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Mirabegron Works for Overactive Bladder, But Concerns About Liver, Heart Safety Remain
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.
Read the full article on Reuters.