The FDA has confirmed an increased risk of bladder cancer from pioglitazone, a type-2 diabetes drug sold under brand-names like Actos, Actoplus Met XR, Duetact, and Oseni.
The agency cited a study published in March that found a 63% increased risk of bladder cancer for Actos, based on 13 years of data from 145,000 people with diabetes.
Nearly 9,000 lawsuits were filed after the FDA initially updated warning labels on Actos to include bladder cancer in 2011.
Around 1,300 cases remain in Multi-District Litigation (MDL No. 2299) in the Western District of Louisiana under Judge Rebecca Doherty, where a jury delivered a record-setting $9 billion verdict in 2014.
The verdict was cut to $37 million for Terrence Allen, a man who took Actos from 2004 until he was diagnosed with bladder cancer in 2011. His lawyers say Takeda had evidence of the risk as early as 2004 and destroyed documents.
One year after the verdict, Takeda Pharmaceuticals resolved most Actos lawsuits with a $2.37 billion settlement, for an average payout of $296,000 per case.
France and Germany banned Actos after the first studies linked it to bladder cancer in 2011. In 2012, a study in the British Medical Journal found an 83% increased risk of bladder cancer from Actos.
Last year, Takeda published the results of a company-funded 10-year study involving 200,000 people with diabetes. The 5-year results showed a 40% increased risk of bladder cancer from Actos. The 10-year results showed a 41% increased risk of pancreatic cancer and a 13% increased risk of prostate cancer.
The FDA asks patients to contact their health care professional if they experience any of the following symptoms of bladder cancer:
- Blood or a red color in the urine
- New or worsening urge to urinate
- Pain when urinating
Source: FDA Drug Safety Communication: Updated FDA review concludes that use of type 2 diabetes medicine pioglitazone may be linked to an increased risk of bladder cancer