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Study Confirms link between Actos and Bladder Cancer

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Takeda Pharmaceutical has had their share of bad news recently with respect to their diabetes drug, Actos (pioglitazone). The FDA issued a warning last June regarding the increased risk of bladder cancer followed by a few European Markets removing Actos from the market and the filing of multiple lawsuits as a result of bladder cancer. Now, add to this string of bad news a study that confirms FDA studies and warnings – Actos has been found to have an 83% higher risk of bladder cancer.

Last week Dr. Laurent Azoulay, PhD, of McGill University in Montreal, and colleagues published an article in the online British Medical Journal (www.bmj.com) that showed patients who had taken pioglitazone at any time were found to have a 83% higher risk of bladder cancer, which translates into 74 per 100,000 person years. According to Dr. Azoulay, this risk increased for patients who had taken the drug for longer than 2yrs and whose cumulative dosage exceeded 28,000mg.

According to Dr. Azoulay, this association may have been underestimated in previous observational studies and say doctors, patients and regulatory agencies "should be aware of this association when assessing the overall risks and benefits of this therapy."