FDA cautions about bladder cancer increase with long-term Actos use

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The FDA has begun a safety review of the diabetes drug Actos (pioglitazone, Takeda), after receiving preliminary results from a long-term observational study designed to evaluate the risk of bladder cancer associated with use of this drug.

The preliminary results are based on five-year data from an ongoing, 10-year observational study by Takeda Pharmaceuticals North America in San Diego. The agency added that these early results showed “no overall association between Actos exposure and risk of bladder cancer. However, there was an increased risk of bladder cancer in patients with the longest exposure to Actos and in those with the highest cumulative dose of the drug.”

At this time, the FDA said its review is ongoing, and it has not concluded that Actos increases the risk of bladder cancer.

Actos is used to control blood sugar in patients with type 2 diabetes mellitus. It is in the class of drugs known as peroxisome proliferator-activated receptor (PPAR) agonists. The only other drug in this class is Avandia (rosiglitazone, GlaxoSmithKline), which has received regulatory scrutiny this summer due to its potential to increase the risk of MI. The FDA has no clinical information associating Avandia with bladder cancer in patients receiving that drug.

Bladder cancer is estimated to occur in 20 per 100,000 persons annually in the U.S. and is thought to be higher in diabetics.