FDA Revises Warning Label for Myrbetriq

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FDA Revises Warning Label for Myrbetriq
FDA Revises Warning Label for Myrbetriq

FDA Revises Warning Label for Myrbetriq
FDA Revises Warning Label for Myrbetriq

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

The revised label includes information about angioedema, a type of swelling that may be caused by an allergic reaction, of the face, lips, tongue and/or larynx. The FDA website states that angioedema has been reported 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.

The FDA approved Myrebetriq to treat an overactive bladder in 2012. The drug is approved to treat adults with symptoms of urgency, frequency and leakage. Myrebetriq works by targeting the smooth muscle surrounding the bladder, increasing its capacity to store urine. 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.