In June 2011, the FDA announced it was changing the Actos warning label to include information about the potential increased risk of bladder cancer in patients who used Actos for more than one year. Specifically, the FDA noted that although a study showed no overall increased risk of bladder cancer associated with pioglitazone (the generic name for Actos), there was an increased risk of bladder cancer in patients who had the highest cumulative dose of pioglitazone and in those with the longest exposure to the medication.
The FDA's review of Actos was announced in September 2010, and involved data from a 10-year epidemiological study that was designed to determine whether the use of pioglitazone was linked to an increased risk of bladder cancer.
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"In preclinical carcinogenicity studies of pioglitazone, bladder tumors were observed in male rats receiving doses of pioglitazone that produced blood drug levels equivalent to those resulting from a clinical dose," the FDA stated.
Furthermore, a study in France suggested an increased risk of bladder cancer linked to the use of pioglitazone.
According to reports (CBC; 08/05/11), lawsuits have been filed against Takeda Pharmaceuticals Co. Ltd., alleging patients developed bladder cancer after using Actos. Lawsuits allege the company did not adequately warn patients about the risks associated with the use of Actos. Some lawyers report they have more than 100 cases already evaluated and more pending against Takeda.