August 15, 2012 — A new study published in the Journal of the National Cancer Institute has linked Actos (pioglitazone), a popular diabetes medication, to an increased risk of bladder cancer. Researchers from the University of Pennsylvania’s Perelman School of Medicine found that people taking any drug in the thiazolidinedione (TZD) class of diabetes drugs (including Actos and Avandia) were 2-3 times more likely to develop bladder cancer compared to people taking a diabetes drug in the sulfonylurea class (including Glucotrol).
The researchers analyzed records from the U.K. Health Improvement Network database, which included data on 60,000 people with type-2 diabetes.
People who have diabetes are already at an increased risk for bladder cancer compared to the general population. Finding that a diabetes medication further increases this risk is important information when considering treatment. In the general population, about 30 per 100,000 people get bladder cancer. Among diabetics, 40 per 100,000 get bladder cancer. About 60 per 100,000 taking a sulfonylurea drug are expected to get bladder cancer. However, for patients taking a TZD (such as Actos), the risk is about 170 people per 100,000.
Because tens of millions of people have type-2 diabetes in the United States, even a small increased risk of bladder cancer could translate to thousands of excess cases of the disease.
The findings of the study are most relevant for Actos. Most diabetics in the United States stopped taking Avandia after it was linked to severe cardiovascular problems. However, Actos remains a popular diabetes drug, with 15 million prescriptions written every year. It is often used when Metformin fails to adequately control a diabetic’s blood-sugar levels.
The U.S. Food and Drug Administration (FDA) has already published warnings about the risk of Actos bladder cancer. In June 2011, the agency warned that a study linked Actos to a 40% increased risk of bladder cancer when it is taken for more than one year. The Warnings and Precautions on the label was updated with the risk information.
Health authorities in Germany and France have also taken steps to restrict sales of Actos within their countries. Their actions were prompted when French researchers found a link between Actos and bladder cancer. That study involved 1.5 million patients with diabetes who were tracked for four years. The study found that bladder cancer risk was increased for patients who took high doses of Actos for at least one year.
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