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FDA Investigating Link Between Actos and Bladder Cancer

On September 17, 2010, the FDA announced it is conducting an ongoing safety review of the diabetes drug, Actos (pioglitazone). The FDA notified healthcare providers and patients that it is reviewing data from an "ongoing, ten-year epidemiological study designed to evaluate whether Actos is associated with an increased risk of bladder cancer." While the FDA noted it had not concluded their was a link between Actos and an increased risk of bladder cancer, it stated that studies in animals and humans tends to suggest that this is a potential safety risk of the drug.

The FDA in its announcement advised doctors to continue to follow the recommendations in the drug label when prescribing Actos and told patients to continue taking the drug unless advised otherwise by their physician. The FDA also encouraged patients and healthcare providers to report adverse events or side effects related to the use of Actos to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
Categories: FDA, Actos, bladder cancer

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