Core Viewpoint - The National Medical Products Administration (NMPA) has announced a unified revision of the instructions for Montelukast formulations, highlighting the potential neuropsychiatric adverse reactions associated with the drug [1] Group 1: Regulatory Changes - The NMPA's announcement includes a warning that neuropsychiatric adverse reactions have been reported in patients of all ages taking Montelukast, including severe reactions such as depression and suicidal tendencies [1] - It is advised that if neuropsychiatric symptoms occur during treatment, the medication should be discontinued and medical attention sought [1] - The revision also mandates the addition of stuttering as a reported adverse reaction based on post-marketing experience [1] Group 2: Expert Opinions - Ji Lianmei, founder of "Ask the Pharmacist," stated that Montelukast is not the first-line treatment for allergic rhinitis and asthma [1] - The incidence of psychiatric side effects, such as irritability and attention abnormalities, is reportedly higher in children [1] - It is emphasized that both adults and children should discontinue the medication and seek medical help if any neuropsychiatric symptoms arise, and a thorough assessment of benefits versus risks should be conducted before use [1]
国家药监局修订孟鲁司特制剂说明书 警示语应包含精神副作用
Bei Jing Shang Bao·2025-12-23 04:54