A Comparison of Pediatric and Adult Safety Studies for Antipsychotic and Antidepressant Drugs Submitted to the United States Food and Drug Administration

• Published in: The Journal of pediatrics Vol. 208; pp. 236 - 242.e3
• Main Authors: Liu, Xiaomei I., Schuette, Paul, Burckart, Gilbert J., Green, Dionna J., La, Julie, Burnham, Janelle M., Rakhmanina, Natella, Robb, Adelaide, Huang, Shiew Mei, van den Anker, John N.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.05.2019
• Subjects: Adolescent; Adult; adverse drug effects; antidepressant; Antidepressive Agents - adverse effects; antipsychotic; Antipsychotic Agents - adverse effects; Child; Clinical Trials as Topic; drug development; Drug-Related Side Effects and Adverse Reactions - epidemiology; Humans; Incidence; Patient Safety; pediatric; Pediatrics; regulatory; Risk; United States; United States Food and Drug Administration; US FDA; United States; FAERS; FDA; RD; adverse drug effects; regulatory; antidepressant; drug development; antipsychotic; US FDA; pediatric; ADR

To examine the differences in the adverse drug reaction (ADR) profile of antipsychotic and antidepressant agents between pediatric and adult patients in studies submitted to the Food and Drug Administration (FDA) during the drug development process. Clinical trials in adult and pediatric patients we...