这款儿童常用药修订说明书：需增加抑郁、自杀倾向警告

Core Viewpoint - The National Medical Products Administration (NMPA) of China has announced a revision of the prescribing information for Montelukast formulations, mandating the inclusion of explicit warnings regarding neuropsychiatric adverse reactions, including depression and suicidal tendencies [1][2]. Group 1: Regulatory Changes - The revision is based on the results of adverse drug reaction monitoring and assessment [1]. - All Montelukast formulations, including tablets, chewable tablets, granules, and orally dissolving films, are subject to this revision, with the latter three being specifically for pediatric use [2]. - The NMPA requires all marketing authorization holders of Montelukast to revise the prescribing information by March 12, 2026, and to replace the labels of all manufactured products within nine months after the filing [3]. Group 2: Market Context - Montelukast, developed by Merck & Co., was first approved in 1998 and is a selective leukotriene receptor antagonist indicated for the prevention and long-term treatment of asthma in children aged 2 to 14 years [2]. - Following the expiration of its patent, various generic versions have emerged globally, with over 60 approved marketing numbers in China from manufacturers such as Qilu Pharmaceutical, Tianyu Pharmaceutical, and others [2]. - In 2023, Montelukast's sales in Chinese public medical institutions exceeded 1 billion yuan, ranking among the top five chemical drugs for obstructive airway diseases [2].