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Actos Recall Ordered in France

Jul 12, 2011 | Parker Waichman LLP

Actos will be officially withdrawn from the market in France, one month after officials suspended its sales there because of a study that found people taking Actos faced a greater risk of developing bladder cancer.

Two studies have recently pointed to an association between Actos and bladder cancer. The one that prompted the French Actos withdrawal was commissioned by that country's government.   It found that people taking Actos had a 22 percent higher risk of bladder cancer compared to those taking other drugs. Those taking the highest cumulative dose - 28,000 mg or more - faced the highest risk. The study followed 155,000 people taking Actos in France from 2006 to 2009 and 1.3 million other diabetics.

The study release prompted French regulators to immediately order that sales of Actos be suspended, but the drug was still available to those currently using it.  But according to a report from the French have since gone further, asking Takeda Pharmaceuticals to remove Actos from the market,  along with another drug called Competact (piolglitazone and metformin).  In a statement, Takeda said it was working with French regulatory authorities to implement the Actos withdrawal.

The same study prompted the German government to suspend sales of the drugs there, and regulators from the European Union are scheduled to discuss Actos bladder cancer association at a meeting later this month.

In the U.S., the French study caused the Food & Drug Administration (FDA) to order stronger warnings for the Actos label.   The agency is also in the midst of its own Actos bladder cancer review, after an analysis of a separate decade-long study found an increased risk of the disease among patients with the longest exposure to Actos, as well as in those exposed to the highest cumulative dose of Actos.

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