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FDA announces preliminary safety review of pioglitazone
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The FDA is evaluating preliminary results from a long-term, observational study suggesting patients assigned pioglitazone may be at increased risk for bladder cancer. As of press time, the FDA’s review is ongoing and they have not confirmed an association between pioglitazone and bladder cancer risk.
According to the FDA, the preliminary data are based on 5-year results from an ongoing, 10-year study conducted by Takeda Pharmaceuticals. Although preliminary findings indicated no association between exposure to pioglitazone (Actos, Takeda) and risk for bladder cancer, there was an increased risk among patients with the longest duration of exposure to the drug as well as in those assigned the highest cumulative dosage.
Pioglitazone is prescribed to control blood glucose in patients with type 2 diabetes. The only other drug in this class is rosiglitazone (Avandia, GSK). FDA officials have no clinical data suggesting an association between rosiglitazone and bladder cancer. However, following an FDA advisory committee meeting back in July, officials recommended restrictions be placed on the use of rosiglitazone in addition to revised labeling that includes additional warnings about cardiovascular safety.
The FDA recommends for patients to discuss any concerns with their health care professional. However, patients should not stop taking pioglitazone unless told to do so by their health care professional.
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