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FDA Reviewing Potential Risk of Bladder Cancer with Diabetes Drug Actos

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September 17, 2010

The U.S. Food and Drug Administration (FDA) announced today that the agency is reviewing data from an ongoing 10-year study to evaluate whether Actos (pioglitazone) is associated with an increased risk of bladder cancer.

Actos, made by the pharmaceutical company Takeda Pharmaceuticals North America Inc., is a prescription medication prescribed to control blood sugar in adults with type 2 diabetes mellitus. It is in the class of drugs known as peroxisome proliferator-activated receptor (PPAR) agonists which also includes the diabetes drug Avandia (rosiglitazone). Avandia is under FDA review for potential cardiac side effects such as heart attack or stroke.

“Overall, there was no statistically significant association between Actos exposure and bladder cancer risk,” the FDA said in the announcement. “However, the risk of bladder cancer increased with increasing dose and duration of Actos use, reaching statistical significance after 24 months of exposure.”

The FDA cautioned that the agency has not concluded that Actos increases the risk of bladder cancer, as the review is ongoing and expected to take several months.

The FDA advises that patients should continue taking Actos unless directed by their physician otherwise and to discuss concerns with their doctor.

Patients should also Report adverse events involving Actos to the FDA MedWatch program.