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

Objective: Identify trends in adverse drug reactions (ADRs) reported to the U.S. Food and Drug Administration's Adverse Event Reporting Systemin 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.