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This month the FDA has announced that the popular diabetes drug Actos (pioglitazone) is linked with an increased risk of bladder cancer. Studies have found that using the medication for more than one year puts one at risk. The warning will be added to the official Warning and Precautions section of the label for all medications containing pioglitazone. These medications include Actos, Actoplus met, Actoplus, Met XR and Duetact.
Before making this announcement the FDA looked at information from studies conducted over the last 10 years. The results showed that patients with the longest exposure to pioglitazone and those who had the highest cumulative dose of the drug were at risk. The FDA has also looked at studies in France that support these findings. In fact, France has suspended the use of the drug altogether.
Given this data, the U.S. FDA has chosen to take a more lenient approach, instead updating labeling of the medication. Instead of banning the drug, the FDA recommends that health professionals should 1.) not use pioglitazone in patients with active bladder cancer and 2.) use the drug with caution in patients with a prior history of bladder cancer. The FDA also warns patients to 1.) tell your doctor if you have symptoms like blood in the urine, frequent or urgent urination, pain while urinating or pain in back or lower abdomen and 2.) read the medication guide with pioglitazone.
Some health professionals feel the FDA has not gone far enough in ensuring patient safety with this drug. Most patients will not be aware of the increased risk of bladder cancer unless their doctor tells them. Most patients are on pioglitazone for extended periods of time and could be on it for the rest of their lives to control blood sugar. This is troubling given the fact that studies have shown the most risk in patients who have used the drug the longest and those who have had the highest cumulative doses.
If you are taking pioglitazone, do not stop taking the medication without first talking to your doctor about a suitable alternative. Stopping the drug without beginning another medication to control blood sugar could lead to dangerously high blood sugar levels.
Christi Larson, Pharm. D. is a pharmacist, author and nutrition advocate. To learn more about using supplements to help prevent cancer, see our article: The Truth About Vitamins and Cancer.
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