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Black Box Warnings Linked to Reduced Antipsychotic Use

Last Updated: February 09, 2011.

The use of atypical antipsychotic drugs for neuropsychiatric symptoms of dementia began to decline in 2003, and was temporally associated with the Food and Drug Administration black box advisory, according to a study published in the February issue of the Archives of General Psychiatry.

WEDNESDAY, Feb. 9 (HealthDay News) -- The use of atypical antipsychotic drugs for neuropsychiatric symptoms of dementia began to decline in 2003, and was temporally associated with the Food and Drug Administration black box advisory, according to a study published in the February issue of the Archives of General Psychiatry.

Helen C. Kales, M.D., from the Serious Mental Illness Treatment, Research, and Evaluation Center in Ann Arbor, Mich., and colleagues studied changes in atypical and conventional antipsychotic drug use in 254,564 outpatients aged 65 years and older with dementia, in three time periods between 1999 and 2007. From 1999 to 2003, there were no medication warnings; from 2003 to 2005, early warnings were given; and from 2005 to 2007 black box warnings were in place.

The researchers found that, in 1999, 17.7 percent of dementia patients were treated with atypical or conventional antipsychotics. Use started decreasing between 1999 and 2003 (rate per quarter, –0.12 percent), and continued from 2005 to 2007 (rate, –0.26 percent) with a significant difference between early and late in this time period. Atypical antipsychotic use increased from 1999 to 2003 (rate, 0.23), but decreased from 2003 to 2005 (rate, –0.012), and decreased significantly from 2005 to 2007 (rate, –0.27). A small but significant increase in anticonvulsant prescriptions was seen during the black box warning period.

"Use of atypical antipsychotics for patients with dementia began to decline significantly in 2003, and the U.S. Food and Drug Administration advisory was temporally associated with a significant acceleration in the decline," the authors write.

One of the study authors disclosed a financial relationship with various pharmaceutical companies, including Pfizer, Eli Lilly, AstraZeneca, and Novartis.

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