Core Viewpoint - The National Medical Products Administration (NMPA) has decided to revise the labeling of Montelukast formulations, including warnings about potential neuropsychiatric adverse reactions such as depression and suicidal tendencies, which has raised concerns among parents and the public [1][2]. Group 1: Regulatory Changes - The NMPA's announcement aims to alert doctors and patients to monitor for neuropsychiatric side effects while using Montelukast, but it does not imply that the drug is unsafe or should not be used [2][3]. - The revision of the drug's labeling is intended to ensure that healthcare providers weigh the risks and benefits of the medication during treatment [2]. Group 2: Usage Guidelines - Montelukast is commonly used for treating asthma and allergic rhinitis, and its benefits may vary depending on the condition being treated [2][3]. - Patients, especially children, should be closely monitored for any changes in behavior or mood during treatment, and any concerning symptoms should be reported to a healthcare provider [3][4]. Group 3: Precautions for Specific Populations - Parents should inform doctors of any previous neuropsychiatric history before their children use Montelukast, and they should monitor their children's emotional and behavioral changes closely [4]. - Pregnant and breastfeeding women are advised to avoid Montelukast unless absolutely necessary, as safety studies in these populations are lacking [4].

Core Viewpoint - The National Medical Products Administration (NMPA) has announced a unified revision of the instructions for Montelukast formulations to enhance public medication safety based on adverse drug reaction assessments [1][2] Group 1: Regulatory Changes - The NMPA requires all marketing authorization holders of Montelukast products to revise their instructions according to the new guidelines by March 12, 2026 [1] - The revisions must include updates to drug labels and any other content that aligns with the original approval [1] - Products manufactured after the filing date cannot use the original drug instructions [1] Group 2: Compliance and Enforcement - Marketing authorization holders must conduct in-depth research on the mechanisms of newly identified adverse reactions and implement effective measures for medication safety training [1] - Provincial drug supervision departments are tasked with ensuring compliance among marketing authorization holders regarding the instruction revisions and label updates [2] - The NMPA emphasizes that patients should carefully read drug instructions before use and adhere strictly to medical advice when using prescription medications [2]