年销10亿元的“儿童止咳药”，新增风险提示意味着什么？

Core Viewpoint - The recent announcement by the National Medical Products Administration (NMPA) regarding the pediatric medication Montelukast has raised significant concerns about its safety, particularly regarding neuropsychiatric side effects, prompting a reevaluation of its use in children [2][5][16]. Group 1: Drug Safety Concerns - Montelukast, a commonly used pediatric medication with annual sales exceeding 1 billion yuan, has been linked to neuropsychiatric adverse reactions, including depression and suicidal tendencies, as well as stuttering [2][16]. - The FDA had previously issued a black box warning in 2020, indicating serious mental health risks associated with Montelukast, which had not been adequately addressed in China until now [3][17]. - The recent NMPA announcement has led to widespread discussions among parents and healthcare professionals about the safety of this long-used pediatric drug [3][5]. Group 2: Clinical Usage and Misuse - Montelukast is often prescribed for common respiratory symptoms in children, leading to its perception as a "common medication" for cough and nasal congestion, despite not being a first-line treatment for these conditions [10][12]. - Studies indicate that a significant percentage of prescriptions for Montelukast are inappropriate, with 96.26% of cases showing unsuitable indications or dosages [13]. - The drug's misuse is attributed to various factors, including parental reluctance to use inhaled corticosteroids and the convenience of oral medication [14][25]. Group 3: Regulatory and Clinical Response - The delay in updating Montelukast's safety information in China reflects broader issues in drug safety management, including slow responses to international warnings and the need for better communication of risks to healthcare providers [24][25]. - Experts emphasize the importance of balancing treatment benefits against potential side effects, advocating for more timely risk communication to clinicians and patients [5][20]. - The ongoing debate surrounding Montelukast highlights the necessity for continuous monitoring and evaluation of drug safety, as well as the need for regulatory bodies to act swiftly on emerging safety signals [28].