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Actos Label Now Carries Bladder Cancer Warning

Aug 11, 2011 | Parker Waichman LLP

A new safety label has been unveiled for Actos (pioglitazone), warning that the type 2 diabetes drug could be associated with an increased risk of bladder cancer.  The new  bladder cancer information has also been added to the labels of Actoplus Met (pioglitazone/metformin), Actoplus Met XR (pioglitazone/metformin extended release), and Duetact (pioglitazone/glimepiride).

 Recently, several studies have linked Actos to a higher risk of bladder cancer.  In June France and German suspended Actos sales after a study of more than 1 million diabetics commissioned by the French government found that Actos patients faced nearly a 22 percent higher risk of bladder cancer compared to those 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.

 The U.S. Food & Drug Administration (FDA) announced the new Actos label just days after France and Germany suspended its sales.  The new U.S. label is based on an interim data from a review of 193,099 diabetics  revealed that those taking the drug for more than a year had a 40 percent increased risk for bladder cancer.  The 10 year study will be completed in 2012. 

 The new bladder cancer information will be listed in the "Warnings and Precautions" section of the Actos label.  It advises that health care professionals avoid using Actos in patients with active bladder cancer and recommends caution in patients with a prior history of bladder cancer. Actos patients are encouraged to contact their health care provider if they notice any sign of blood in the urine, any new or worsening urinary urgency or pain during urination.

The FDA plans to conduct a comprehensive review of the results from the French study, and continue to evaluate data from the 10-year study.  The agency said it would update the public when more information becomes available.




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