Black box warnings accelerate reduced antipsychotic use in dementia

February 24, 2011

The rate of decline in the use of atypical antipsychotics in outpatients with dementia accelerated following a black box warning by FDA, according to a multicenter study of national Veterans Affairs data.

The rate of decline in the use of atypical antipsychotics in outpatients with dementia accelerated following a black box warning by FDA, according to a multicenter study of national Veterans Affairs data.

The researchers studied the changes in the use of atypical and conventional antipsychotics in 254,564 patients aged 65 years and older with dementia across 3 periods: no warning (1999-2003), early warning (2003-2005), and black box warning (2005-2007).  In 2005, FDA warned that there was a link between increased mortality and the use of atypical antipsychotics in dementia.

Data reveal that in 1999, 17.7% of patients were using atypical or conventional antipsychotics. Overall usage during the no-warning period began to decline (rate per quarter, -0.12%; 95% CI, -0.16 to -0.07; P<.001). The decline continued following the black box warning (rate, -0.26%; 95% CI, -0.34 to -0.18; P<.001). There was a significant difference between the early and black box warning periods (P=.006). Atypical antipsychotic use increased during the no-warning period (rate, 0.23; 95% CI, 0.17–0.30; P<.001), started to decline during the early-warning period (rate, -0.012; 95% CI, -0.14 to 0.11; P=.85), and more sharply declined during the black box warning period (rate, -0.27; 95% CI, -0.36 to-0.18; P<.001).

Specifically, olanzapine and risperidone use declined during the early-warning period and quetiapine use increased. However, use of all 3 antipsychotics declined during the black box warning period.

The study, "Trends in Antipsychotic Use in Dementia 1999-2007," appears in the February 2011 issue of the Archives of General Psychiatry.