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Actos Diabetes Drug May Cause Bladder Cancer
On August 4, 2011, the U.S. Food and Drug Administration (FDA) issued communication saying they were informing the public that the Agency had approved updated drug labels for the pioglitazone-containing medicines (Actos) to include safety information that the use of pioglitazone (Actos) for more than one year may be associated with an increased risk of bladder cancer.
On June 15, 2011, the FDA previously stated that the use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. At that time the FDA stated that 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.
That action took a few days less than two months to be completed.
Doctors should not prescribe pioglitazone (Actos) to patients with active bladder cancer and should only prescribe Actos with caution to patients with a prior history of bladder cancer. The benefits of blood sugar control with Actos should be weighed against the unknown risks for cancer recurrence.
Meanwhile the French were more forceful in their decision making process banning the use of Actos while the Germans are not prescribing Actos for new patients.