News On Actos

Recently, French and then German regulators have withdrawn approval for Actos therapy in type 2 diabetes owing to a small but significantly increased risk of urinary bladder cancer noted in 1 study in patients taking the drug for longer than 5 years. Japanese regulators plan no action against Actos at present. Suggestions of such a link to bladder cancer have appeared in various data sets elsewhere, including the United States. These findings have shown small and not significant increases and so the matter has been under study by the US FDA, which has been aware of the issue since last summer. AACE supports the present investigation of the data by the US FDA and awaits their conclusions and recommendations. Until that time, we recommend that no change in diabetic medications be undertaken at present without a thorough understanding of the risks and benefits of any change in light of the individual clinical situation at hand. Discussions between physicians and patients should be the basis for any and all therapeutic decisions, including those surrounding the continued use of Actos.

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