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Whistleblower Claims Maker of Actos Hid Adverse Events From The Feds

Posted on April 5, 2012

A medical reviewer who worked for the manufacturer of the drug Actos, has filed a whistleblower lawsuit claiming that the drug company knowingly hid adverse events associated with the embattled diabetes drug.

The lawsuit alleges that Takeda Pharmaceuticals North America, Inc., concealed Actos heart failure risks. The suit goes on to contend that as a result of the concealment, doctors prescribed the drug more than they would have had they known the risks, which ultimately cost federal and state health programs hundreds of millions of dollars.

The whistleblower alleges that Takeda didn’t properly report all congestive heart failure adverse events related to Actos to the U.S. Food and Drug Administration (FDA). Between 2007 and 2010, the suit alleges that the Japanese drugmaker didn’t count hundreds of reports of non-hospitalized and non-fatal congestive heart failure cases as “serious” adverse events — thus, avoiding having to report them as such to the FDA.

The whistleblower, who worked for Takeda in 2008, alleges her contract was terminated when she complained about the underreporting of the congestive heart failure events. The suit also alleges that Takeda attempted to sway medical reviewers’ opinions concerning the potential dangerous side effects of the drug.

In June of 2011, Takeda stopped selling Actos in Germany and France. Both the FDA and the European Medicines Agency have issued warnings about the drug’s possible link to bladder cancer.

Takeda will not comment on the allegations since the lawsuit is still pending.

The Florida Actos attorneys at Farah & Farah will be keeping close tabs on this lawsuit as it evolves. If you suspect you are suffering from congestive heart failure or bladder cancer linked to Actos use, please give us a call at (800) 533-3555 to learn more about your legal rights and options. The call is free and confidential.

Sources: http://www.law360.com/productliability/articles/317049/takeda-hid-diabetes-drug-s-heart-risks-ex-reviewer-says;http://www.prweb.com/releases/2012/3/prweb9296926.htm