attack rose by 16 percent
- the risk of congestive heart failure rose 23 percent
- mortality rates rose 14 percent
“Patients should review this study with their physician to gain a better understanding of how their personal circumstances may or may not be reflected in the study, and talk to their physicians about the risks versus the benefit of taking the drug,” said Dr. Debra Wertz, outcomes research manager for HealthCore Inc., the research subsidiary of the insurance company WellPoint.
In May 2007, the U.S. Food & Drug Administration (FDA) issued a safety alert stating: “Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart related deaths in patients taking Avandia.” Three weeks later, a study published in the New England Journal of Medicine suggested that there was a 43 percent higher risk of heart attack in Avandia users.