年销售超10亿元的儿童常用药，被要求增加抑郁和自杀倾向警示语

Core Viewpoint - The National Medical Products Administration (NMPA) of China has announced a unified revision of the product instructions for Montelukast formulations to enhance public medication safety, following reports of neuropsychiatric adverse reactions associated with the drug [1][2]. Group 1: Regulatory Changes - The NMPA's announcement includes a requirement for the product instructions to warn about neuropsychiatric adverse reactions reported across all age groups, including severe reactions such as depression and suicidal tendencies [1]. - The revised instructions will advise that if neuropsychiatric symptoms occur during treatment, the medication should be discontinued and medical attention sought [1][3]. Group 2: Market Context - Montelukast is a common asthma treatment drug, originally developed by Merck and approved for use in 1998. With the expiration of its patent in China, several generic versions have been approved for sale [2]. - In 2023, Montelukast's sales in Chinese public medical institutions exceeded 1 billion yuan, ranking it among the top five obstructive airway disease medications [2]. Group 3: Clinical Insights - Montelukast is primarily used as an adjunct treatment for asthma, particularly in children, who often prefer it over inhaled corticosteroids due to concerns about side effects [2]. - While some patients may experience side effects such as drowsiness or mood disturbances, most can recover after discontinuation of the drug, with few experiencing long-term effects [2].