Respiratory dysfunction following initiation of mirabegron: A case report

Abstract

Background: Mirabegron, a β3 adrenergic receptor agonist, is FDA approved for treatment of overactive bladder. Approved in 2012 in the US, there have been no reports of any effects of mirabegron on pulmonary function. Case presentation: We report the case of a 65 year old male with a history of Parkinson's disease, OSA, and aspiration pneumonia presenting with subacute worsening dyspnea and found to have worsening restrictive ventilatory defect with a pattern consistent with neuromuscular weakness. After recalling that initiation of mirabegron correlated with onset of his worsening symptoms, the patient decided to perform a trial period off the drug. He subsequently reported prompt improvement in his respiratory symptoms, which was confirmed objectively by pulmonary function tests. In this case, mirabegron was temporally associated with subacute worsening of the patient's pulmonary restrictive physiology, with subsequent resolution after discontinuation of the medication. Conclusions: The mechanism of this adverse effect is unknown, but we speculate that this effect may be potentially mediated by the effect of β3 adrenergic receptor agonism on skeletal muscle, in this case in a patient with pre-existing neuromuscular disease. Careful assessment of patients who develop shortness of breath while on mirabegron should include an assessment for restrictive lung disease secondary neuromuscular dysfunction. Additional study is needed of the effects of β3 agonism on skeletal muscle.

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

“…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.…”

Examining the Safety of Mirabegron: An Analysis of Real-World Pharmacovigilance Data from the US FDA Adverse Event Reporting System (FAERS) Database

“…Hence, mirabegron is being embraced and utilized more extensively in the management of OAB.Based on drug instructions and randomized controlled studies, common AEs associated with mirabegron include nausea, headache, hypertension, constipation, dizziness, tachycardia, and nasopharyngitis [7, 9, 10]. However, some new and uncommon AEs have gradually been identi ed, such as tongue angioedema, serum sickness-like reaction, and respiratory dysfunction [6,11,12]. As the use of mirabegron becomes more widespread, it is crucial to heighten awareness of its safety.…”