Takeda Pharmaceuticals, the manufacturer of Actos®, has been accused of hiding information relating to additional adverse side effects of Actos. The whistleblower lawsuit was filed by Helen Ge, Takeda’s former medical reviewer.

According to the recently unveiled allegations which were originally filed in 2010, Takeda Pharmaceuticals concealed information that indicated a link between Actos and congestive heart failure. Failure to report adverse side effects of medication is a violation of federal law.

A number of lawsuits have previously been filed against Takeda Pharmaceuticals for adverse side effects allegedly caused by Actos. Consumers claim to have been diagnosed bladder cancer after taking the medication and allege that Takeda failed to adequately warn about the side effects of Actos.

Actos (pioglitazone) is a medication prescribed to patients with type II diabetes. It was introduced to the United States in July of 1999 and gained a competitive advantage over competing drug Avandia after Avandia was shown to cause adverse complications. In 2010, Actos generated $4.3 billion in sales for Takeda Pharmaceuticals.

An on-going ten year review of Actos conducted by the Food and Drug Administration revealed a linkage between Actos and bladder cancer after a number of Actos lawsuits were filed against Takeda claiming that Actos causes bladder cancer.

Medications that cause adverse side effects are required by law to be reported to the FDA’s Adverse Event Reporting System MedWatch program. The whistleblower lawsuit against Takeda alleges that from 2007 through the beginning of 2010, hundreds of cases claiming Actos causes congestive heart failure were filed but were never reported to the FDA.

An individual who reports a false claim made by an organization must be the first to report to the government and must not publicize the claim until further notice as stated under the False Claims Act. If the government recovers money, whistleblowers may be compensated in return.