The U.S. Food and Drug Administration (FDA) is informing the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. 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.
This safety information is based on FDA's review of data from a planned five-year interim analysis of an ongoing, ten-year epidemiological study. The five-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.
FDA is also aware of a recent epidemiological study conducted in France which 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 to start pioglitazone in new patients.
For more information, please visit: Actos ► Drug Safety and Availability > FDA Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer
European Medicines Agency - News and press release archive - Update on ongoing European review of pioglitazone–containing medicines ►
European Medicines Agency - News and press release archive - Update on ongoing European review of pioglitazone–containing medicines
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