Interest in litigation over the diabetes drug Actos heightened on June 16, 2011 when the FDA required a label change (following France and Germany’s action of pulling the drug from the market) for the drug to reflect that taking the drug for more than a year causes a 40% increase in the risk for bladder cancer. The bladder cancer risk was highest in those receiving a cumulative dosage of 28,000 mg or more during the study period. Bladder cancer is an aggressive cancer that affects 70,000 Americans a year, with 17,000 dying from the disease. The evidence was bad enough that Dr. Harlan Krumholz, a Yale School of Medicine professor, stated that “(Actos) should only be considered… after patients have exhausted all other options.”
Additionally, on August 17, 2011, the website EHealthMe released a study regarding the side effects of taking Actos and the bladder cancer risk. According to the report, 22,512 subjects reported side effects when taking Actos and 0.22% have bladder cancer. About 43% were using Actos between 2-5 years before having bladder cancer with the next largest group—around 29%–having used Actos between 1-6 months.
Earlier, in 2007, the FDA requested that Actos boxes be given a black box label, the strongest FDA-requested label change that can be added to a drug. This was due to the risk of serious cardiovascular events caused by the drug, such as heart attacks and heart failure. A study was released on August 24, 2010 showing that the drug was just as dangerous as Avandia in terms of increasing risks of cardiovascular events. This research included reviewing adverse event reports which found cases of significant weight gain and edema—warning signs of heart failure—and even death. Consequently, lawsuits were filed in August of 2011.
Patients have been able to support their allegations with a litany of other evidence. This includes a 2005 Proactive study that demonstrated a higher percentage of bladder cancer cases in patients receiving Actos, findings in animal model carcinogenicity studies and other pre-clinical evidence, the FDA three-year study of livers in patients taking Actos showing increase risk of bladder cancer, the actions in France and Germany suspending use of Actos, and reports by the American Diabetes Association that recognized an association between Actos and bladder cancer.