eMedicineLive

A new update by the Food and Drug Administration (FDA) has warned the physicians and the consumers that continued use of Pioglitazone, an anti-diabetes medicine, for more than one year may be linked with an increased risk of bladder cancer. The FDA has announced that information on the drug;s label as well as the patient medical guide will soon be revised to include the link between the medicine and bladder cancer. Pioglitazone is an anti- diabetic drug used in the treatment of type II diabetes. It attaches on the insulin receptors on the cells and make them more responsive to insulin. It also reduces the production of glucose by the liver. According to the FDA, almost 2.3 million patients in the U.S. used pioglitazone last year.

The announcement by the FDA comes close on heels of similar announcements by the German and French regulators who have recommended that pioglitazone should not be started on new patients and are suspending sales of the medicine. Though the FDA is not planning to ban the medicine right now, it has issued an advisory recommending that pioglitazone should not be used in patients with active bladder cancer. It should be used with caution in patients with a history of bladder cancer after the physician has carefully weighed the benefits of the medicine in controlling diabetes against increased chances of a recurrence of bladder cancer.

It has also urged the patients to go through the pioglitazone medication guide carefully and report to the doctor immediately any signs of blood in the urine, urinary urgency, pain in the abdomen or back and any pain during micturition, as these signs may be indicative of bladder cancer. A case control study of 193,000 diabetic patients of the Kaiser Permanente Northern California (KPNC) health plan was done to analyze the long term risk of bladder cancer. It was found that patients taking pioglitazone for more than 1 year had 40% more chances of developing bladder cancer as compared to people who had never taken the medicine.

The FDA has forwarded its recommendations based on the findings of this study as well as on an ongoing 10 year observational cohort study. It says that therapy with pioglitazone for more than 1 year was associated with 27.5 excess cases of bladder cancer per 100,000 person-years follow up.