The Food and Drug Administration has issued a warning that the diabetes drug Actos may increase a patient’s risk of developing bladder cancer. The agency stated that it plans to update the patient medication guide for Actos in order to alert patients that they may be at risk of developing bladder cancer by using the drug.
The FDA’s Actos warning was based on preliminary results from a 10-year study examining the link between Actos and bladder cancer. The study found that patients who take Actos for more than one year or who are treated with the highest dose of the drug were at an increased risk of developing bladder cancer.
The agency also noted the results of a French study that also found a link between Actos and bladder cancer. Health officials in France and Germany have ordered an end to sales of Actos in those countries based on the results of the study. FDA officials have not announced plans to recall Actos in the US.
The FDA has advised doctors not to prescribe Actos to patients with active bladder cancer and to use caution in prescribing the drug to those with a prior history of the disease. Patients who develop symptoms of bladder cancer—including blood in the urine, an urgent need to urinate, back pain and lower abdominal pain—were advised to talk with their doctor as soon as possible.