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

Matthew P Gray Gabrielle Dziuba Karen Quach Adrian Wong Pamela L Smithburger Amy L Seybert Sandra L Kane-Gill

Am J Geriatr Psychiatry

Department of Pharmacy and Therapeutics (MPG, GD, KQ, AW, PLS, ALS, SLK), University of Pittsburgh School of Pharmacy, Pittsburgh; Department of Pharmacy (PLS, SLK), University of Pittsburgh Medical Center Presbyterian, Pittsburgh. Electronic address:

Published: February 2019

The study aimed to identify trends in adverse drug reactions (ADRs) among older adults (ages 55+) using psychotropic medications by analyzing almost 12 years of data from the FDA's Adverse Event Reporting System.
Results showed that different age subpopulations (55-64, 65-74, and 75+) reported distinct ADRs, with the youngest group (55-64) showing significantly higher reports of increased blood glucose levels.
The findings suggest that the current practice of categorizing ADRs in those over 65 may overlook important variations in response among younger older adults, indicating the need for a more nuanced approach to assessing ADRs in these subpopulations.

Objective: 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.

Methods: 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.

Results: 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).

Conclusion: 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.

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http://dx.doi.org/10.1016/j.jagp.2018.09.013	DOI Listing

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