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France withdraws Takeda diabetes drug

France and Germany have suspended the use of Takeda’s diabetes drug Actos after concerns that they could increase the risk of bladder cancer

France and Germany have suspended the use of Takeda's diabetes drug Actos after concerns that the drug could increase the risk of bladder cancer.

The Agence française de sécurité sanitaire des produits de santé (Afssps) has suspended the use of Actos (pioglitazone) and Competact (pioglitazone and metformin) until a European safety review has been concluded.

Afssps took the decision after a French study of public insurance data confirmed a slight increase in the risk of bladder cancer in patients treated with pioglitazone.

It said the suspension would take effect from next month in order for patients who are currently using either of the medications to switch to new ones. It estimated 230,000 patients in France were currently using one of the medications.

A Takeda spokeswoman told the Wall Street Journal: "We're working swiftly to deal with the orders raised by the French and German drug safety authorities."

The EMA's Committee for Medicinal Products for Human Use (CHMP) started a European review of pioglitazone-containing medicines in March 2011 to investigate the signal of a possible increased risk of bladder cancer with pioglitazone.

The CHMP is currently reviewing all relevant data, including data from pharmacoepidemiological studies, non-clinical and clinical data, post-marketing reports of bladder cancer and published data to assess their impact on the balance of benefits and risks of these medicines. The committee will now also assess the results of the French study and its potential impact on the use of these medicines across the whole EU. The CHMP will discuss this issue at their next meeting on 20-23 June 2011 and recommend appropriate actions as necessary.

While this review is ongoing the CHMP is not recommending any changes to the use of pioglitazone-containing medicines.

Actos, which is typically used to treat type-2 diabetes, has annual 2010 sales of Y387.9 billion ($4.83 billion).

13th June 2011

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