The latest report by the Institute for Safe Medication Practices raises added concerns about the prevalence of bladder cancer among people taking the diabetes drug Actos. The widely prescribed brand name drug manufactured by Takeda Pharmaceuticals is used to manage blood sugar levels in adults with Type 2 diabetes.
The Institute for Safe Medication Practices is a non-profit watchdog group focused on prevention of medication errors and side effects. According the ISMP’s QuarterWatch report, the Food and Drug Administration has received 1,025 reports of bladder cancer in which Actos was the primary suspect drug since January 2011. The FDA received 235 new cases in the first quarter of 2012 alone, the report said.
The voluntary adverse event reports are an important part of the FDA’s system of monitoring the safety of prescription drugs. But submission of reports doesn’t prove that a drug caused a disease or side effect in an individual patient.
The surge in reports of bladder cancer among people taking Actos comes after an FDA safety warning last year that use of the diabetes drug for more than a year may be associated with an increased risk of bladder cancer. The FDA based the safety warning on an analysis of five years of interim patient data from an ongoing 10-year study by the University of Pennsylvania designed to evaluate whether Actos is associated with an increased risk of bladder cancer.
According to the FDA, the preliminary results suggested an increased risk of bladder cancer among patients who had been taking Actos for two years or longer and among those exposed to higher dosages of the medication.
The FDA ordered the drug maker to add additional warnings about the cancer risk in the patient medication guide.
The lawyers of The Driscoll Firm, LLC, are committed to helping people who have been harmed by unsafe drugs and by pharmaceutical manufacturers that put profits ahead of patient safety. The Driscoll Firm, LLC, is representing a number of patients harmed by Actos. In treating your diabetes, you should not have to put yourself at risk of developing bladder cancer.
