Actos diabetes drug maker faces trial over cancer claims
Takeda Pharmaceutical Co., maker of diabetes drug Actos, is facing several lawsuits that claim the drug caused bladder cancer and other health complications in some patients.
According to court records, more than 3,000 suits are being brought to light.
Bladder cancer and heart problems
In 2011, a company-sponsored study reviewed by the FDA found that some patients using Actos had a higher risk for developing bladder cancer or heart problems. As a result, the drug was pulled from shelves in Germany and France the same year.
But Takeda officials are defending the drug's safety, noting that the FDA found it to be "a safe and effective" drug.
“We empathize with the plaintiffs but believe that Takeda acted responsibly with regard to Actos,” D’Lesli Davis, a Takeda lawyer, said in an e-mailed statement. “Studies do not establish a causal link between Actos and bladder cancer.”
According to court filings, Takeda researchers downplayed information about Actos risks before the drug was available in the US, which may have mislead regulators who approved the drug.
In a whistleblower event, former Takeda reviewer Helen Ge said the company failed to disclose information about Actos and its risks of congestive heart failure.
“These events were not properly identified or reported in the FDA’s safety database,” Ge said. “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.”