FDA Warns Long-Term Actos Use May Raise Bladder Cancer Risk

The U.S. Food & Drug Administration (FDA) issued a Drug Safety Communication yesterday warning that people taking <"http://www.yourlawyer.com/topics/overview/actos">Actos (pioglitazone) for more than a year may face an increased risk of bladder cancer. The agency said the information on the possible association between Actos and bladder cancer will be added to the “Warnings and Precautions” section of the drug’s label.

Actos is used along with diet and exercise to improve control of blood sugar in adults with type 2 diabetes mellitus. Pioglitazone is also sold in combination with metformin (Actoplus Met, Actoplus Met XR) and glimepiride (Duetact). According to the FDA, approximately 2.3 million patients filled a prescription for a pioglitazone-containing product from outpatient retail pharmacies From January 2010 through October 2010.

According the FDA, the new Actos warning is based on its review of data from a planned five-year interim analysis of an ongoing, ten-year epidemiological study that noted an increase risk of bladder cancer among patients with the longest exposure to Actos, and in those exposed to the highest cumulative dose. The FDA first informed the public of this finding in September 2010, when it began a safety review of Actos.

The FDA also said it has become aware of a recent epidemiological study conducted in France which suggests an increased risk of bladder cancer with Actos. As we’ve reported previously, that study examined cancer rates in some 155,000 people taking Actos in France from 2006 to 2009 and 1.3 million other diabetics who were not receiving the drug. The study found about a 22 percent higher risk of bladder cancer in those taking Actos compared with diabetics taking other drugs. The bladder cancer risk was highest in those receiving a cumulative Actos dosage of 28,000 mg or more during the study period.

Last week, the findings of the French Actos study prompted regulators in France and Germany to suspend sales of the drug in those countries. Regulators in the U.K. were scheduled to take up the Actos bladder cancer issue during a meeting Thursday, and the European regulator, the Committee for Medicinal Products for Human Use (CHMP), will take up the issue on June 20.

In the U.S., the FDA will continue to evaluate data from the ongoing ten-year epidemiological study, and will also conduct a comprehensive review of the results from the French study. The FDA said it will update the public when more information becomes available.

The FDA has warned doctors not to prescribe Actos to people with active bladder cancer, and to use the drug with caution in patients who have a history of the disease. The benefits of blood sugar control with Actos should be weighed against the unknown risks for cancer recurrence, the FDA said.

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