Mirabegron, Overactive Bladder Drug, Works But Liver And Heart Concerns Raised

04/03/2012 08:24 am ET | Updated Jun 03, 2012

WASHINGTON, April 3 (Reuters) - U.S. drugs reviewers said Astellas Pharma Inc's treatment for an overactive bladder worked, but raised concerns about liver and heart safety issues.

The U.S. 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 was also tied to a higher rate of neoplasms, or tumors; urinary tract problems; and hypersensitivity reactions, according to the FDA staff.

The staff review comes ahead of an advisory panel to the FDA's vote on whether to recommend approval of the drug on Thursday. The FDA will later make a final decision.

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