Astellas Overactive Bladder Drug Raises Risks, FDA Says

Astellas Pharma Inc.’s drug to treat overactive bladder has side effects including increased blood pressure that need to be considered when weighing whether the medicine should be approved, U.S. regulators said.

The medicine, mirabegron, also increased heart rate and was associated with hypersensitivity reactions ranging from painful rash to anemia, the Food and Drug Administration said today in a report ahead of an April 5 meeting of advisers on the drug.