Mirabegron Works for Overactive Bladder, But Concerns About Liver, Heart Safety Remain
Washington, DC -- Drugs reviewers said Astellas Pharma Inc's treatment for an overactive bladder worked, but they raised concerns about liver and heart safety issues.
The Food and Drug Administration staff said the once-daily tablet, called mirabegron, worked to reduce frequent urination and the inability to control it, according to documents released online on Tuesday.
But the pill, already approved in Japan, was also tied to a higher rate of neoplasms, or tumors, urinary tract problems and hypersensitivity reactions, according to the FDA staff.
"The special safety concerns, especially the increases in blood pressure and pulse ... require additional consideration relevant to their potential negative public health effects," staff said in the documents.
The staff review comes ahead of a vote Thursday by an FDA advisory panel on whether to recommend approval of the drug. The FDA will make a final decision by June 29, taking into account the panel's recommendation.
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