Core Viewpoint - The National Medical Products Administration (NMPA) has announced a unified revision of the drug instructions for Montelukast sodium formulations, highlighting potential neuropsychiatric adverse reactions across all age groups, including severe symptoms like depression and suicidal tendencies, which may persist if the medication is not discontinued [1][2]. Group 1: Drug Safety and Revisions - The revised drug instructions will prominently feature a black box warning indicating that neuropsychiatric adverse reactions have been reported in patients of all ages taking Montelukast, including severe reactions such as depression and suicidal tendencies [2]. - The updated instructions will also include a new adverse reaction: stuttering, alongside other neuropsychiatric symptoms such as aggression, anxiety, and hallucinations [2][4]. - The revision aims to enhance public safety regarding medication use and to remind healthcare professionals to be vigilant in identifying and managing these risks [4]. Group 2: Clinical Insights and Usage - Montelukast is commonly used for treating asthma, allergic cough, and allergic rhinitis, and has been on the market since 1998, with several generics approved in China following the expiration of its patent [4]. - Despite the potential for adverse reactions, experts emphasize that Montelukast remains an important medication for asthma treatment, and patients should not panic or discontinue use without consulting a physician [5]. - The recommended dosages for children include 4 mg and 5 mg formulations, with specific guidelines for age groups to minimize risks associated with overdose [5].
儿童常用哮喘药被要求增加抑郁和自杀倾向警示语 专家:确实会有副反应存在,但不必太过恐慌
Xin Lang Cai Jing·2025-12-25 14:16