FDA Updates Contraindications for Myrbetriq

FDA Updates Contraindications for Myrbetriq

The U.S. Food and Drug Administration (FDA) has updated the label on Myrebetriq to include a new contraindication and additional information in the Warnings and Precautions section. The revised label now states that the drug, which is used to treat an overactive bladder, is contraindicated in patients who are hypersensitive to mirabegron or any component of the tablet.

According to the FDA website, the label now includes information about angioedema, a type of swelling that may be caused by an allergic reaction, of the face, lips, tongue and/or larynx. There have been reports of angioedema after the first dose or after multiple doses of Myrebetriq. “Angioedema associated with upper airway swelling may be life threatening. If involvement of the tongue, hypopharynx, or larynx occurs, promptly discontinue MYRBETRIQ and initiate appropriate therapy and/or measures necessary to ensure a patent airway.” the new label reads, according to the FDA website.

Astellas Pharma gained clearance for Myrebetriq in 2012. According to the drug’s website, it is approved to treat an overactive bladder with symptoms of urgency, frequency and leakage in adults. The drug is intended to improve the bladder’s ability to store urine by relaxing the smooth muscle surrounding it. Serious side effects may include increased blood pressure, urinary retention and angioedema, according to the website. Meanwhile, the most common side effects include increased blood pressure, common cold symptoms, urinary tract infection and headache.