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In June 2011, the FDA released a safety communication warning diabetes patients and their physicians about a potential link between the drug Actos (pioglitazone) and bladder cancer. At the time, the FDA based their statement on the results of an ongoing epidemiological study that showed patients taking Actos for longer than 12 months had a 40 percent increased risk of bladder cancer.

Since then, as Actos lawyers state their cases and continue to file lawsuits, it seems there remain some questions about whether or not Actos encourages the formation of bladder cancer. Now, a new article published in the Canadian Medical Association Journal adds additional evidence in favor of a link between Actos and bladder cancer.

Study Examines 2.6 Million Participants

Jeffrey A. Johnson, the Canada Research Chair in Diabetes Health Outcomes at the University of Alberta School of Public Health, was the lead author of this study. Together with his colleagues, he analyzed the results of 10 other studies on Actos and similar drugs (called thiazolidinediones). Five of the studies were observational studies, four were randomized controlled trials (RCTs), and one was a case-control study. The number of patients totaled 2.6 million, with 3643 ending up with bladder cancer.

Though each study had different results, after analyzing them all, the researchers concluded that Actos increases the risk of bladder cancer by 22 percent. The authors concluded: “The limited evidence available supports the hypothesis that thiazolidinediones, particularly pioglitazone, are associated with an increased risk of bladder cancer among adults with type 2 diabetes.”

Other Studies Show Similar Results

This study isn't the only recent research confirming the link between Actos and bladder cancer. On May 31, 2012, the British Medical Journal published a study that examined data from over 600 general practices in the United Kingdom. People with type 2 diabetes who were newly treated with drugs like Actos between January 1988 and December 2009 were included.

In total, the study examined data from over 115,000 patients, with 470 diagnosed with Actos bladder cancer. Overall, the researchers determined that patients who used Actos had an 83 percent higher risk of contracting bladder cancer than patients who never used the medication. They also theorized that the drug could lead to the formation of crystals that cause chronic bladder irritation, which could partially explain why Actos increases the risk of bladder cancer.

Actos Lawyers Likely to Use Results to Prove Their Cases

These studies support claims made by plaintiffs who have already filed Actos lawsuits. The results are likely to be used by Actos lawyers, who have blamed manufacturer Merck for failing to adequately determine safety in their own clinical trials before releasing the drug in 1999. Back then, the launch of Actos was hailed as great news for diabetes patients; however, as evidence continues to mount concerning Actos bladder cancer, the drug may soon be seen as more dangerous than effective.

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