Not enough evidence to link diabetes drug to bladder cancer, the company claims

A judge has thrown out the jury’s verdict in a case between Japanese drugmaker Takeda and a US man who claims that the company’s drug caused his bladder cancer.

On 29 April, a jury decided in favour of Jack Cooper, saying that the company didn’t do enough to warn him that Actos (pioglitazone) would increase his risk of bladder cancer. The company was ordered to pay Cooper $6.5 million (£4.2 million) in damages.

However, Takeda appealed to the judge, claiming that there was not enough evidence to directly link Cooper’s cancer to the drug. The judge agreed and nullified the jury’s decision.

The case is the first of over 3300 that have been compiled against the company over bladder cancer claims. In 2011, after reviewing safety data on pioglitazone, the US Food and Drugs Administration (FDA) highlighted a possible but unproven link between the drug and increased risk of bladder cancer. The FDA recommended it not be prescribed to patients with active bladder cancer or history of the disease.

Takeda maintains that it has acted responsibly regarding the safety of Actos, disclosing safety data to regulatory authorities and warning about other side effects, such as heart problems.