FDA Initiates Safety Review of Pioglitazone (Actos)
Preliminary data show bladder cancer risk up with increasing drug dose and duration of use
MONDAY, Sept. 20 (HealthDay News) -- The U.S. Food and Drug Administration has announced the start of a safety review of the type 2 diabetes drug pioglitazone (Actos), as preliminary results of a long-term observational study indicate an increased risk of bladder cancer in patients with the longest exposure to pioglitazone and the highest cumulative dose of the drug.
Pioglitazone is a peroxisome proliferator-activated receptor agonist used to control blood sugar in individuals with type 2 diabetes mellitus. The preliminary results are based on five-year data from an ongoing 10-year observational study being conducted by Takeda Pharmaceuticals North America Inc., the drug's manufacturer.
While early results showed no statistically significant overall association between pioglitazone exposure and risk of bladder cancer, the risk of bladder cancer increased with increasing dose and duration of pioglitazone use, reaching statistical significance after two years of exposure. The FDA recommends that health care professionals continue to follow the drug-label recommendations when prescribing pioglitazone.
According to a safety alert issued by the agency, "at this time, FDA has not concluded that Actos increases the risk of bladder cancer. Its review is ongoing, and the agency will update the public when it has additional information."