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Another Study Finds Actos Increases Bladder Cancer Risks

Jun 1, 2012 | Parker Waichman LLP

More bad news today for patients taking Actos (pioglitazone), as another study has found a link between the type 2 diabetes drug and bladder cancer.  The research, published in the British Medical Journal, found that patients taking Actos are more than 80 percent more likely to develop bladder cancer than people who don’t.  For patients who had taken Actos for two years or longer, the relative risk of bladder cancer grew to 88 percent.

The study, conducted by Canadian researchers, looked at the records of more than 115,000 British patients newly treated with diabetes drugs between 1988 and 2009.  According to Reuters, the study found that Actos use of two years or more was associated with 88 extra cases of bladder cancer per 100,000 person years. This rose to 137 extra cases among patients who had taken more than 28,000 milligrams of the drug.

"Prescribers who are ultimately responsible for therapeutic choices can legitimately question whether the benefit-risk ratio of pioglitazone is still acceptable for their patients with diabetes," the authors of the report wrote in an editorial, also published in the British Medical Journal. 
Last June, the U.S. Food & Drug Administration (FDA) issued a safety communication stating that use of Actos for more than one year may be associated with an increased risk of bladder cancer. Bladder cancer concerns also caused regulators in France and Germany to suspend sales of Actos in those countries over the summer. Takeda Pharmacueticals officially recalled Actos from the French market in July.

According to Reuters, Takeda‘s revenues have dropped from their peak of $5 billion in 2010, partly due to safety concerns.  The company has also been hit with personal injury lawsuits by people who allege they developed bladder cancer because of Actos.  Some legal experts expect 10,000 such lawsuits could eventually be filed in the U.S.

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