France pulls Takeda diabetes drugs after cancer fears
pharmafile | June 13, 2011 | News story | Sales and Marketing | Actos, Competact, EMA, Takeda
The French medicines agency has moved to prevent two Takeda diabetes drugs from being prescribed after fears they 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.
A Takeda spokeswoman told the Wall Street Journal that German authorities had taken a similar decision, and it would work with both countries to deal with their safety worries.
The drugs have not been withdrawn from the market, but regulators in Europe and the US have concerns over their use.
In September last year the FDA said it was looking at data from an ongoing follow-up study designed to evaluate whether Actos is linked to an increase in cancer risk.
The EMA took a similar decision in March this year and launched a formal probe of the possible link after it saw an increase in reports of cancer in patients taking pioglitazone-containing drugs across Europe.
The EU regulator’s drug safety arm the CHMP is now reviewing all relevant data, including data from pharmacoepidemiological studies, non-clinical and clinical data, post-marketing reports of bladder cancer and published data, in order to assess their impact on the balance of benefits and risks of these medicines.
The Committee said it would now also assess the results of the French study and its potential impact on the use of these medicines across the whole EU, and is set to discuss the issues at hand during their next meeting on the 20-23 June.
Until then, the CHMP is not recommending any changes to the use of pioglitazone-containing medicines.
This will be a blow to Takeda and could greatly damage the future potential of Actos, which with annual 2010 sales of Y387.9 billion ($4.83 billion), is its leading product.
Ben Adams
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