Although France and Germany suspended use of the Actos diabetes pill, the European Medicines Agency has decided to take a more conservative approach and today recommended that Takeda Pharmaceuticals simply place new warnings about possible links to bladder cancer.
In reaching its decision, the EMA's Committee for Medicinal Products for Human Use, or CHMP, decided that there are some patients who cannot be adequately treated by other drugs and who will benefit from continued treatment with Actos. "The CHMP agreed that it was not possible to further restrict the current indications of pioglitazone," according to the EMA statement.
Last week, the Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS) asked Takeda to withdraw Actos and based its decision by AFSSAPS on a study by a national French insurer that examined nearly 1.5 million people between 40 and 79 years old who were treated between 2006 and 2009 (read here and here).
In a statement, Takeda says that, "if the EMA’s opinion is adopted by the European Commission, Takeda will work with the EMA to implement the decision across Member States, and will update physician and patient information to reflect these changes."
The FDA, meanwhile, continues to review the diabetes drug for bladder cancer risks. Last year, the agency disclosed a review of data from an ongoing, 10-year epidemiological study designed to evaluate whether Actos is associated with an increased risk of bladder cancer. Findings from studies in animals and humans suggest this is a potential safety risk that needs further study. But the FDA had not concluded that Actos increases the risk of bladder cancer (read this).