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Takeda's Actos passes European safety review

Diabetes medicine can still be used despite concerns bladder cancer risks

The European Commission (EC) has said Takeda's Actos (pioglitazone) can still be prescribed in Europe following a safety review.

But the diabetes drug, and Takeda's other pioglitazone brands, will have to have their product labelling updated as a result of being associated with a small increased potential risk of bladder cancer.

The announcement comes three months after the European Medicines Agency (EMA) recommended products containing pioglitazone remained an appropriate treatment option for diabetes, despite the safety concerns.

European regulatory advisors concluded in July 2011 that this risk could be reduced by appropriate patient selection and exclusion, updated contraindications and warnings in the product labels, and periodic review of the efficacy and safety of the patient's treatment.

They further advised in October last y ear that Actos only be used when metformin is not suitable or has failed to work adequately.

A review of the drug, which is known outside the US, UK, Canada and Germany as Glustin, was initiated out by the EMA's Committee for Medical Products for Human Use (CHMP) in March 2011 after fears were raised over the its role in causing bladder cancer.

France and Germany both suspended use of the drug in June 2011 until conclusion of the review.

Takeda said it 'continues to remain confident in the therapeutic benefits of pioglitazone as an important treatment for type 2 diabetes' despite the drug's risks and increasingly limited market potential.

11th January 2012

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