In September 2010, the FDA recognized the potential link between Actos and bladder cancer. In the Safety Alert, the FDA cited a ten-year long epidemiological study of Actos which first identified the link to bladder cancer.
If you took Actos and developed bladder cancer, contact us to speak to an attorney for a free confidential evaluation. We are helping people nationwide who have suffered this side effect. Please call 800-481-1615 or contact us online
Interestingly, Actos manufacturer Takeda submitted a study to the FDA which failed to find a link to bladder cancer. However, the FDA looked at how long people were on Actos as well as the total amount they ingested and found an "increased risk of bladder cancer was observed among patients with the longest exposure to Actos, as well as in those exposed to the highest cumulative dose of Actos."
In June 2011, the FDA issued a recommendation entitled "Actos: Potential Increased Risk of Bladder Cancer" which restated their concerns from September of 2010. It repeated their findings from September 2010 and instructed persons with symptoms that may be indicative of bladder cancer to talk to their doctor.
In August 2011, the FDA Center for Drug Evaluation and Research approved a Label Change for Actos that included a warning to those taking Actos for more than 12 months about the 40% per year increased risk of developing bladder cancer.
