In its announcement, the French drug agency AFSSAPS said that a French cohort of some 155,000 patients with diabetes who were exposed to pioglitazone, when compared with a nonexposed diabetic cohort, showed a statistically significant association between exposure to the drug and the incidence of bladder cancer.
In September 2010 the FDA said it was following a 10-year epidemiological study of the association. Interim results showed an increased risk among patients with the longest exposures and the highest cumulative doses of Actos.
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