European Medicines Agency Finalizes Pioglitazone Review

European Medicines Agency Recommends New Contra-indications and Warnings for Pioglitazone to Reduce Small Increased Risk of Bladder Cancer

The EMA issued a Press Release on July 21st stating that pioglitazone-based medicines “remain a valid treatment option for…patients who cannot be adequately treated by other treatments and who will benefit from treatment with pioglitazone” but confirming that there is an “increased risk of bladder cancer in patients taking these medicines.” Prescribers are advised not to use these medicines in patients with current or a history of bladder cancer or in patients with uninvestigated macroscopic haematuria. Risk factors for bladder cancer should be assessed before initiating pioglitazone treatment.

The EMA agreed that there is a need for further analysis of the types, evolution and severity of bladder cancer in patients treated with pioglitazone compared to diabetics not treated with pioglitazone. “It remains unclear as to whether it is an early effect or a risk with prolonged use/high cumulative dose,” therefore, they requested that the manufacturer, Takeda Pharmaceuticals, conduct a pan-European epidemiological study focusing on “more robust characterization of the risk, in particular the risk period and risk with increasing age, to inform the evidence-base for risk minimization measures.”

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Questions and Answers on the Review of Pioglitazone-Containing Medicines