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Off-Label Use of Atypical Antipsychotics: An Update [Internet]

Off-Label Use of Atypical Antipsychotics: An Update [Internet]

Comparative Effectiveness Reviews - Agency for Healthcare Research and Quality (US)

Version: September 2011

Summary and Discussion

We conducted an extensive literature search, data abstraction, and meta-analyses, whenever possible, to assess the efficacy, comparative effectiveness, and safety of atypical antipsychotics for off-label indications. Since the submission of our original comparative effectiveness review (CER)in 2006, many new high-quality controlled trials have been published; we were able to add many to our prior quantitative analyses and conduct additional analyses on new conditions and adverse events. In this chapter, we describe the limitations of our review and meta-analyses and then present our conclusions. We also discuss the implications of our findings for future research.

Executive Summary

Antipsychotics medications are approved by the U.S. Food and Drug Administration (FDA) for treatment of schizophrenia and bipolar disorder. These medications are commonly divided into two classes, reflecting two waves of historical development: the conventional antipsychotics and the atypical. The conventional antipsychotics served as the first successful pharmacologic treatment for primary psychotic disorders such as schizophrenia. Having been widely used for decades, the conventional antipsychotics also produced various side effects requiring additional medications, which spurred the development of the atypical antipsychotics.


In total, EPC reviewers selected 1,144 relevant titles for abstract review out of 9,414 titles. Electronic literature searches identified 9,207 titles, 216 were identified from reference mining, and 23 others not found in the electronic searches were included in Scientific Information Packets sent by drug manufacturers (Figure 2). Eighty-one were rejected through our abstract review, and 15 could not be obtained. Thus, 1,048 full-text articles/reports were available for short form screening.

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