寒假来临，又到了不少学生集中治疗痤疮（俗称"痘痘"）的高峰期。近日，被誉为"战痘神药"的异维A酸，成了众多患者关注的焦点。 1月6日，国家药品监督管理局发布公告，对异维A酸软胶囊说明书内容进行统一修订。在南方医科大学中西医结合医院皮肤医学中心，门诊已迎来第一波 青少年痤疮就诊潮，其中就有不少家长带着孩子前来咨询是否适用异维A酸。 这款"痤疮神药"可能影响性功能 异维A酸俗称"EVA"，是最近几年在网上走红的所谓"治痘神药"。目前市面上可见的异维A酸产品，既有口服胶囊，也有外用乳膏制剂。很多年轻人把异 维A酸当作战"痘"的法宝，社交媒体也倾向于宣传它的神奇疗效，而忽视或者淡化它的副作用，导致这个药出现了滥用。 最新发布的《异维A酸软胶囊说明书修订要求》明确其不良反应项应包含内分泌、消化、精神、生殖等数十项副作用提示，并修改与新增了两条注意事 项： 若出现抑郁、躁动，以及罕见的自杀、自杀意念和自杀企图等情况，患者应立即停药； 已有异维A酸可能引起性功能障碍的个例报告，个别患者停用异维A酸后性功能障碍相关症状仍长期存在，可能需要专科治疗。 此外，不良反应项还补充了内分泌、消化、肌肉骨骼等数十项副作用提示。国家药监局 ...

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].

Core Viewpoint - The National Medical Products Administration (NMPA) of China has announced a revision of the prescribing information for Montelukast formulations, mandating the inclusion of explicit warnings regarding neuropsychiatric adverse reactions, including depression and suicidal tendencies [1][2]. Group 1: Regulatory Changes - The revision is based on the results of adverse drug reaction monitoring and assessment [1]. - All Montelukast formulations, including tablets, chewable tablets, granules, and orally dissolving films, are subject to this revision, with the latter three being specifically for pediatric use [2]. - The NMPA requires all marketing authorization holders of Montelukast to revise the prescribing information by March 12, 2026, and to replace the labels of all manufactured products within nine months after the filing [3]. Group 2: Market Context - Montelukast, developed by Merck & Co., was first approved in 1998 and is a selective leukotriene receptor antagonist indicated for the prevention and long-term treatment of asthma in children aged 2 to 14 years [2]. - Following the expiration of its patent, various generic versions have emerged globally, with over 60 approved marketing numbers in China from manufacturers such as Qilu Pharmaceutical, Tianyu Pharmaceutical, and others [2]. - In 2023, Montelukast's sales in Chinese public medical institutions exceeded 1 billion yuan, ranking among the top five chemical drugs for obstructive airway diseases [2].

Core Viewpoint - The National Medical Products Administration (NMPA) of China has announced a revision of the prescribing information for Montelukast formulations to enhance public safety regarding medication use, particularly concerning neuropsychiatric adverse reactions [2][4]. Group 1: Regulatory Changes - The NMPA's announcement includes a unified revision of the prescribing information for Montelukast formulations, which encompasses Montelukast sodium tablets, chewable tablets, granules, and orally dissolving films [2]. - The revised prescribing information will include warnings about neuropsychiatric adverse reactions reported across all age groups, including severe reactions such as depression and suicidal tendencies [4]. Group 2: Clinical Implications - Montelukast, developed by Merck and first approved in 1998, is a selective leukotriene receptor antagonist primarily used for treating asthma and allergic rhinitis [7]. - The drug is commonly used in children due to concerns about the side effects of inhaled corticosteroids, although it may cause side effects such as drowsiness, mental excitement, nightmares, and even depressive tendencies [7]. - Medical professionals are advised to conduct a thorough benefit/risk analysis based on the newly revised prescribing information when selecting medications for patients [9].

Core Viewpoint - The National Medical Products Administration (NMPA) has announced a unified revision of the instructions for Montelukast formulations to enhance public medication safety, highlighting the potential neuropsychiatric adverse reactions associated with the drug [1] Group 1: Regulatory Changes - The NMPA's decision is based on the evaluation of adverse drug reactions, aiming to ensure safer medication use among the public [1] - The revised warning will include reports of neuropsychiatric adverse reactions across all age groups, including severe reactions such as depression and suicidal tendencies [1] Group 2: Patient Guidance - The new instructions recommend that if neuropsychiatric symptoms occur during treatment with Montelukast, the medication should be discontinued and medical attention sought [1] - Patients and caregivers are advised to be vigilant for neuropsychiatric adverse reactions and to inform healthcare providers if related symptoms arise during the medication period [1]

Core Viewpoint - The National Medical Products Administration (NMPA) of China has announced a unified revision of the product instructions for Montelukast formulations to enhance public medication safety, highlighting potential neuropsychiatric adverse reactions associated with the drug [3][9]. Group 1: Drug Safety and Revisions - The revised instructions will include warnings about neuropsychiatric adverse reactions reported across all age groups, including severe reactions such as depression and suicidal tendencies [3][4]. - Patients experiencing neuropsychiatric symptoms during Montelukast treatment are advised to discontinue use and seek medical attention [3][4]. Group 2: Market and Usage Insights - Montelukast is a common asthma treatment drug, initially developed by Merck and approved for sale in foreign markets in 1998. Following the expiration of its patent in China, several generic versions have been approved [8]. - In 2023, Montelukast's sales in Chinese public medical institutions exceeded 1 billion yuan, ranking among the top five obstructive airway disease medications [8]. - The drug is frequently used in children due to concerns about the side effects of inhaled corticosteroids, although it can cause side effects such as drowsiness and potential depressive tendencies [8]. Group 3: Regulatory and Clinical Implications - The NMPA's requirement for the revision aligns with previous warnings issued by the U.S. FDA regarding the drug, indicating a proactive approach to drug safety [9]. - The drug's marketing authorization holders are expected to conduct in-depth research on the mechanisms of newly identified adverse reactions and implement effective measures for safety training and communication [9].

Core Viewpoint - The National Medical Products Administration (NMPA) of China has announced a unified revision of the product instructions for Montelukast formulations to enhance public medication safety, following reports of neuropsychiatric adverse reactions associated with the drug [1][2]. Group 1: Regulatory Changes - The NMPA's announcement includes a requirement for the product instructions to warn about neuropsychiatric adverse reactions reported across all age groups, including severe reactions such as depression and suicidal tendencies [1]. - The revised instructions will advise that if neuropsychiatric symptoms occur during treatment, the medication should be discontinued and medical attention sought [1][3]. Group 2: Market Context - Montelukast is a common asthma treatment drug, originally developed by Merck and approved for use in 1998. With the expiration of its patent in China, several generic versions have been approved for sale [2]. - In 2023, Montelukast's sales in Chinese public medical institutions exceeded 1 billion yuan, ranking it among the top five obstructive airway disease medications [2]. Group 3: Clinical Insights - Montelukast is primarily used as an adjunct treatment for asthma, particularly in children, who often prefer it over inhaled corticosteroids due to concerns about side effects [2]. - While some patients may experience side effects such as drowsiness or mood disturbances, most can recover after discontinuation of the drug, with few experiencing long-term effects [2].