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New Analysis Supports Link Between Actos and Bladder Cancer

According to, recent analysis of the safety profile of pioglitazone (Actos) shows an association between Actos and the risk of bladder cancer. The study published in Diabetes Care, was conducted by Dr. Caro Piccinnii and colleagues from Bologna, Italy.

The researchers used data from the FDA Adverse Event Reporting System (AERS) and found that 93 cases of bladder cancer were reported between 2004 and 2009 in patients using drugs to treat their diabetes. Of these 93 reports, 31 patients had been treated with Actos prior to developing bladder cancer. Using these figures, the researchers found an ROR (adverse-drug-reaction odds ratio) of 4.30. According to the analysis, this is a significantly increased risk of bladder cancers compared to other diabetes treatments.

Actos is currently under a safety review by the FDA. The FDA announced in September 2010, that it would be reviewing the safety of Actos based on preliminary studies that suggest an increased risk of bladder cancer in users of the drug.

Categories: FDA, Actos, bladder cancer

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