In 2012, an article was published in Urology titled “Association between pioglitazone and urothelial bladder cancer.” by Y. Barbalat et al. that aimed to “present the current literature reporting the association between pioglitazone and bladder cancer.”  To be clear, “pioglitazone” is the chemical name for the diabetes drug, Actos, manufactured by Takeda Pharmaceutical Co. and Eli Lilly & Co.

The team writes “The U.S. Food and Drug Administration (FDA) has recently informed the public that the use of pioglitazone may be associated with an increased risk of bladder cancer. 3 The European Medicines Agency (EMA) released a similar statement 4 and some European countries, such as France and Germany, have already removed pioglitazone from the market. Clearly, this association has many implications from an oncologic and clinical standpoint.”

One study the team cites was conducted by Suzuki et al., finding “pioglitazone produced calcium-containing urinary solids, which were associated with increased urothelial cytotoxicity, necrosis, and regenerative proliferation.”  Another study cited found “pioglitazone is a PPARγ ligand used in the treatment of DMII and was found to have carcinogenic activity toward the male rat bladder.”

Concerning human subjects trials, the paper notes first a study evaluating 5,238 patients receiving Actos that found “trend toward more bladder tumors” but failed to reach statistical significance.  Another study evaluating over 30 thousand Actos users of 193 thousand members of a particular health insurance plan found “Among men only, there was a significant increase in the relative hazard of bladder cancer with >24 months of exposure (HR 1.6; 95% CI 1.2-2.3) and with a >28,000 mg cumulative dose (HR 1.8; 95% CI 1.2-2.6).”  That means that in men who used Actos for longer than two years, the risk for bladder cancer was raised by 60%, and in men who took more than 28,000 mg of Actos over time, the risk for bladder cancer was raised by 80%, nearly double the risk for bladder cancer compared with non-users.

Overall, and thankfully, the team notes that “Ninety-five percent of cancers diagnosed among pioglitazone users were detected at an early stage” and comments that “the health benefits of pioglitazone may outweigh the risk of bladder cancer associated with this drug. Nevertheless, urologists should be aware of this possible risk, especially when managing diabetic patients with hematuria or other risk factors for bladder cancer.”

Due to the fact that a number of people have used Actos unaware of the connection the drug has with bladder cancer, a number of Actos bladder cancer lawsuits have been filed.  If you or a loved one used Actos and suffered bladder cancer as a result, you too may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Actos lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

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