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In September 2010, the FDA announced it was reviewing data from an ongoing 10-year study of Actos (pioglitazone) and the risk of bladder cancer.
FDA completed its review of five-year results, which showed that although there was no overall increased risk of bladder cancer from Actos, an increased risk was found among patients who had used Actos the longest (for more than 2 years) and at the highest doses.
In June 2011, the European Medicines Agency was informed by the French Medicines Agency of its decision to suspend the use of Actos-containing medicines in France, while awaiting the outcome of the ongoing European review on the risks and benefits of some anti-diabetic medicines.
On June 15 2011 the FDA informed the public that use of Actos for more than one year may be associated with an increased risk of bladder cancer. Information about this risk would be added to the Warnings and Precautions section of the label for medicines containing Actos. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer.
In one European country (France), Actos sales are suspended until further review of the risks and benefits of this Type 2 diabetes drug. In the United States, itís business as usual and more warnings will be added to the label.
Have you or a loved one been diagnosed with bladder cancer while you were taken Actos for Type 2 diabetes? If yes, you may be eligible for an Actos bladder cancer lawsuit. How can we help you?