Updated Drug Label Approved for Pioglitazone after Safety Review

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FDAlogoThe FDA recently approved updated drug labels for pioglitazone (Actos) and other pioglitazone-containing medicines (in combination with metformin, Actoplus Met and Actoplus Met XR; and with glimepiride, Duetact) to include safety information that the use of pioglitazone for more than 1 year may be associated with an increased risk of bladder cancer.

The updated drug labels recommend that health-care professionals should not use pioglitazone in patients with active bladder cancer, and use pioglitazone with caution in patients with a prior history of bladder cancer. The new labels also recommend that patients should contact their health-care professional if they experience any sign of blood (or a red color) in the urine or other symptoms such as new or worsening urinary urgency or pain on urination since starting pioglitazone, as these may be due to bladder cancer.

Pioglitazone is used along with diet and exercise to improve control of blood sugar in adults with type 2 diabetes mellitus. From January 2010 through October 2010, approximately 2.3 million patients filled a prescription for a pioglitazone-containing product from outpatient retail pharmacies

Safety Announcement

The FDA had issued a safety announcement in June to inform the public about the possible association between pioglitazone use and bladder cancer risk. The safety information was based on FDA’s review of data from a planned 5-year interim analysis of an ongoing, 10-year epidemiologic study. The 5-year results showed that although there was no overall increased risk of bladder cancer with pioglitazone use, an increased risk of bladder cancer was noted among patients with the longest exposure to pioglitazone, and in those exposed to the highest cumulative dose of pioglitazone.

The FDA safety announcement also mentioned an epidemiologic study conducted in France that suggests an increased risk of bladder cancer with pioglitazone. Based on the results of this study, France has suspended the use of pioglitazone and Germany has recommended not starting pioglitazone in new patients.

FDA will continue to evaluate data from the ongoing 10-year epidemiologic study. The Agency will also conduct a comprehensive review of the results from the French study. FDA will update the public when more information becomes available. ■




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