Actos May Pose Bladder Cancer Danger

<"">Actos is being investigated by the US Food & Drug Administration (FDA) for a possible link to bladder cancer. In September, the agency issued an alert saying it was looking into a possible Actos-bladder cancer connection after preliminary data from an ongoing, ten-year epidemiological study suggested that bladder cancer is a potential Actos safety risk that needs further study.

Actos is used along with diet and exercise to control blood sugar or improve control of blood sugar in adults with type 2 diabetes mellitus. The label for Actos already contains information about bladder cancer risk in the “Precautions – Carcinogenesis, Mutagenesis, Impairment of Fertility” section. Studies in animals prior to the marketing of Actos showed an increase in bladder tumors in male rats exposed to the levels used in humans, as did a liver safety study in humans.

The study that prompted the FDA review is being conducted by Takeda, the manufacturer of Actos. It involves 193,000 patients with diabetes who are members of the Kaiser Permanente Northern California health plan. At the five-year mark,data collected between January 1, 1997 and April 20, 2008 did not show a statistically significant association between exposure to Actos and an increased risk of bladder cancer. However, the FDA said the risk of bladder cancer increased with increasing dosages of the drug and with increasing duration of use and became statistically significant after 24 months.

At the time it issued the alert, the FDA said it was continuing to review the data from the study, and would update the public in several months. It has not yet concluded that Actos increases the risk of bladder cancer.

While the FDA continues its Actos review, healthcare professionals have been advised to continue to follow the recommendations in the drug label when prescribing Actos. Patients should continue taking Actos unless told otherwise by their healthcare professional, the agency said. Those with concerns about Actos and bladder cancer should speak with their doctor.

Bladder cancer is estimated to occur in 20 per 100,000 persons per year in the US, according to the FDA. The rate of occurrence is thought to be higher in diabetics.

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