Actos Lawsuit Alleges Side Effects Hidden

Boston, MAAn Actos lawsuit filed by a whistleblower alleges the maker of the drug hid the risk of Actos heart failure from regulators. The lawsuit alleges that hundreds of reports linking Actos and heart failure were not made to the US Food and Drug Administration, despite such reports being legally required, possibly putting patients at risk and downplaying the risks of serious Actos side effects.

The lawsuit was filed by Helen Ge, a former medical reviewer for Takeda Pharmaceuticals, maker of Actos. As reported by Bloomberg (3/6/12), Ge alleges that Takeda did not classify "non-hospitalized or non-fatal" congestive heart failure incidents between 2007 and 2010 as serious. Serious adverse events must be reported to the FDA's Adverse Event Reporting System by drug manufacturers.

Ge filed her whistleblower lawsuit in 2010, and documents related to the lawsuit were recently unsealed. In the documents, Ge argued, "Takeda's motivation to fraudulently report and under-report the serious adverse events was driven by an economic desire to falsely enhance Actos's safety profile and to increase sales."

Despite the allegations, however, the US Justice Department did not join Ge's lawsuit, nor did 24 other states. A spokesperson for Takeda said the company "complies with all laws and regulations regarding the reporting of adverse events," (as quoted by Bloomberg; 3/6/12).

But Ge alleges that Takeda told medical reviewers to change their opinions of adverse event classifications so that Actos would appear safer than Avandia.

Meanwhile, an initial court date has been set for lawsuits that allege Actos is linked to an increased risk of bladder cancer. According to CBS News (2/14/12), lead attorneys for the consolidated lawsuits will be appointed after a March 22 status conference. Thousands of claims are expected against Takeda, alleging patients were exposed to an increased risk of bladder cancer because of the Type 2 diabetes medication.

The FDA notes that there is information about the risk of bladder cancer on the Actos warning label. However, an attorney speaking with CBS News said that given the other, safer options for treating Type 2 diabetes, patients should not be put at a risk of bladder cancer. The lawsuit further alleges that Takeda hid their knowledge about the risk of bladder cancer.