The diabetes drug pioglitazone (Actos) increases the risk of bladder cancer in people who take it for a year or longer, the Food and Drug Administration announced yesterday. The warning applies to all drugs containing pioglitazone, including Actoplus Met, Actoplus Met XR, and Duetact.
The FDA said an ongoing study involving more than 193,000 people 40 or older with type 2 diabetes found that those who took Actos for more than a year had a 40 percent higher risk of developing bladder cancer. France banned the drug last week after a study that followed 1.5 million people with diabetes also found an increased risk of bladder cancer, particularly in men.
Signs of bladder cancer include blood or red color in your urine, urgent need to urinate or pain while urinating, and pain in your back or lower abdomen. Contact your doctor if you experience any of those symptoms.
The FDA has not banned Actos or the combination pills that contain it, but said the medications should not be used by people who have previously had or currently have bladder cancer.
Bottom line: Our medical advisors say that people with diabetes should use Actos—which has also been linked to heart failure and bone fractures—only as a last resort, which means only if all other options have failed. And it should never be used to prevent the disease in people with “pre-diabetes.”
If you’re on Actos, ask your doctor if it’s really necessary and if you should switch to another drug. We recommend the drug metformin, either alone or with glipizide or glimepiride, for most people with type 2 diabetes, combined with a healthy diet, exercise, and losing excess weight.
FDA Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer [U.S. Food and Drug Administration]