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.
FDA Approves Two More Denosumab Biosimilars, Conexxence and Bomyntra
March 27th 2025The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, as a result of a global settlement with Amgen, according to a company news release.
Read More
FDA Approves First Drug for Excess Hunger in Prader-Willi Syndrome
March 27th 2025Vykat XR will be available in April to treat the intense hunger that is a hallmark of the rare genetic disease Prader-Willi syndrome. The price is based on a patient’s weight, and the average patient in the clinical trials would have had an average annual cost of $466,200 for the first year.
Read More
FDA Approves Amvuttra for ATTR-CM in Extended Label
March 21st 2025This expanded indication for Amvuttra makes it the first and only FDA-approved treatment for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.
Read More