August 15, 2012 — The Journal of the National Cancer Institute has published yet another study linking Actos (pioglitazone), a popular treatment for type-2 diabetes, to an increased risk of bladder cancer. The researchers found that the entire thiazolidinedione (TZD) class of diabetes drugs (which includes Actos and Avandia) was associated with a 2-3 fold increased risk of bladder cancer, when compared to diabetes drugs in the sulfonylurea class, such as Glucotrol.
The researchers were from the University of Pennsylvania’s Perelman School of Medicine analyzed medical records for 60,000 people with type-2 diabetes whose records were in the U.K.’s Health Improvement Network database.
They found that people taking a TZD (such as Actos) had the highest risk, with 170 per 100,000 developing bladder cancer. This is significantly higher than the risk for people taking a sulfonylurea (Glucotrol), which was associated with 60 cases of bladder cancer per 100,000 people. The baseline risk of bladder cancer for someone without diabetes is about 30 per 100,000, and it increases to 40 per 100,000 for people with type-2 diabetes.
Because people with type-2 diabetes already have an increased risk of bladder cancer, it is important to know when certain medications increase this risk. Furthermore, if two diabetes medications are equally effective but have different risks, most doctors will advocate the safer medication.
Globally, nearly 300 million people have type-2 diabetes, and tens of millions use a drug treatment to help control blood sugar. This means that a slight increased risk of bladder cancer could become thousands of excess cases of cancer.
The findings of the study are most significant for Actos, because it remains a popular diabetes treatment. Avandia is not prescribed very often in the United States, because researchers have associated it with an increased risk of cardiovascular problems. Actos is often the second-line treatment after Metformin fails to adequately control blood sugar levels, and 15 million prescriptions were written last year.
However, there is growing concern about the safety of Actos. In June 2011, the U.S. Food and Drug Administration (FDA) published a warning that using Actos for at least one year could increase the risk of bladder cancer by 40%. The agency has already updated the warnings and precautions on the label for Actos, but it continues to be prescribed to millions of people.
European health authorities in France and Germany have taken steps to restrict sales of Actos, but these same steps have not been taken in the United States. French researchers were some of the first to raise alarm about the risks of using Actos — in a study of 1.5 million people, they also found Actos associated with bladder cancer.
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