孟鲁司特困局：被神化的止咳药与全年龄段的副作用

Core Viewpoint - Montelukast, once regarded as a "cough remedy," is now under scrutiny due to its psychiatric side effects, leading to a shift in its usage from a widely accepted treatment to one that requires careful evaluation and cautious application [1][10]. Regulatory Changes - The National Medical Products Administration (NMPA) has revised the drug's labeling to include warnings about potential severe adverse reactions such as depression and suicidal tendencies, advising immediate cessation and medical consultation if symptoms arise [2][4]. Usage Patterns - Despite the warnings, Montelukast is still widely used for common symptoms like cough and rhinitis, with the original drug "Singulair" selling over 2 million boxes on a single platform [1][10]. - A study indicated that only 13.88% of prescriptions for Montelukast adhered to its approved indications, with off-label use reaching 86.12%, particularly for conditions like Chronic Obstructive Pulmonary Disease (COPD) and bronchitis [5][6]. Market Dynamics - There are over 60 approved Montelukast products in China, produced by numerous companies, indicating a significant market presence [8]. - The tightening of prescription practices has led to a shift in clinical attitudes, with doctors now requiring clear therapeutic necessity and informed consent from parents before prescribing Montelukast, especially for children [10][11]. Patient Concerns - Many families face a dilemma between the drug's cough-relief efficacy and its associated risks, leading to increased anxiety about treatment options [2][10]. - There is a growing recognition among the public that Montelukast should not be viewed as a universal "cough remedy," but rather as a medication that requires careful assessment and clear communication of risks [11].