Ongoing Safety Review Data for Actos (pioglitazone) Reveals Possibility of Bladder Cancer

Diabetics have enough to worry about without a medication causing them an increased chance of suffering bladder cancer being added to the mix. Unfortunately, Actos (pioglitazone) has been found to do just that for patients who use the medication on a long-term basis.

The U.S. Food and Drug Administration (FDA) released data from a five-year provisional analysis of a 10-year epidemiological study of Actos (pioglitazone). They found there to be no complete heightened risk of bladder cancer with pioglitazone usage. But what they did find is an increased risk of bladder cancer for patients with the longest exposure to pioglitazone, and also in patients with the highest total dose of pioglitazone.

Products containing pioglitazone are on the market as a single-ingredient product under the brand-name Actos. They are also available in combination with metformin (Actoplus Met, Actoplus Met XR) and glimepiride (Duetact). People with type 2 diabetes mellitus use this medication along with diet and exercise to help better control their blood sugar. About 2.3 million people filled a prescription for a product with pioglitazone within the short period of 10months between January 2010 and October 2010.

Although information about the bladder cancer risk will be added to the Warnings and Precautions labels of pioglitazone-containing drugs as well as the patient Medication Guide for these medications, the FDA is aware that France has put a hold on the use of pioglitazone and Germany has suggested that new patients do not start using pioglitazone products.

At this time, the FDA’s recommendation to healthcare professionals is to refrain from using pioglitazone in patients who have bladder cancer and to be extra cautious when giving patients with a history of bladder cancer pioglitazone. The FDA calculates that the benefits of blood sugar control with pioglitazone should outweigh the unknown risks for cancer returning.

As drug injury lawyers in Philadelphia here at The Beasley Firm, we know what your health is worth. For decades, we have stood up against negligent drug manufacturers who failed to place safe medications on the market, causing trusting consumers to suffer injury, illness, and even death. To find out how our experienced legal and medical teams may be able to help you obtain compensation for damages caused by a dangerous medication, call for a free, no obligation and confidential consultation.