September 2, 2011

Actos (pioglitazone as the single ingredient) is a prescription medication used in the treatment of diabetes. It is used to improve control of blood sugar in adults with type 2 diabetes mellitus. Medications containing pioglitazone (pioglitazone is the single ingredient in Actos) have been filled by approximately 2.3 million patients at outpatient retail pharmacies from January, 2010 through October, 2010. 

On June 15, 2011, the U.S. Food and Drug Administration (FDA) issued a safety announcement regarding Actos to inform the public that using Actos for more than one year may be associated with an increased risk of bladder cancer. The FDA’s action was based on a five-year interim review of data from an ongoing ten-year epidemiological study that showed that although there was no overall increased risk of bladder cancer from use of pioglitazone, there was an increased risk of bladder cancer in those patients with the longest use of pioglitazone and those taking the highest cumulative dose of the drug. A recent study of pioglitazone in France suggested an increase risk of bladder cancer associated with pioglitazone, which resulted in France suspending the use of pioglitazone and with Germany recommending that new patients should not begin to use pioglitazone.

The FDA recommends that healthcare providers should not use pioglitazone in patients with active bladder cancer and that pioglitazone be used with caution in patients who have a prior history of bladder cancer, weighing the benefits of blood sugar control with pioglitazone against the unknown risks for cancer.

Patients taking pioglitazone should immediately advise their healthcare provider if they experience blood or red color in their urine, if they have an urgent need to urinate or if it is painful to urinate, or if they have pain in the back or lower abdomen.


The FDA announced on August 4, 2011 that it had approved updated labeling information for drugs containing pioglitazone to include safety information that the use of pioglitazone for more than one year may be associated with an increased risk of bladder cancer and recommending that healthcare providers not use pioglitazone in patients with active bladder cancer and that healthcare providers use pioglitazone with caution in patients with a prior history of bladder cancer. The updated label also recommends that patients taking pioglitazone contact their healthcare providers if they experience any sign of blood or red color in their urine or new or worsening urinary urgency or pain when urinating since starting pioglitazone.


If you were taking Actos or another medication containing pioglitazone and developed bladder cancer or worsening bladder cancer, visit our website to be connected with medical malpractice lawyers who may be able to assist you with your possible claim. You may also contact us toll free 800-295-3959.

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