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, highlighting potential neuropsychiatric adverse reactions associated with the drug [3][9]. Group 1: Drug Safety and Revisions - The revised instructions will include warnings about neuropsychiatric adverse reactions reported across all age groups, including severe reactions such as depression and suicidal tendencies [3][4]. - Patients experiencing neuropsychiatric symptoms during Montelukast treatment are advised to discontinue use and seek medical attention [3][4]. Group 2: Market and Usage Insights - Montelukast is a common asthma treatment drug, initially developed by Merck and approved for sale in foreign markets in 1998. Following the expiration of its patent in China, several generic versions have been approved [8]. - In 2023, Montelukast's sales in Chinese public medical institutions exceeded 1 billion yuan, ranking among the top five obstructive airway disease medications [8]. - The drug is frequently used in children due to concerns about the side effects of inhaled corticosteroids, although it can cause side effects such as drowsiness and potential depressive tendencies [8]. Group 3: Regulatory and Clinical Implications - The NMPA's requirement for the revision aligns with previous warnings issued by the U.S. FDA regarding the drug, indicating a proactive approach to drug safety [9]. - The drug's marketing authorization holders are expected to conduct in-depth research on the mechanisms of newly identified adverse reactions and implement effective measures for safety training and communication [9].