Actos and Bladder Cancer

Actos, also known generically as pioglitazone, is manufactured by Takeda Pharmaceuticals.  The FDA approved its use for Type II Diabetes, in July 1999.  It is Takeda Pharmaceutical’s best selling drug, especially since problems have arisen with its competitor drug, Avandia.  The medications containing Actos include those marketed as Actos (which is pioglitazone hydrochloride), Actoplus Met (which is Actos in combination with metformin), Actoplus Met XR (which is Actos in combination with metformin – extended release), and Duetact (which is Actos in combination with glimepiride)

Warnings and Recall:

Recently France and Germany have issued a recall for Actos due to increased incidence of bladder cancer.  In the United States, the FDA has been reviewing the potential side effects of Actos.  Studies have indicated that increased risk of bladder cancer is of statistical significance, and new warnings are now required.  The FDA determined that taking Actos for 12 months or longer increases risk of bladder cancer by 40%.  The risk increases with dosage and treatment duration.  Since mid-June, 2011, the FDA acknowledged that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.  The FDA now recommends that these Actos medications not be used in patients with active bladder cancer, and used with caution in patients with a prior history of bladder cancer.   The new labeling information was approved by the FDA on or about August 4, 2011.


The FDA recommends that if anyone taking the Actos medications experiences any sign of blood in the urine or a red color in the urine or other symptoms such as new or worsening urinary urgency or pain on urination since starting pioglitazone, they should contact their healthcare professional, as these symptoms may be due to bladder cancer.

What Should You Do?

If you, or someone you know, was taking any of the above Actos medications and has been diagnosed with bladder cancer and/or has any of the above noted symptoms, you should immediately contact the healthcare professional, and you may want to contact an attorney.  Anyone suffering from bladder cancer from pioglizone medication exposure may have a right to seek compensation. Our attorneys are reviewing new cases of those injured and are ready and able to assist.  Anyone with a diagnosis of bladder cancer and/or the above-noted symptoms who has been taking any of the above noted Actos medications may contact us directly at 1-800-434-8399, or contact us through our website.