The FDA notified the public in June 2011 that using Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.
The FDA also directed that information about the risk of bladder cancer would be added to the “Warnings and Precautions” section of the label of pioglitazone-containing medicines. The patient guide for these medicines would also be revised to include information on the risk of bladder cancer, the FDA said.
The FDA advised doctors to not prescribe pioglitazone to patients who have active bladder cancer and to “use pioglitazone with caution” in patients who have a history of bladder cancer.
France suspended the use of Actos after a French National Health Insurance Plan study determined that pioglitazone increased patients’ risk of developing bladder cancer, and Germany has recommended that Actos not be prescribed to new patients.
The FDA says it continues to evaluate data from an ongoing 10-year epidemiological study of pioglitazone and will conduct a comprehensive review of the French study. The FDA will update the public when more information becomes available.
Meanwhile, The Driscoll Firm, LLC, is actively litigating lawsuits on behalf of diabetes patients who developed bladder cancer after taking pioglitazone in Actos, Actoplus Met, Actoplus Met XR and/or Duetact. Our firm continues to review and accept Actos cases.