Benefits, Harms With Off-Label Atypical Antipsychotic Use

Adverse events common; favorable response varies with drug and off-label condition being treated

TUESDAY, Sept. 27 (HealthDay News) -- There are varying benefits and adverse effects from using atypical antipsychotic medications for conditions which do not have labeling and marketing approval by the U.S. Food and Drug Administration (off-label), according to a meta-analysis published in the Sept. 28 issue of the Journal of the American Medical Association.

Alicia Ruelaz Maher, M.D., from the Southern California Evidence-Based Practice Center in Santa Monica, and colleagues reviewed available literature to investigate the efficacy and safety of atypical antipsychotic medications used for off-label conditions. A total of 162 trials with efficacy outcomes and 231 trials or large observational studies (sample sizes greater than 1,000 patients) with adverse events were included in the analysis. The trials compared atypical antipsychotic medications for adult off-label conditions with either placebo or other pharmacotherapy.

The investigators found that aripiprazole, olanzapine, and risperidone were associated with small but significant effect sizes ranging from 0.12 to 0.20 in 14 placebo-controlled trials on elderly patients with dementia and symptoms of psychosis, mood alterations, and aggression. Pooled analysis of three trials for generalized anxiety disorder showed that quetiapine had 26 percent higher likelihood of a favorable response than placebo. Risperidone was 3.9-fold more likely to give favorable response than placebo in obsessive compulsive disorder. Increased risks of death, stroke, extrapyramidal symptoms, and urinary tract symptoms were the more likely adverse events in elderly, while weight gain (particularly with olanzapine), fatigue, sedation, akathisia (for aripiprazole), and extrapyramidal symptoms were more likely in non-elderly patients.

"Benefits and harms vary among atypical antipsychotic medications for off-label use," the authors write.

One of the study authors disclosed a financial relationship with Eli Lilly.

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