Study Links Actos and 40% Higher Risk of Pancreatic CancerJuly 22, 2015 — A 10-year study of the diabetes drug Actos (pioglitazone) has found a 40% increased risk of pancreatic cancer, but no evidence linking it to bladder cancer.

The study was published by the Journal of the American Medical Association (JAMA) and funded by Takeda Pharmaceuticals, the maker of Actos.

The 10-year findings came from an analyses involving 236,000 adults in California, as part of an observational follow-up requested by the FDA.

Patients on Actos were 41% more likely to be diagnosed with pancreatic cancer and 13% more likely to develop prostate cancer. However, researchers cautioned that it is too early to draw a conclusive link between Actos and cancer:

“There was no statistically significant increased risk of bladder cancer associated with pioglitazone use. … The increased prostate and pancreatic cancer risks associated with ever use of pioglitazone merit further investigation.”

People with diabetes often have chronic inflammation in the pancreas (pancreatitis), which is a risk-factor for pancreatic cancer. People with advanced diabetes might also be more likely to be prescribed Actos.

In 2011, the 5-year analysis showed a 40% increased risk of bladder cancer among patients on Actos for more than two years. In response to that preliminary information, the FDA issued a Safety Communication that sparked a wave of litigation.

Over 5,000 lawsuits were filed in federal court and Takeda was accused of destroying evidence linking Actos and bladder cancer. In 2014, a jury in Louisiana hit Takeda with a record-setting $9 billion jury verdict. Earlier this year, Takeda offered $2.4 billion to settle the “vast majority” of lawsuits, or nearly $300,000 per plaintiff.

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