Actos Officially Withdrawn in France amid Bladder Cancer Woes

More trouble for <"http://www.yourlawyer.com/topics/overview/actos">Actos (piolglitazone) today, as media outlets are reporting that Takeda Pharmaceuticals is officially withdrawing the diabetes drug from the market in France. Last month, French regulators announced that sales of Actos were being suspended there, after a study indicated that patients taking the drug were at a higher risk of bladder cancer.

The French Actos suspension meant that prescriptions for the drug could no longer be written, but people who were already taking the drug were able to continue. But according to a report from InPharm.com, the Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS) apparently thought stronger action was needed, and has asked Takeda to remove Actos from the market entirely, along with another drug called Competact (piolglitazone and metformin). In a statement, Takeda said it was working with French regulatory authorities to implement the Actos withdrawal.

Takeda’s Actos troubles began last month, after a study commissioned by the French government indicted that Actos patients face a higher risk of developing bladder cancer compared to those treated with other diabetes medication. That study examined cancer rates in some 155,000 people taking Actos in France from 2006 to 2009 and 1.3 million other diabetics who were not receiving the drug. The study found about a 22 percent higher risk of bladder cancer in those taking Actos compared with diabetics taking other drugs. The bladder cancer risk was highest in those receiving a cumulative Actos dosage of 28,000 mg or more during the study period.

Last year, the U.S. Food & Drug Administration (FDA) began its own Actos safety review after an analysis of a decade-long study found an increased risk of bladder cancer among patients with the longest exposure to Actos, as well as in those exposed to the highest cumulative dose of Actos. Overall, however, the study did not show a statistically significant association between Actos exposure and bladder cancer risk.

Following the release of the recent French Actos study, the FDA said in a Drug Safety Alert that information regarding the possible association between Actos and bladder cancer would be added to the “Warnings and Precautions” section of the drug’s U.S. label. The FDA also said its review of Actos in regards to bladder cancer is ongoing, and it will update the public when more information becomes available. In the meantime, the agency has cautioned doctors not to prescribe Actos to people with active bladder cancer, and to use the drug with caution in patients who have a history of the disease. The benefits of blood sugar control with Actos should be weighed against the unknown risks for cancer recurrence, the FDA said.

The French Actos study also prompted Germany’s drug regulator to suspend sales of the medication in that country. The European Medicine Agency’s Committee for Medicinal Products for Human Use will take up the issue of bladder cancer and Actos at meeting later this month.

This entry was posted in Actos, Pharmaceuticals. Bookmark the permalink.


© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.