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Only a few months after Takada Pharmaceuticals agreed to settle thousands of Actos bladder cancer lawsuits, a new study backed by the drug maker appears to raise concerns that side effects of the diabetes drug may increase the risk of pancreatic cancer and prostate cancer.
In a study published in the Journal of the American Medical Association (JAMA) on July 21, investigators looked at data on patients who used Actos, looking for signs of association with 11 different types of cancer.
While prior studies have linked side effects of Actos to bladder cancer, the researchers in this latest study indicate that there was no statistically significant risk increase. However, indications were found that suggested there may be a potential link between Actos and prostate cancer or pancreatic cancer.
The study was conducted by researchers from the University of Pennsylvania and Kaiser Permanente, and financed by Takeda. Researchers looked at data on 193,099 people age 40 and older from 1997 to 2002. Looking at cancer diagnoses, and whether they had ever used Actos, how long they had used it, and cumulative dose.
The findings indicated that users of Actos may be 41% more likely to be diagnosed with pancreatic cancer, and 13% more likely to be diagnosed with prostate cancer.
“The increased prostate and pancreatic cancer risks associated with ever use of pioglitazone merit further investigation to assess whether they are causal or are due to chance, residual confounding, or reverse causality,” the researchers concluded.
Actos Bladder Cancer Settlement
The findings come about three months after Takeda Pharmaceuticals agreed to pay as much as $2.4 billion in Actos settlements that resolved about 8,000 lawsuits that alleged Takeda failed to adequately research the side effects of their medication or warn about the risk of bladder cancer. It was one of the largest settlements in U.S. history involving drug side effects.
The settlement was reached following several years of litigation and a number of high-profile trials, where juries returned multi-million dollar damage awards for individuals diagnosed with bladder cancer.
In April 2014, the first federal Actos trial resulted in a $9 billion jury award, after evidence was presented that indicated the drug makers destroyed evidence about the risk of bladder cancer faced by users.
While the U.S. District Judge presiding over the federal litigation later reduced the punitive damage award in the case to $37 million, she indicated that the Supreme Court needs to update rules on what is considered excessive in order to effectively deter large corporations from engaging in the type of bad behavior exhibited by Takeda and Eli Lilly.
The average payout under the terms of the Actos bladder cancer settlement is expected to be more than $296,000 per case. However, that amount could be reduced based on the individual plaintiff’s age, exposure to other cancer-causing toxins and smoking history.