Actos Bladder Cancer Study May 2012 in BMJ

Austin Kirk

By Austin Kirk
Posted June 1, 2012


A study published this week provides further support for hundreds of Actos bladder cancer lawsuits, confirming that the more Actos you take and the longer you use the medication, the more likely you are to develop bladder cancer.

A group a Canadian researchers published an Actos study yesterday in the British Medical Journal (BMJ), which was able to show a dose-specific response between side effects of Actos and bladder cancer.

Dose-specific responses, meaning the more of the drug someone takes the stronger their chance of experiencing a certain effect, are considered signs of a strong correlation between a drug and a side effect. While prior studies have determined that the longer someone took Actos the more likely they were to be diagnosed with bladder cancer, this is the first full study to confirm that larger doses of Actos also increase the risk.

The research team was led by Laurent Azoulay, an assistant professor in the Centre for Clinical Epidemiology in the Lady Davis Institute in the Jewish General Hospital in Montreal. They used the United Kingdom’s general practice research database and looked at data on 115,727 patients who took diabetes drugs from 1988 through 2009. The mean age of the subjects was 64 and the mean follow-up period covered 4.6 years.

A total of 470 of those patients were diagnosed with bladder cancer over the course of the study, resulting in a rate of about 89.4 bladder cancer diagnoses per 100,000 person years. The average rate of bladder cancer among the rest of the U.K. population is 73 per 100,000 person years. While the rate of bladder cancer was found to be higher in general among patients with type 2 diabetes, the researchers determined that taking Actos was associated with an 83% increased rate of bladder cancer.

The researchers found that the highest rates of Actos bladder cancer were among those who took the drug for longer than two years, and the also found a statistically significant association between the rate of bladder cancer and an increased risk for those who had a cumulative dosage of more than 28,000 mg. The researchers could find no increased bladder cancer risks among patients who had taken Avandia, which is now restricted in the U.S. after being linked to an increased risk of heart attacks.

The researchers concluded:

[T]he results of this study provide evidence that pioglitazone (Actos) is associated with an increased risk of bladder cancer, whereas no increased risk was observed with the thiazolidinedione rosiglitazone (Avandia). The increased risk associated with pioglitazone became apparent after use for at least 24 months and receiving cumulative dosages greater than 28 000 mg. Such associations may have been underestimated in the previous observational studies that included prevalent users.


This study adds to the growing body of evidence in the Actos litigation, which currently involves hundreds of lawsuits filed by individuals throughout the United States who developed bladder cancer after taking Actos. The complaints allege that Takeda Pharmaceuticals, the drug maker, turned a blind eye to the increased risk of bladder cancer from Actos and failed to adequately research the side effects of their type 2 diabetes drug.

As a result of the failure to warn consumers about the risks associated with long-term use of the medication or use of high doses, financial compensation may be available through an Actos bladder cancer lawsuit for individuals who have developed this condition. Our law firm is also investigating the potential for cases on behalf of individuals who have been diagnosed with kidney cancer or prostate cancer from Actos, but both of these cases are still in the early stages of review and the science is not as well established as the risk of bladder cancer from Actos.

To review a potential case for yourself, a friend or family member, request a free consultation and claim evaluation.

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