Understanding the Black Box Warning of Montelukast

Montelukast, a leukotriene receptor antagonist, is commonly used in the management of asthma and allergic rhinitis. However, concerns regarding its neuropsychiatric side effects have led to a black box warning by the FDA. This review discusses the black box warning, examines relevant studies from India, and considers alternative treatments. BLACK BOX WARNING OF MONTELUKAST The U.S. Food and Drug Administration (FDA) added a black box warning to montelukast in 2020 due to reports of serious neuropsychiatric events, including agitation, depression, suicidal thoughts, and behavior.[1] This decision was based on accumulating evidence from post-marketing surveillance and clinical studies, indicating that these adverse effects, although rare, were significant enough to warrant the highest level of caution.[2] Several studies have contributed to understanding the safety profile of montelukast. Paljarvi T et al. study found that patients with asthma or allergic rhinitis had increased odds of adverse neuropsychiatric outcomes after montelukast initiation. Their findings suggest that clinicians should consider monitoring potential adverse mental health symptoms during montelukast treatment, particularly in individuals with a history of mental health or sleep problems.[3] According to the study by Atlas U et al., study’ at least one neuropsychiatric finding developed in approximately 1 in 5 children. Identifying risk factors will enable more careful treatment or consideration of alternative treatments for children at higher risk.[4] ALTERNATIVE TREATMENTS Given the potential risks associated with montelukast, alternative treatments for asthma and allergic rhinitis should be considered. Inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA) remain the mainstay of asthma treatment, providing effective symptom control with a well-established safety profile.[5] For allergic rhinitis, intranasal corticosteroids and antihistamines are commonly used and have been shown to be effective with minimal side effects.[5] While montelukast remains a valuable option for many patients, the black box warning underscores the importance of awareness and monitoring of neuropsychiatric side effects. Clinicians should consider individual patient risk factors and explore alternative treatments when appropriate to ensure optimal safety and efficacy in managing asthma and allergic rhinitis. Author’s contribution Dr. Suresh Dange – Literature Review Dr. Mayur Ingale - Manuscript guidance Dr. Jinitha Panikar – Manuscript draft Dr. Rose Johnson – Proof reading and Corresponding. Data availability statement The data that support the findings of this study are available on request from corresponding author. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.