More Studies Point to Avandia Heart RisksJun 28, 2010 | Parker Waichman LLP
Two new Avandia studies have found a link between the controversial diabetes drug and heart risks. According to a Wall Street Journal report, the studies were published just two weeks before an important Food & Drug Administration (FDA) panel will discuss Avandia’s safety.
The first study is an update of the 2007 analysis of 47 Avandia clinical trials conducted by Dr. Steven Nissan of the Cleveland Clinic. Nissan’s earlier analysis was the first to link Avandia to a higher risk – 43% – of heart attack and stroke, and kicked off the controversy that has dogged the drug ever since. Following publication of Nissan’s 2007 analysis, a black box warning – the FDA’s strongest s safety warning – detailing Avandia’s association with myocardial ischemia was added to the drug’s labeling.
According to the Journal, Nissan’s updated analysis looks at 56 clinical studies involving 35,500 patients, including a Glaxo-funded study known as Record, and shows an increased heart attack risk of 28 percent. If the Record study is removed from the analysis, the risk of heart attacks rises to 39 percent, the Journal said.
The second study, conducted by Dr. David Graham of the FDA’s Center for Drug Evaluation and Research, found that patients in the U .S. Medicare system who took the drug may have suffered as many as 48,000 heart attacks, strokes and other problems between 1999 and 2009.
Dr. Graham’s study involved 227,500 patients, making it the largest to date. It found that patients who took Avandia were 27 percent more likely to suffer a stroke, 25 percent more likely to develop heart failure and 14 percent more likely to die compared with those who took Actos.
Both Nissan and Graham have renewed their calls for Avandia to be pulled from the market, according to report in The Washington Post.
“I’m hoping with a new administration and new leadership they will act differently. This is a defining moment for the new administration,” Nissen said.
For his part, Graham told the Post that he was not hopeful the FDA would change its Avandia stance.
“FDA, unfortunately, has not changed. It has not improved its approach to drug safety. It does not value drug safety,” Graham said.
Both Avandia studies are published online in the Journal of the American Medical Association and its sister publication, the Archives of Internal Medicine.