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Another Study Finds Link Between Actos and Bladder Cancer

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Philadelphia, PAAnother study has been released suggesting a link between Actos and bladder cancer. The study, conducted by researchers at the University of Pennsylvania, adds to the literature on serious Actos side effects. Meanwhile, Actos bladder cancer lawsuits have been filed, alleging patients were harmed by use of the diabetes medication.

The study was published online in the Journal of the National Cancer Institute (8/9/12) and found that patients who took TZD (thiazolidinedione drugs, which include Actos and Avandia) for more than five years had two to three times the incidence of bladder cancer as patients taking sulfonyurea (also diabetes medications) drugs. The study found that the risk of bladder cancer increased as time from the initiation of medication increased. Researchers noted that there did not seem to be a difference in the rate of cancer between patients who used Actos and those who used Avandia.

"Long-term TZD therapy in patients [more than five years] with type 2 diabetes may be associated with an increased risk of bladder cancer, which may be common to all TZDs," researchers concluded.

On June 15, 2011, the FDA announced that taking Actos for more than one year could be associated with an increased risk of bladder cancer. At the time of the announcement, the FDA said information about that risk would be included on the Actos medication guide. The announcement was made after an interim analysis of a ten-year epidemiological study showed an increased risk of bladder cancer in patients with the longest exposure to pioglitazone (the generic version of Actos) and those with the highest cumulative dose.

The FDA further noted that a study conducted in France also suggested an increased risk of bladder cancer in patients who used pioglitazone. Although the FDA did not recommend removing Actos from the market, it did recommend the drug not be used in patients with active bladder cancer or with a history of bladder cancer. The agency said it would continue to evaluate data from the study.

Lawsuits have been filed by patients who allege they developed bladder cancer after using Actos. They claim Takeda Pharmaceuticals, maker of Actos, did not adequately warn patients about the risks associated with the medication.

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