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FDA Warns Diabetes Drug Actos May Cause Bladder Cancer

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Five days after Germany and France pulled Takeda Pharmaceuticals’ diabetes drug Actos off the market, the United States Food and Drug Administration (FDA) is warning consumers that the diabetes drug (pioglitazone) may increase the risk of bladder cancer when used for more than one year. The new cancer warning will appear on Actos labeling.

Actos is in a class of drugs called thiazolidinediones, the only other member of which, Avandia (rosiglitazone), was taken off U.S. market in May because it was linked to an increased risk of heart attacks. Actos is used to control blood sugar and is sold alone or in combination with metformin (Actoplus Met, Actoplus Met XR) and glimepiride (Duetact). In 2010, more than 2 million patients were taking these drugs for Type-2 diabetes, according to the FDA.

The new warning is based on FDA’s review of data from an ongoing study which found that Actos increased the risk of bladder cancer among patients taking the drug over a long period at the highest doses. In one study involving more than 193,000 patients with diabetes, patients taking Actos were on the drug for an average of two years, the FDA said. "Compared to never being exposed to pioglitazone, a duration of pioglitazone therapy longer than 12 months was associated with a 40 percent increase in risk [for bladder cancer]," the agency said.

In addition, the agency says it is aware of the French study that caused France to pull the drug. That study showed a dose-response effect, where risks for bladder cancer rose as time spent taking Actos lengthened past one year.

Right now, the FDA is advising doctors not to use Actos in patients with bladder cancer and to use it with caution in patients who have had bladder cancer. In addition, the agency says that "the benefits of blood sugar control with pioglitazone should be weighed against the unknown risks for cancer recurrence."

The agency said diabetes patients should also tell their doctor if they are having symptoms of bladder cancer such as blood or red color in urine, an urgent need to urinate or pain while urinating and pain in back or lower abdomen.

Takeda Pharmaceuticals , a Japanese company, is sponsoring an interim study which runs through 2012, and, so far, Takeda says it remains committed to the drug. The French epidemiological study by the Caisse National d’Assurance Maladie is a retrospective study which followed diabetes patients taking antidiabetes drugs between 2006 and 2009.

U.S. sales of Actos in 2008 exceeded $2.4 billion.