Takeda Pulls Actos In France Over Bladder Cancer
July 12th, 2011 // 12:51 pm @ jmpickett
Source: Pharmalot.com
One month after French regulators suspended the use of the Actos diabetes pill after a review of pharmacovigilance data showed an increased risk of bladder cancer, Takeda Pharmaceuticals has withdrawn the drug. The Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS) also asked Takeda to withdraw a related brand called Competact.
The decision by AFSSAPS was based on a study by a national French insurer and examined nearly 1.5 million people between 40 and 79 years old who were treated between 2006 and 2009 . Nonetheless, the European Medicines Agency is continuing its review, according to a statement from the drugmaker.
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.
“Takeda is confident in the therapeutic benefits of pioglitazone and its importance as a treatment for type 2 diabetes. We continuously monitor the safety and tolerability of all of our products and will continue to work with the EMA and other individual regulatory bodies to share and review all available data, and to determine appropriate next steps,†the drugmaker says in its statement.
