Mirabegron Associated Angioedema: A Case Report

Abstract

Purpose: To review a case of angioedema associated with mirabegron. Summary: A 77-year-old woman presented to the emergency department with swelling of the left anterior side of the tongue beginning 90 minutes prior to arrival. She noticed tingling on her tongue while eating a hamburger, chips, and ice cream. The patient had no history of medication-related allergies. Home medications include acetaminophen, aspirin, biotin, black cohosh, Co-enzyme Q-10, cranberry, fish oil, multivitamin, alendronate, and mirabegron all taken orally. The patient reports being on mirabegron for 3 to 4 years but recently decided to self-taper off the medication. Her initial laboratory test results were unremarkable. The patient was diagnosed with left tongue angioedema, and she received methylprednisolone, epinephrine, famotidine, and 2 units of plasma. After medication administration, the patient underwent a flexible nasopharyngeal laryngoscopy resulting in no significant angioedema in the pharynx and hypopharynx with a small area of possible edema noted on the right base of tongue/lingual tonsil. Patient’s symptoms improved with medication treatment and discontinuation of mirabegron. The use of Naranjo et al. adverse-event probability scale revealed that mirabegron was the possible (score of 4) cause of the patient’s left tongue angioedema. Conclusion: A 77-year-old woman developed drug induced tongue angioedema associated with mirabegron after being compliant on this medication for 3 to 4 years. Patient was self-tapering her dose of mirabegron. This patient responded well to medication treatment and discontinuation of drug. To our knowledge, this is the second case report of mirabegron induced angioedema.

Examining the safety of mirabegron: an analysis of real-world pharmacovigilance data from the US FDA adverse event reporting system (FAERS) database

“…Some other new and unexpected adverse events, including lip swelling, swollen tongue, mouth swelling, peptic ulcer, ischemic colitis, eyelid edema, glaucoma, and retinal vein occlusion, were also identified in this study. Matthew et al ( Zuchowski et al, 2022 ) reported a case of a patient who experienced tongue swelling, accompanied by difficulty breathing and swallowing, after using mirabegron. In this report, swelling was also observed in areas such as the lips, oral cavity, and eyelids.…”

“…In this report, swelling was also observed in areas such as the lips, oral cavity, and eyelids. The mechanism of mirabegron-induced edema is believed to be a type I hypersensitivity reaction mediated by mast cell degranulation ( Zuchowski et al, 2022 ).…”

“…In 2012, mirabegron, a β-3 adrenergic receptor agonist, gained approval from the Food and Drug Administration (FDA) for treating OAB, inducing detrusor smooth muscle relaxation during the storage phase and increasing bladder capacity ( Zuchowski et al, 2022 ; Kuo and Kuo, 2023 ). According to a Phase III, randomized, multicenter study ( Herschorn et al, 2013 ), mirabegron is an effective treatment option for OAB, with a low incidence of adverse events (AEs).…”

“…Based on drug instructions and randomized controlled studies, common AEs associated with mirabegron include nausea, headache, hypertension, constipation, dizziness, tachycardia, and nasopharyngitis ( Nitti et al, 2013a ; Herschorn et al, 2013 ; Yamaguchi et al, 2015 ). However, some new and uncommon AEs have gradually been identified, such as tongue angioedema, serum sickness-like reaction, and respiratory dysfunction ( Malsin et al, 2019 ; Tan et al, 2019 ; Zuchowski et al, 2022 ). As the use of mirabegron becomes more widespread, it is crucial to heighten awareness of its safety.…”