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Actos to be Withdrawn in France

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French medicine regulators have banned diabetes drug Actos from their market citing study results which link the drug to an increased risk of bladder cancer. The French Health Products Safety Agency (AFSSAPS) announced Takeda’s drugs Actos and Compectact will be withdrawn in the country based on a French study showing an adjusted hazard ratio for bladder cancer among those taking the drug, reported InPharm.com.

The study was conducted by the nation’s insurance company and compared 155,000 patients in France taking pioglitazone, the generic version of Actos, from 2006 to 2009 to 1.3 million diabetics not using the drug. Researchers found a dose effect among those receiving a cumulative dosage of 28,000 mg or more resulting in an increased risk of bladder cancer.

In June, German and French drug regulators suspended the sale of Actos following release of the study.

Actos was approved in 1999 to lower glycemic levels in adults with Type-2 diabetes, which is caused when the body no longer responds to insulin resulting in overeating and lack of exercise. The drug is currently Takeda’s best-selling product generating $4.83 billion in 2010, says InPharm.

The European Medicines Agency will issue a safety announcement regarding the drugs at their meeting later this month. The agency’s Committee for Medicinal Products for Human Use is currently reviewing clinical and non-clinical data from pharmacoepidemiological studies to determine the benefits and risks of pioglitazone-containing drugs.

On June 15, the U.S. Food and Drug Administration released a safety announcement saying patients taking Actos may be at risk of developing bladder cancer. The agency said those taking Actos for more than one year or patients with exposure to the highest cumulative dose of the drug are at risk. The agency based its warning on an interim review of an on-going, ten-year epidemiological study.

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