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
Section Head of Rhinology, Sinus, and Skull Base Surgery
Head and Neck Institute
Cleveland Clinic Foundation
Cleveland
OH
利益声明
RS is an author of a number of references cited in this topic.
Assistant Professor
Rhinology and Endoscopic Skull Base Surgery
Section of Otolaryngology - Head and Neck Surgery
Department of Surgery
University of Chicago Medicine & Biological Sciences
Chicago
IL
利益声明
CR declares that he has no competing interests.
Dr R Sindwani and Dr C Roxbury would like to acknowledge Dr J Antisdel, a previous contributor to this topic.
同行评议者
Professor
James H. Quillen College of Medicine
East Tennessee State University
Johnson City
TN
利益声明
RPB declares that he has no competing interests.
Assistant Professor of Otolaryngology - Head and Neck Surgery
St Louis University School of Medicine
St Louis
MO
利益声明
TS declares that he has no competing interests.
Chief
ENT Department
Istanbul Training and Research Hospital
Istanbul
Turkey
利益声明
OY declares that he has no competing interests.
Assistant Professor/Consultant
Academic Medical Center
Amsterdam
The Netherlands
利益声明
CG declares that he has no competing interests.
内容使用需遵循免责声明