Assessing Adverse Drug Reactions from Psychotropic Medications Reported to the U.S. Food and Drug Administration in Older Adults

• Published in: The American journal of geriatric psychiatry Vol. 27; no. 2; pp. 181 - 185
• Main Authors: Gray, Matthew P., Dziuba, Gabrielle, Quach, Karen, Wong, Adrian, Smithburger, Pamela L., Seybert, Amy L., Kane-Gill, Sandra L.
• Format: Journal Article
• Language: English
• Published: England Elsevier Inc 01-02-2019; Elsevier Limited
• Subjects: adverse drug event; adverse drug reaction; Aged; Aged, 80 and over; Drug Monitoring - statistics & numerical data; drug safety; Drug therapy; Drug-Related Side Effects and Adverse Reactions - etiology; elderly; FDA approval; Female; Humans; Male; Middle Aged; Older people; Psychotropic drugs; Psychotropic Drugs - adverse effects; United States; United States Food and Drug Administration - statistics & numerical data; United States; United States > US; Psychotropic drugs; adverse drug event; adverse drug reaction; elderly; drug safety
• ISSN: 1064-7481; 1545-7214
• DOI: 10.1016/j.jagp.2018.09.013

Identify trends in adverse drug reactions (ADRs) reported to the U.S. Food and Drug Administration's Adverse Event Reporting System in three subpopulations of older adults (ages 55–64, 65–74, 75+) receiving psychotropic medications.
Almost 12 years of ADR reports were compiled for adults over 55 years of age receiving psychotropic medications with known side effect profiles. A comparison of the frequency of ADRs reported, odds ratios (ORs), and 95% confidence intervals (CIs) between subpopulations to the whole population of patients aged 55+ was conducted.
ADRs reported in three subpopulations of older adults differed significantly when receiving the same psychotropic medications. For example, reports of increased blood glucose (OR, 1.8, CI, 1.4–2.2) were all significantly increased in the youngest population (55–64).
Current classification of age greater than 65 years when evaluating likely ADRs in older adults using psychotropic medications may be inadequate and require further assessment by subpopulations of older adults.