Since 1998, montelukast has been licensed for the treatment of seasonal allergic rhinitis and asthma in people aged over 6 months. In children in particular, montelukast was welcomed as a steroid-sparing alternative to traditional asthma-preventer drugs, which could be taken just once daily, and which did not require the use of an inhaler. Although recent systematic reviews have shown regular inhaled corticosteroids (ICS) to be more effective than montelukast in controlling asthma symptoms, some children do demonstrate preferential response to montelukast.1 2 Consequently, current asthma guidelines still recommend montelukast as an optional alternative to ICS for mild-to-moderate asthma as monotherapy in children.3 While several studies and even prescribing information cite a wide range of potential neuropsychiatric side effects, the frequency of occurrence and exact nature of these side effects are not well defined and unfortunately not always well understood or recognised by healthcare professionals.4 In 2019 and then again in 2024, the UK Medicines and Healthcare products Regulatory Agency issued warnings and advice drawing attention to these problems.5 6 Similarly, in the USA, the Food and Drug Administration (FDA) issued a ‘black box warning’ for montelukast in 2020, drawing attention to documented mental and behavioural health risks associated with the use of the drug.7 More recently in 2024, the New York State district attorney called on the FDA to take urgent action to protect children from the risks of montelukast, including writing to …

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孟鲁司特的神经精神副作用：是时候改变处方实践了？


自 1998 年以来，孟鲁司特已被批准用于治疗 6 个月以上人群的季节性过敏性鼻炎和哮喘。特别是在儿童中，孟鲁司特作为传统哮喘预防药物的类固醇减少替代品而受到欢迎，传统哮喘预防药物每天只需服用一次，并且不需要使用吸入器。尽管最近的系统评价表明，常规吸入皮质类固醇 （ICS） 在控制哮喘症状方面比孟鲁司特更有效，但一些儿童确实表现出对孟鲁司特的优先反应.1 2 因此，目前的哮喘指南仍然建议孟鲁司特作为儿童轻中度哮喘 ICS 的可选替代药物.3 虽然一些研究甚至处方信息引用了广泛的潜在神经精神副作用， 这些副作用的发生频率和确切性质尚不明确，遗憾的是，医疗保健专业人员并不总是很好地理解或认识到这些副作用。4 在 2019 年和 2024 年，英国药品和保健产品监管局发布了警告和建议，提请人们注意这些问题。6 同样，在美国，美国食品和药物管理局 （FDA） 于 2020 年发布了孟鲁司特的“黑框警告”， 提请注意与使用该药物相关的有记录的心理和行为健康风险。7 最近在 2024 年，纽约州地方检察官呼吁 FDA 采取紧急行动保护儿童免受孟鲁司特的风险，包括写信给......