Safety and efficacy of off-label atypical antipsychotic use

January 01, 0001

Safety and efficacy of off-label atypical antipsychotic use

Atypical antipsychotics are used off-label in situations such as agitation, anxiety, and obsessive-compulsive disorder. These US researchers performed a systematic review the safety and efficacy of atypical antipsychotics medications in off-label uses. They searched PubMed, EMBASE, CINAHL, PsycInfo, Cochrane DARE, and CENTRAL for English language controlled trials of risperidone, olanzapine, quetiapine, aripiprazole, ziprasidone, asenapine, iloperidone, or paliperidone in off-label conditions in adult patients. They included large observational studies to characterize adverse events.

The researchers found: "Among 14 placebo-controlled trials of elderly patients with dementia reporting a total global outcome score that includes symptoms such as psychosis, mood alterations, and aggression, small but statistically significant effects sizes ranging from 0.12 and 0.20 were observed for aripiprazole, olanzapine, and risperidone. For generalized anxiety disorder, a pooled analysis of 3 trials showed that quetiapine was associated with a 26% greater likelihood of a favorable response (defined as at least 50% improvement on the Hamilton Anxiety Scale) compared with placebo. For obsessive-compulsive disorder, risperidone was associated with a 3.9-fold greater likelihood of a favorable response (defined as a 25% improvement on the Yale-Brown Obsessive Compulsive Scale) compared with placebo. In elderly patients, adverse events included an increased risk of death (number needed to harm [NNH

The researchers concluded: "Benefits and harms vary among atypical antipsychotic medications for off-label use. For global behavioral symptom scores associated with dementia in elderly patients, small but statistically significant benefits were observed for aripiprazole, olanzapine, and risperidone. Quetiapine was associated with benefits in the treatment of generalized anxiety disorder, and risperidone was associated with benefits in the treatment of obsessive-compulsive disorder. However, adverse events were common."

This study provides important characterization of the safety and efficacy of atypical anti-psychotics in a variety of off-label uses.

For the full abstract, click here.

JAMA 306(12):1359-1369, 28 September 2011 © 2011 American Medical Association
Efficacy and Comparative Effectiveness of Atypical Antipsychotic Medications for Off-Label Uses in Adults. Alicia Ruelaz Maher, Margaret Maglione, Steven Bagley, et al.

Category: P. Psychological. Keywords: atypical antipsychotics, agitation, OCD, anxiety, off-label, systematic review and meta-analysis, journal watch.
Synopsis edited by Dr Paul Schaefer, Toledo, Ohio. Posted on Global Family Doctor 11 October 2011

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