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France, Germany Ban Actos for Possible Link to Bladder Cancer

Jun 10, 2011 | Parker Waichman LLP

French and German health regulators have decided to suspend sales of Actos (pioglitazone) in those countries because of a possible association with bladder cancer.  The Actos decisions came after a study commissioned by the French government that tracked diabetics from 2006 to 2009 found that Actos increased bladder cancer risks.

In France, doctors have been directed to stop prescribing Actos to patients, but said people currently using it should consult their doctors before they stopped.  In addition to Actos, the French directive applies to Competact, which combines Actos and an older drug called metformin.

Germany's Federal Institute for Drugs and Medical Devices (BfArM) followed suit shortly after receiving the Actos study from their French counterparts.

"BfArM recommends the suspension of approval of pioglitazone (Actos) until further clarification. Doctors should not put new patients on pioglitazone," the regulator said in a statement according to Reuters.

According to a Bloomberg News report, the European Medicines Agency is also reviewing the French Actos study.  That agency embarked on its own review of the Actos-bladder cancer risk this past March.   The agency is scheduled to discuss Actos at a meeting later this month.

In the U.S., the Food & Drug Administration (FDA) has been reviewing Actos for a possible link to bladder cancer since last September.  The agency has said an analysis of preliminary data from a 10-year study submitted by the drugs' manufacturer did not show a statistically significant association between Actos exposure and bladder cancer risk.  However, the FDA also said an increased risk of bladder cancer was observed among patients with the longest exposure to Actos, as well as in those exposed to the highest cumulative dose of Actos.

In May, reported that a new review of Adverse Event reports submitted to the FDA had suggested a “disproportionate risk” of bladder cancer associated with Actos compared to other diabetes drugs.  The five-year review (2004-2009) looked at half million reactions to various diabetes medications, including 138 in which people developed bladder cancer. A fifth of those occurred in Actos patients.

The U.S. label for Actos already contains information about bladder cancer risk in the “Precautions – Carcinogenesis, Mutagenesis, Impairment of Fertility” section. Studies in animals prior to the marketing of Actos showed an increase in bladder tumors in male rats exposed to the levels used in humans.

So far, the FDA has not commented on the study that prompted the French and German Actos bans.

Bladder cancer is estimated to occur in 20 per 100,000 persons per year in the US, according to the FDA. The rate of occurrence is thought to be higher in diabetics.

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