Did You Know… Diabetes Drug Actos Has Been Linked To Bladder Cancer?

Many people taking the diabetes medication, Actos, may not realize that studies have linked prolonged use of Actos with bladder cancer. An FDA study released in June examines a suspected link between the prolonged use of Actos and an increased risk of bladder cancer. From the FDA communication:

“The U.S. Food and Drug Administration (FDA) is informing the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer.”

The longer a patient takes Actos, and/or the higher the dosage, the greater the increased risk of cancer. In other words, patients with the highest “cumulative dose” have the highest increased risk. The FDA also acknowledges that, after a French study pointed to an increased risk of bladder cancer, Actos has been removed from the European market pending further investigation.

The results of the French National Health Insurance Plan investigation showed that after adjusting for age, sex, and use of other anti-diabetic medications, there was a statistically significant increase in the risk for bladder cancer in patients exposed to pioglitazone compared to patients exposed to other anti-diabetic agents. According to the French investigation, a cumulative dose of greater than 28,000 milligrams and an exposure of longer than one year led to a significant increase in bladder cancer, particularly in men.

The FDA’s recommendation for patients taking Actos:

• There may be an increased chance of having bladder cancer when you take pioglitazone.
• You should not take pioglitazone if you are receiving treatment for bladder cancer.
• Tell your doctor right away if you have any of the following symptoms of bladder cancer: blood or red color in urine; urgent need to urinate or pain while urinating; pain in back or lower abdomen.
• Read the Medication Guide you get along with your pioglitazone medicine. It explains the risks associated with the use of pioglitazone.
• Talk to your healthcare professional if you have questions or concerns about pioglitazone medicines.
• Report side effects from the use of pioglitazone medicines to the FDA MedWatch program, using the information in the "Contact Us" box at the bottom of the page.

You should not stop taking this, or any, drug without consulting your health care provider. If you are currently taking Actos, you should contact your physician to evaluate and determine your treatment options.

Read More:

• FDA Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer [FDA]
• Update on ongoing European review of pioglitazone-containing medicines [European Medicines Agency]
• FDA Warns of Bladder Cancer Risks With Actos [Kristina Fiore at ABC News]

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(c) Copyright 2011 Brett A. Emison