Product Liability

More evidence suggests Actos may cause bladder cancer

A new study is providing more evidence that the diabetes drug Actos (pioglitazone) may cause bladder cancer in patients. The drug has been under an ongoing safety review by the Food and Drug Administration (FDA) since last year when the agency received early results from a long-term study. That study, conducted by Actos maker Takeda Pharmaceuticals Co Ltd., showed a risk for bladder cancer in patients who used the drug long-term or in higher cumulative doses. The drug’s prescribing information already includes the possibility of developing bladder cancer.

The new study involved data from 2004 to 2009 of more than a half million adverse reactions associated with fifteen different medications to treat diabetes. Bladder cancer was reported in 138 cases. More than one-fifth of those reports involved Actos, which researchers say suggests a “disproportionate risk” compared to other diabetes drugs.

Drugs to treat diabetes have taken a beating in the past several months. Last year, the FDA severely restricted the diabetes drug Avandia, made by GlaxoSmithKline, after studies showed the drug may put users at greater risk for cardiovascular events. While Avandia and Actos are in the same drug class, Avandia has not been linked to bladder cancer.

The FDA says it will continue to review data from studies linking Actos to bladder cancer. Meanwhile, patients should not discontinue taking the medication without discussing the risks and benefits with their doctors. Any side effects with this or any drug should be reported to the FDA MedWatch Adverse Event Reporting Program at

Bladder cancer is the sixth most common cancer in the United States with 70,000 new cases diagnosed each year and nearly 15,000 deaths.

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ACTOS is a trademark of Takeda Pharmaceutical Company Limited registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

AVANDIA is a registered trademark of GlaxoSmithKline.

Source: Reuters