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Actos Warning Upgraded on Drug Product Label Concerning Bladder Cancer

Posted on November 14, 2011

Public Citizen, in its Worst Pills, Best Pills publication, reports that on August 4, 2011, the U.S. Food and Drug Administration (FDA) revised the warning on the type 2 diabetes drug, Actos, to include a warning about an increased risk of Actos bladder cancer. Actos, made by Takeda Pharmaceuticals, is also known as pioglitazone. It is available as a standalone drug, or can be combined with the diabetes drug metformin or with glimepiride.

It wasn’t that long ago that another drug in the same family, Rezulin, was taken off the market because of living toxicity. Actos is also part of the same family, which also includes Avandia, and it can carry an elevated risk of heart attack and failure, as well as eye abnormalities and bone fractures. Even before the bladder cancer risk was known, the advocacy group Public Citizen had put Actos on its ”Do Not Use” list because the risks seemed to outweigh the benefits, especially considering there are longer term and safer drugs available such as metformin (Glucophage).

A ten-year study on pioglitazone is underway and is being conducted by the Kaiser Permanente Northern California health plan. Last April, half way through the study, investigators found an increased risk of bladder cancer among patients who had taken the drug the longest or who had taken the highest dosage. France has already suspended sales there as a result of the increased risk for bladder cancer, estimated by the FDA to be 27.5 cases of bladder cancer for every 100,000 patients.

Initial arguments in the defective product cases involving Actos should begin to be heard in December 2011. The pharmaceutical litigation attorneys in Florida of Farah & Farah are talking to patients who have taken or are currently taking this dangerous drug. We will offer anyone who’s been associated with this drug a complimentary consultation with an experienced product liability attorney.