Actos Heart Failure Underreported, According to Lawsuit
Elise Kramer | March 22nd, 2012
A complaint filed in 2010 by a former medical reviewer for drug maker Takeda Pharmaceuticals claims that the pharmaceuticals manufacturing company did not identify “non-fatal” and “non-hospitalized” Actos side effects to the Food and Drug Administration. These side effects included Actos heart failure, one of the most troubling side effects of the popular type II diabetes medication.
Lawsuit calls rate of side effects into question
Helen Ge filed her suit in the United States District Court for the District of Massachusetts after the drug maker failed to report hundreds of congestive Actos heart failure cases to the Food and Drug Administration, which keeps track of adverse side effects associated with medications. She claims that the underreported Actos heart failure complaints were directly associated with the use of the type II diabetes medication, and says that she believes that Takeda requested that medical experts alter their opinions so that the diabetes medication would appear to be safer than competing brands. This means that the rate of serious Actos side effects as reported by the Food and Drug Administration could be much lower than the real rate, meaning many more patients than previously thought could be at risk.
She says in her Actos lawsuit that when she confronted the drug makers about her concerns with their practices, they terminated her contract. Although her lawsuit was filed in June 2010, it didn’t become public until more recently, when the United States’ justice department declined to join litigation after completing its own investigation.
Takeda claims no wrongdoing
Takeda said in a statement that the drug maker “complies with all laws and regulations regarding the reporting of adverse events”. The Food and Drug Administration issued an Actos safety warning which said that Actos side effects could occur, including Actos heart failure. The risk of heart failure occurs when the heart fails to pump enough blood throughout the body, which can reduce circulation, deprive organs of oxygen, and lead to organ shutdown, which can be fatal. Ge also claims in her lawsuit that the drug maker downplayed the risk of Actos bladder cancer.
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