FDA Says Astellas' Bladder Drug Poses Heart, Liver Risks

Law360, New York (April 3, 2012, 5:55 PM EDT) -- An Astellas Pharma US Inc. bladder-control drug poses risks related to high blood pressure, increased heart rate and liver problems, the U.S. Food and Drug Administration revealed Tuesday ahead of an advisory panel meeting on whether the drug should be approved.

The FDA's reproductive health drugs advisory committee will meet Thursday to discuss the risks and benefits of Astellas's mirabegron, which treats incontinence and other urinary problems and is already approved in Japan.

In a background document on mirabegron, the FDA identified “key safety issues” surrounding...
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