Safety Alerts & Recalls

What does this mean?

The FDA has told healthcare professionals to continue to follow the recommendations found in the prescribing information for Actos. If you take Actos or one of the combination products, do not stop taking your medicine unless told to do so by your healthcare professional. If you have concerns about your medicine, please talk to your doctor or other healthcare professional.

If you experience any side effects from your medicines, you can report them to the FDA MedWatch program by phone at 1-800-332-1088; by fax at 1-800-332-0178; by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787; or on the MedWatch website at www.fda.gov/medwatch

FDA Announces Safety Review of Actos (Pioglitazone) for Cancer Risk

The U.S. Food and Drug Administration (FDA) is conducting a review of results from an ongoing, ten-year study designed to determine if Actos (pioglitazone) is associated with an increased risk of bladder cancer. Findings from studies in animals and humans suggest this potential safety risk needs further study. The FDA has not concluded that Actos increases the risk of bladder cancer. The FDA's review of this safety concern is ongoing and the FDA will update the public when more information is available.

Actos contains the active ingredient pioglitazone and is used in the treatment of type 2 diabetes. Pioglitazone is also sold in combination with other diabetes medicines under the brand names Duetact, Actosplus Met, and Actosplus Met XR.

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Source: FDA
Publication Date: 2010-09-17
Last Updated: 2010-09-18

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