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FDA Warns of Possible Link Between Actos Use and Bladder Cancer

Diabetes is a chronic disease characterized by the body's inability to produce and/or use insulin, resulting in high glucose levels. Because the condition can lead to many complications, medication management of the condition and its related symptoms is essential. However, recently some patients taking Takeda Pharmaceutical's Actos (pioglitazone) have learned that they may be at a higher risk for something worse: bladder cancer.

Actos is known as a thiazolidinedione antidiabetic and is widely used in treating patients with non-insulin-dependent diabetes mellitus (diabetes mellitus II.) The drug works to lower blood sugar levels by making cells more sensitive to the action of insulin. While the active ingredient, pioglitazone, may not cause cardiac issues, recent studies have shown that the drug is associated with an increased risk of bladder tumors and cancer.

In September 2010, the Food and Drug Administration (FDA), which serves as the federal watchdog for pharmaceutical safety, issued a safety announcement regarding Actos, which contained pioglitazone. The federal agency, upon a review of ten years of epidemiological data, found that lab results suggested potential safety risks. This announcement came weeks after the FDA had requested labeling changes for the drug. Just this past June, another safety announcement about new studies has prompted the FDA to caution consumers about the increased risks for those using Actos for over one year.

Takeda defends its drug by offering interim data, which did not show increased risks with short-term use or with use for more than two years. However, FDA findings indicate that long exposure and high cumulative doses create the greatest risk for bladder cancer.

While the European Medicines Agency (EMA) has yet to release guidance on the drug, two countries, France and Germany, now ban the use of Actos. The drug is the second of the thiaxzolideindione class to be linked to serious side effects in recent years. GlaxoSmithKline's Avandia, also used to treat diabetes, has been linked to increased risk for strokes and heart attacks as well.

Diabetes affects more than 25.8 million American children and adults, over 8 percent of the population. Because of this, safe and effective diabetes treatments are crucial. Actos, as a substitute for Avandia, was one of the top ten selling drugs in the United States in 2008. For some patients, safer treatment alternatives may not be available. Until there are, patients are at risk for serious conditions resulting from prescribed treatment protocols.

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