Impact of FDA Black Box Warning on Psychotropic Drug Use in Noninstitutionalized Elderly Patients Diagnosed With Dementia: A Retrospective Study.

BACKGROUND: The study seeks to investigate the impact of Food and Drug Administration's black box warning (BBW) on the use of atypical antipsychotics (AAP) and nonantipsychotic psychotropic alternatives in noninstitutionalized elderly population diagnosed with dementia.

METHOD: The Medical Expenditure Panel Survey (2004 through 2007) was utilized as the data source. Medication use in elderly patients (≥65 years) was defined as taking at least 1 medication for dementia. We performed a statistical comparison of prewarning (2004-2005) and postwarning (2006-2007) periods with respect to AAP and nonantipsychotic psychotropic use to examine the impact of labeling changes.

RESULTS: A bivariate analysis did not yield statistically significant change in either the AAP or nonantipsychotic psychotropic use, pre- versus postwarning. However, multivariate logistic-regression analyses revealed greater odds for antidementia (odds ratio [OR] = 1.976, P = .0195) and benzodiazepine (OR = 3.046, P = .0227) medication use in postwarning period compared to the prewarning period.

CONCLUSION: The regulatory warnings and labeling changes regarding off-label use of AAPs in dementia treatment showed minimal impact on their actual use in noninstitutionalized populations. A corresponding increase in the use of nonantipsychotic psychotropics explains that BBW might have resulted in a compensatory shift in favor of benzodiazepines and antidementia medications. Additional research should be conducted to examine the long-term impact of BBW on antipsychotic prescribing changes.