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On June 15, 2011, the FDA released a safety announcement warning the public and healthcare professionals that long-term use of the diabetes drug Actos may increase the risk of bladder cancer. The agency based their announcement on the results of an ongoing epidemiological study that found that those using Actos for over a year had a 40 percent increased risk of kidney cancer. In August 2011, new labels warning of the risk were approved for Actos.

Health Canada followed suit on April 19, 2012, warning that Actos may increase the risk of bladder cancer. Now, the Canadian agency has announced that the manufacturer, Takeda, will be updating Actos warning labels in Canada to alert diabetes patients to the Actos kidney cancer risk.

New Actos Warnings in Canada

According to Health Canada, Takeda has agreed to update Actos labels to include the following information:

  • Patients who have had bladder cancer or who have blood or red color in their urine should not use Actos.
  • Patients taking Actos should seek immediate medical attention if they notice urinary symptoms, such as red-colored urine, pain during urination, or an increased need to urinate, as these could be symptoms of bladder cancer.
  • Doctors should evaluate potential Actos patients for bladder cancer risk prior to prescribing the medication.

In addition, the province of Ontario has moved Actos off the list of drugs that may be freely prescribed to a list that requires approval before prescription.

Concerns Mounting About Actos Bladder Cancer

About the same time that the FDA issued its Actos bladder cancer warning in 2011, the French Medicines Agency issued a similar warning, based on the results of data analysis from the French National Health Insurance Plan. In July, manufacturer Takeda agreed to an Actos recall in France. Germany's Federal Institute for Drugs and Medical Devices also limited the use of Actos, advising doctors not to put any new patients on the drug until the risk of the disease could be further clarified.

Meanwhile, the number of patients filing an Actos lawsuit has steadily increased. On December 29, 2011, the U.S. Judicial Panel on Multidistrict Litigation centralized all federal lawsuits into the Western District of Louisiana for coordinated pretrial proceedings. Consolidated cases are also proceeding in California and elsewhere in state courts.

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