摘要：尽管神经精神不良事件似乎并不常见, 而且在 SmPC 4.8 中已经有广泛的描述, 但仍要求 MAH 在第4.4 节中增加一个警告, 以进一步提高认识：在使用孟鲁司特期间可能发生神经精神事件，可能与药品有关, 可能需要采取进一步措施。要求 MAH 增加使用孟鲁司特期间可能发生神经精神事件的警告。

近日，欧盟药监局发布了《孟鲁司特定期安全评价报告》，包括3个内容：

• 要求 MAH 增加使用孟鲁司特期间可能发生神经精神事件的警告。
• 新增“语言障碍”的不良反应
• 要求更新 SmPC 和包装说明书

Based on the gathered cumulative data, theissue of neuropsychiatric ADRs deserves specific attention. Cases have beenreported in which various neuropsychiatric events have caused significanthindrance and suffering to patients before the symptoms have been recognized aslikely ADRs. Therefore, the possibility that neuropsychiatric events, evenrare, may occur, should be distinctly communicated to the healthcareprofessionals and patients. Even though neuropsychiatric adverse events seem tobe infrequent and are already widely described in the SmPC 4.8, the MAH isrequested to add a warning in section 4.4 in order to further increase theunderstanding and awareness that neuropsychiatric events possibly occurringduring montelukast use may be associated to the medicinalproduct and further actions may be necessary.

根据收集到的累积数据, 神经精神不良反应问题值得特别关注。据报告, 在症状被确认为可能的不良反应之前, 各种神经精神事件对患者造成了重大阻碍和痛苦。因此, 神经精神事件的可能性, 即使是罕见的, 也可能发生, 应该明确传达给医疗专业人员和患者。尽管神经精神不良事件似乎并不常见, 而且在 SmPC 4.8 中已经有广泛的描述, 但仍要求 MAH 在第4.4 节中增加一个警告, 以进一步提高认识：在使用孟鲁司特期间可能发生神经精神事件，可能与药品有关, 可能需要采取进一步措施。

A certain number of cases of dysphemia wasreported. The majority of these cases involved the paediatric population(aged 17 years and under), especially young children less than five years ofage. The time to onset was relatively short (median 8 days for PTDysphemia; 13 days for PT Speech disorder). Over half of theDysphemia cases described positive dechallenges(symptoms disappeared when the medication was discontinued), including 4positive rechallenged (symtoms reoccurred when the medication wasreadministered), all in children. Based on the review of these data, Dysphemiaand other closely related Speech disorders may be associated with montelukast.Whilst the Summary of Product Characteristics (SmPC) for montelukast currentlylists several psychiatric and nervous system reactions, Dysphemia is not listed as an adverse drug reaction (ADR). In light of the cumulative review analysis,the MAHs are requested to update the SmPC (section 4.8) and package leafletaccordingly.

报告了一定数量的语言障碍病例。这些病例大多涉及儿科人群 (17岁及以下), 特别是5岁以下的幼儿。发病时间相对较短。根据对这些数据的回顾, 口吃和其他密切相关的言语障碍可能与孟鲁司特有关。虽然孟鲁司特的产品特性摘要 (SmPC) 目前列出了几种精神和神经系统反应, 但不列为药物不良反应(ADR)。根据累积审查分析, 要求 MAHs 更新 SmPC (第4.8 节) 和包装说明书。

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