A 2010 study, published in the American Heart Association’s journal Circulation, found that the risk for heart attacks was the same for Actos as it was for Avandia. According to the study, patients taking Actos or Avandia were 4 percent more likely to experience heart attacks. The study included over 36,000 patients with an average age of 54. This study was conducted over 33 months, including 14 months of treatment on either medication. Among the patients, 602 Avandia users and 599 Actos users suffered a heart attack, heart failure, or died. Even more concerning, there were 217 deaths in each group. Despite these alarming numbers, some found the results of this study to be inconclusive.
Following the study, Takeda was quick to reject the Actos-heart attack link. A Takeda spokesperson, Hisahi Tokinoya, explained “Actos studies, conducted over the past 11 years in more than 20,000 patients, show no evidence that Actos was associated with an increased risk of heart attack, stroke, or death.”
Although there has been a black box warning for heart failure since 2007, Actos has never updated its warnings as it relates to the risk of heart attacks.
Questions regarding increased risk for heart attacks for Actos users once again re-emerged in a 2012 lawsuit by whistleblower Dr. Helen Ge. Dr. Ge was a former medical reviewer for Takeda. The Actos whistleblower lawsuit (U.S. ex rel. Helen Ge v. Takeda Pharmaceutical Co., 10-cv-11043, U.S. District Court, District of Massachusetts (Boston)) alleged that Takeda knew about instances of Actos heart attacks, but failed to report these events due to financial motives. Dr. Ge further alleged that on multiple occasions, Takeda “improperly instructed” its medical reviewers to “change their professional opinion regarding adverse event classifications and assessments.” According to Dr. Ge, her contract was terminated as she continued to protest this alleged practice. Unfortunately, in November 2012, Dr. Ge’s lawsuit was dismissed due to a pleading technicality before the merits of Dr. Ge’s claims were determined. Many questions remain as to whether Takeda continues to underplay the risk of heart attacks for Actos users.
If you or a loved one was taking Actos and suffered a heart attack, you may have a legal claim against Takeda. You can contact our law firm for a free consultation at (610) 941-4204 or on our website: www.pbmattorneys.com