Washington, DCOn September 17 the US Food and Drug Administration (FDA) announced that the diabetes drug Actos (pioglitazone) may be linked to bladder cancer. The agency said preliminary evidence suggests this relationship warrants further study.
The agency also said it has not concluded that pioglitazone increases the risk for bladder cancer and urged patients taking the medication to continue to do so unless told otherwise by their healthcare professional. Actos, made by Takeda Pharmaceuticals North American Inc., is taken by adults with type 2 diabetes mellitus, as an adjunct to exercise and diet to improve glycemic control.
Actos, along with Avandia (rosiglitazone), are the only FDA-approved medications in the thiazolidinedione class. Pioglitazone is believed to be a safer option for patients and the FDA is currently deliberating whether to take rosiglitazone off the market or to add restrictions and label warnings because of its cardiovascular risks.
The FDA said an analysis of data collected during a 5-year period from an ongoing 1o-year observational study, which was conducted by the manufacturer, showed overall there was no significant association between use of Actos and increased risk of bladder cancer among diabetes mellitus patients. However, those who used Actos were 20 percent more likely to be diagnosed with the cancer, and the FDA acknowledged the risk of bladder cancer was found significantly higher among those who had either been using Actos for more than two years or had had a highest accumulative dose of this medication.
Type 2 diabetes mellitus is considered a disease that is preventable in most cases. The disease affects an estimated 20 million American men and women.