On September 17, 2010, the FDA notified healthcare professionals and current patients of a terrible and life-threatening side effect of Actos use: bladder cancer. The FDA stated it was conducting a “safety review” after Takeda submitted results at the half-way mark of an on-going, ten year epidemioloical study, running from January 1, 1997 through April 30, 2008. The manufacturer reported no statistically significant association between Actos and bladder cancer, yet the FDA did determine that the study indicated an increased risk in those using Actos for more than one year.

Less than nine months later, in June 2011, the FDA, based on an independent French study, announced that the “use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer” and required another label and Warnings and Precautions update. The French study following 1.5 million patients enrolled in the French National Health Insurance Plan for four years (2006-2009) and found a statistically significant increased risk of long-term use (more than one year) and bladder cancer and an increased risk of higher cumulative dosing (28,000 mg or greater) and bladder cancer.  The European community took this study seriously and acted immediately. John Gever, Senior Editor at MedPage Today, reported on June 10, 2011, that the French study was completed on a Tuesday, use of Actos in France was suspended the following Thursday, and by that Friday, Germany had followed suit and also halted use in new patients.

After an initial study revealed a link between Actos and bladder tumors in rats, the FDA required a more comprehensive, ten-year study to be completed.  According to Kristina Flore, staff writer for MedPage Today and ABC News, at the conclusion of this study, patients on Actos “for more than a year had a 40% increased risk of bladder cancer compared to those who never took it.”  In June 2011, both France and Germany suspended the prescription of Actos by doctors to new patients.  The British Medical Journal (BMJ), in an article dated May 31, 2012, published research that shows patient-risk of bladder cancer while taking Actos actually doubles.

Have you developed bladder cancer during or after Actos use?  Any individual or the relative of an individual who has suffered due to Actos’ side effects is permitted to file a lawsuit.  The lawyers can can help you determine whether you are qualified to seek compensation. You may be eligible to seek reimbursement for medical expenses, compensation for pain and suffering, and punitive damages (compensation granted for losses suffered).  If you need further information about the harmful side effects of Actos or legal advice concerning personal injury matters, we invite you to contact us or to fill out our form on this website for a free case evaluation.