The U.S. Food and Drug Administration (FDA) has released data from an ongoing safety review indicating a link between the long-term use of the diabetes drug Actos (pioglitazone), manufactured by Takeda, and a heightened possibility of suffering bladder cancer. The Warnings and Precautions label for pioglitazone-containing drugs will now be required to have information about this potential danger. In addition, the patient Medication Guide for these drugs will also be updated to include information on bladder cancer risks.
Results from a premeditated five-year interim analysis of a continuous, ten-year epidemiological study of pioglitazone revealed no overall heightened risk of bladder cancer. However, an increased risk of bladder cancer was detected in patients with the longest exposure to pioglitazone, and in those exposed to the highest collective dose of pioglitazone.
Recently, an epidemiological study in France found an increased risk of bladder cancer with the use of pioglitazone, causing the country to suspend the use of the diabetes medication. Moreover, Germany has suggested that new patients do not start taking pioglitazone.
About 2.3 million patients filled a prescription for a product containing pioglitazone from January 2010 through October 2010 in the United States. Although diabetes is a serious medical condition, the potential risk of bladder cancer for those who may have taken the drug for more than a year may outweigh the benefits of blood sugar control with this drug. Per 100,000 individuals, 20 per year in the U.S. are estimated to have bladder cancer, with the estimates believed to be greater for persons with diabetes.
Drug manufacturers are responsible for providing consumers with medications that are properly labeled, free of contaminants, and will not cause harm. If a consumer suffers serious injury, illness, or death from taking a medication, the drug manufacturer may be held accountable. Tennessee Actos bladder cancer attorney Gary Massey of the law firm Massey & Associates, P.C. is available to answer any questions you may have about Actos or other medications containing pioglitazone. Mr. Massey has the legal experience and resources to handle mass tort cases as well as individual personal injury and product liability cases. Call 423-697-4529 for more information.
