ORIGINAL ARTICLESOff-label antidepressant prescription in pediatric outpatients based on China Food and Drug Administration and Food and Drug Administration regulations a Chinese retrospective studyDeng, Shuhuaa; Zhu, Xiuqinga; Sun, Binb; Hu, Jinqinga; Shang, Deweia; Chen, Weijiaa; Lu, Haoyanga; Ni, Xiaojiaa; Zhang, Minga; Wang, Zhanzhanga; Wen, Yuguana; Qiu, Changa Author Information aDepartment of Clinical Pharmacy bDepartment of Neuropsychiatric Research Institute, The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), Guangzhou, China Correspondence to Chang Qiu, MSc, Department of Clinical Pharmacy, The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), 36 MingXin Road, Guangzhou 510370, China Tel: +86 20 8126 8195; fax: +86 20 8189 1391; e-mail: [email protected] Received June 14, 2017 Accepted September 27, 2017 International Clinical Psychopharmacology: May 2018 - Volume 33 - Issue 3 - p 172-179 doi: 10.1097/YIC.0000000000000216 Buy Metrics Abstract The objective of this study was to evaluate the prevalence and relative risk of off-label prescription of antidepressants in Chinese pediatric outpatients according to China Food and Drug Administration (C-FDA) and USFDA regulations. Medical records of 18 459 pediatric outpatients were identified between 2013 and 2015. Patient characteristics, prevalence of off-label antidepressant prescriptions, and relative risk factors associated with off-label prescribing were analyzed. The results indicate that patients aged from 12 to 17 years account for 88.1% of antidepressant prescriptions, with the most commonly prescribed being sertraline (41.4%). In total, 90.0 and 84.1% of antidepressant prescriptions were off-labeled according to C-FDA and USFDA, respectively, and off-label indications was the most frequent type in this study. Depression was the most common indication for antidepressant treatment, followed by bipolar disorder and schizophrenia. Patients aged 12–17 years diagnosed with bipolar affective disorder have a high risk of off-label antidepressant prescription according to C-FDA regulations. Patients diagnosed with obsessive–compulsive disorder have a low risk of off-label antidepressant prescription according to both regulations. Therefore, future studies are recommended to collect evidence to safeguard appropriate prescribing of off-label antidepressants among pediatric patients. Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.