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Actos maker hid safety info from FDA, whistleblower lawsuit claims

March 30th, 2012

A whistleblower lawsuit alleges that the manufacturer of the diabetes drug Actos misrepresented and hid safety information from the Food and Drug Administration. Helen Ge claims in her Actos lawsuit that Takeda Pharmaceuticals directed its staff to not classify non-hospitalized or non-fatal cases of congestive heart failure in Actos patients as serious.

Ge alleges that the company told researchers to change information on hundreds of cases of congestive heart failure between 2007 and 2010. Takeda is required to update the FDA’s adverse event reporting system with any serious incidents involving Actos, including congestive heart failure and other side effects from the drug. Ge claims that the company misrepresented its safety profile and increased sales by failing to report the cases to the agency.

Takeda is also facing mounting legal pressure from patients who claim they were injured after taking Actos. A 2011 study found that patients who use the drug for more than one year were 40% more likely to develop bladder cancer than patients on alternative drugs. The company could face as many as 10,000 lawsuits against Actos alleging that the drug causes bladder cancer.

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