FDA Safety Alert for Actos®

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FDA Safety Alert for Actos®

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In August 2011, the U.S. Food and Drug Administration (FDA) approved updated drug labels for the pioglitazone, also known as the drug Actos®. The new label means that medicines containing pioglitazone will include safety information that the use of pioglitazone for more than one year may be associated with an increased risk of bladder cancer.

The August label approval follows a June 2011 alert by the FDA regarding pioglitazone. That alert informed the public that the potential increased risk of bladder cancer will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. Further, the possible increased bladder cancer risk should also be part of the patient Medication Guide.

The FDA’s alert was based on data from an ongoing ten-year epidemiological study. The study, conducted by the drug’s manufacturer (Takeda) was based on 193,099 patients with diabetes. The five-year results from this study showed an increased risk of bladder cancer was noted among patients with the longest exposure and highest cumulative dose to pioglitazone. The bottom line is that as compared to never being exposed to pioglitazone, a patient who took pioglitazone therapy longer than 12 months had a 40% increase in risk of bladder cancer. The FDA is also aware of a recent epidemiological study in France (based on 1.5 million patients with diabetes) which suggests an increased risk of bladder cancer with pioglitazone. Because of the French study, France has suspended the use of pioglitazone and Germany has recommended not starting pioglitazone in new patients.

The FDA recommends that health professionals not prescribe Actos® in patients with active bladder cancer. They should also use caution in 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. If you are currently taking Actos®, the FDA recommends that health professionals counsel their patients to report any signs or symptoms of blood in the urine, urinary urgency, pain on urination, or back or abdominal pain, as these may be due to bladder cancer.

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