Takeda’s Actos Drug Suspended in France on Cancer Risk Study
Takeda Pharmaceutical Co.’s best- selling drug, Actos for diabetes, will be pulled from the French market after a study showed it carried a slightly increased risk of bladder cancer, the country’s drug regulator said.
Patients taking the treatment shouldn’t stop without consulting their physician, the regulator, known as Afssaps, said in a statement on its website. Doctors should no longer prescribe the drug, the agency said after holding a meeting today to consider the medicine’s risks and benefits.
Actos, also known as pioglitazone, had sales of 387.9 billion yen ($4.8 billion) in the last fiscal year, accounting for 27 percent of Osaka, Japan-based Takeda’s revenue. The drug was approved in Europe in 2000 as an option for patients who didn’t benefit from metformin, a standard treatment, or for those also taking metformin or insulin. About 230,000 patients in France use Actos, Afssaps said.
A study the regulator commissioned “confirms a slight increase in the risk of bladder cancer in patients treated with pioglitazone,” the agency said in today’s statement.
The European Medicines Agency, which started a review of Actos’s potential cancer risk in March, said today that it will examine the results of the French study. The agency’s Committee for Medicinal Products for Human Use will discuss Actos at its next meeting the week of June 20. The agency didn’t recommend any changes in the use of Actos while the review is pending.
Tougher Surveillance
French authorities have become tougher on drug surveillance since Mediator, a diabetes medicine sold in the country for 33 years, was blamed earlier this year for the deaths of as many as 2,000 patients. French Health Minister Xavier Bertrand has pledged to overhaul the country’s drug approval and monitoring system.
Elissa Johnsen, a spokeswoman for Takeda in Deerfield, Illinois, didn’t immediately return a telephone call seeking a comment on the decision by Afssaps.
The U.S. Food and Drug Administration has been monitoring Actos amid concern the drug may increase the risk of bladder cancer. An analysis of preliminary data from a 10-year study submitted by Takeda hasn’t been shown to increase such a risk, the FDA said in a September safety announcement. Takeda won U.S. regulatory approval for the treatment in 1999.
Actos become the market leader after a 2007 study showed a 43 percent higher chance of heart attacks from GlaxoSmithKline Plc’s Avandia. A study published last year in the American Heart Association journal, Circulation, found that Actos causes as many heart problems as Avandia.
To contact the reporter on this story: Albertina Torsoli in Paris at atorsoli@bloomberg.net
To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net
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