Huang Hesen, Chen Kaiqin, Du Yu, Gao Jing, Ye Yixian, Lin Wei
Department of Otolaryngology-Head and Neck Surgery, Xiang'an Hospital of Xiamen University, Xia Men, Fu Jian, 361102, China.
Department of Neurosurgery, Xiang'an Hospital of Xiamen University, Xia Men, Fu Jian, 361100, China.
BMC Pharmacol Toxicol. 2025 Jul 1;26(1):130. doi: 10.1186/s40360-025-00959-3.
Montelukast(MTK) is a leukotriene receptor antagonist widely used clinically for treating asthma and rhinitis. However, many adverse events (AEs) have been reported. In this study, we aimed to investigate MTK's adverse drug reactions (ADRs) using real data from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database.
We assessed the disproportionality of MTK-associated AEs by calculating metrics such as the ratio of reported ratios (ROR), proportional reporting ratios (PRR), Bayesian Belief Propagation Neural Networks (BCPNN), and Gamma-Poisson Shrinkers (GPS).
From 2004 to the third quarter of 2023, of the 20,340,254 case reports in the FAERS database, 86,732 MTK reports were recorded as "principal suspect (PS)" AEs.Disproportionate analyses identified 431 preferred terms (PTs) associated with MTK in 27 organ systems. Unexpected major AEs were noted, such as Suffocation feeling, Adrenal suppression, Sudden visual loss and Endocardial fibrosis, none of which were mentioned in the drug insert.
Our findings are consistent with clinical observations highlighting potential new and unexpected ADR signals associated with MTK. Further prospective clinical studies are needed to confirm and elucidate the relationship between MTK and these ADRs. This study provides a fresh and unique perspective on the study of adverse drug events.
孟鲁司特（MTK）是一种白三烯受体拮抗剂，在临床上广泛用于治疗哮喘和鼻炎。然而，已有许多不良事件（AE）的报道。在本研究中，我们旨在利用美国食品药品监督管理局不良事件报告系统（FAERS）数据库中的真实数据，调查MTK的药物不良反应（ADR）。
我们通过计算报告比值比（ROR）、比例报告比值（PRR）、贝叶斯信念传播神经网络（BCPNN）和伽马-泊松收缩法（GPS）等指标，评估与MTK相关的AE的不成比例性。
从2004年到2023年第三季度，在FAERS数据库的20340254例病例报告中，有86732份MTK报告被记录为“主要怀疑（PS）”AE。不成比例分析确定了27个器官系统中与MTK相关的431个首选术语（PT）。注意到了意外的主要AE，如窒息感、肾上腺抑制、突然视力丧失和心内膜纤维化，这些在药品说明书中均未提及。
我们的研究结果与临床观察一致，突出了与MTK相关的潜在新的和意外的ADR信号。需要进一步的前瞻性临床研究来确认和阐明MTK与这些ADR之间的关系。本研究为药物不良事件的研究提供了一个全新的独特视角。
