The FDA says it based its decision on 5-year interim data showing an increased risk for bladder cancer among those who took pioglitazone the longest and at the highest doses.
The agency is warning clinicians not to use the drug in patients with active bladder cancer and says they should use it cautiously in patients with prior bladder cancer.
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.