Core Viewpoint - Montelukast, once regarded as a "cough miracle drug," is now under scrutiny due to its potential psychiatric side effects, leading to a shift in its usage from a widely accepted treatment to one requiring careful evaluation and caution [1][3][9] Regulatory Changes - The National Medical Products Administration (NMPA) has revised the drug's labeling to include warnings about serious adverse reactions such as depression and suicidal tendencies, advising patients to seek medical attention if such symptoms occur [3][4] - The updated labeling emphasizes that adverse neuropsychiatric reactions have been reported across all age groups, and symptoms may persist if the drug is not discontinued [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][7] - 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 chronic obstructive pulmonary disease and bronchitis [5][6] Patient and Physician Perspectives - Many patients and their families face a dilemma between relying on Montelukast for its cough relief and the fear of its side effects, leading to increased anxiety about treatment options [3][8] - Some healthcare providers continue to recommend Montelukast despite known side effects, indicating a gap in awareness regarding its risks [6][9] Market Dynamics - There are over 60 approved Montelukast products in China, with a significant market presence, but the tightening of prescription practices is leading to a shift in how the drug is perceived and used [7][8] - The clinical application of Montelukast is becoming more cautious, with a focus on clear communication of potential risks to patients and their families [7][9] Alternative Treatments - Experts suggest that there are safer and effective alternatives for treating allergic conditions, including various non-prescription medications and nasal corticosteroids, but public perception of these alternatives remains a barrier [8][9] - The reluctance to use corticosteroids due to misconceptions about their safety may lead patients to continue using Montelukast, which poses higher risks [8]
孟鲁司特困局:被神化的止咳药