美国 FDA 加强对孟鲁司特引发严重神经精神事件的风险警告，并建议对于变应性鼻炎限制使用
美国食品药品监督管理局（Food and Drug Administration, FDA）加强对孟鲁司特（一种白三烯受体拮抗剂）引发严重精神行为事件和情绪相关改变的风险警告。对已提交病例报道和已发表观察性和动物研究进行回顾，并对 FDA 安全性数据进行观察性研究后，FDA 重新评估了孟鲁司特的风险和获益，从而采取措施。
对于变应性鼻炎，FDA 认定孟鲁司特应当用于其他抗过敏药物未能有效治疗，或对于其他抗过敏药物无法耐受者。
神经精神事件（包括自杀意念或行为）风险警告已写入孟鲁司特处方信息，但许多医疗卫生专业人士和患者/照护者仍未意识到这一风险。
孟鲁司特应用指征为缓解变应性鼻炎症状、哮喘预防和长期治疗，以及预防运动性支气管痉挛急性发作。
原始更新来源external link opens in a new window
小结
定义
病史和体格检查
诊断性检查
治疗流程
撰稿人
作者
Regent
American College of Allergy, Asthma & Immunology
Medical Director
American Academy of Allergy, Asthma & Immunology Registry
Assistant Clinical Professor of Medicine
Medical College of Wisconsin
Adjunct Clinical Instructor
College of Nursing
University of Wisconsin-Milwaukee
Executive Director
Fight Asthma Milwaukee Allies
Allergy, Asthma & Sinus Center
Milwaukee
WI
利益声明
GCS has taken part in sponsored research for the ALK clinical trial of the house dust mite SLIT tablet for use in paediatric patients. He is a member of the Joint Task Force on Practice Parameters Workgroup on the Allergic Rhinitis Practice Parameter.
Dr Gary C. Steven would like to gratefully acknowledge Dr Alexander Greiner, a previous contributor to this topic.
利益声明
AG has received grant/research support from: Astra Zeneca; Boehringer Ingelheim; Cephalon Circassia Ltd; Clement Clarke Cytos biotechnology; GlaxoSmithKline; Glenmark Specialty, S.A.; Hoffman-LaRoche/Genentech; HRA/Novartis; Janssen Research & Development; Kalypsys , Inc.; Lupin; Merck; Mylan Pharmaceuticals, Inc.; Nestle (Nestec Ltd); Novartis Ono Pharmaceutical Co., Ltd.; Perrigo; Rigel Pharmaceuticals, Inc.; Roxane Laboratories Inc.; Shionogi Inc.; Sunovion TEVA Branded Pharmaceutical Products; UBC (United Biosource Corporation)/Amgen Pharmaceuticals; and sponsorship for pharmaceutical trials from Allergen Research Corporation/Aimmune Therapeutics, Inc. and Astra Zeneca.
同行评议者
Clinical Immunology Coordinator
Division of Rheumatology, Immunology and Allergy
Winthrop-University Hospital
Mineola
NY
利益声明
MDL declares that he has no competing interests.
Consultant Allergist/Rhinologist
Allergy & Rhinology Department
Royal National Throat, Nose and Ear Hospital
London
UK
利益声明
GS is a consultant/advisory board member for ALK, Britannia Pharmaceuticals, CMP Therapeutics, Groupo Uriach, GSK, Merck, Sanofi-Aventis, Schering Plough, and UCB. She has received research funds from ALK, GSK, UCB, and Schering Plough. She has given talks for ALK, GSK, Merck, Schering Plough, and UCB and has co-written articles for Schering Plough and GSK.
内容使用需遵循免责声明