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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

Introduction

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.

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.

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.

Results

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.

Methods

The current report is designed to update Efficacy and Comparative Effectiveness of Atypical Antipsychotics for Off-label Use, which the Agency for Healthcare Research and Quality (AHRQ) published in 2006. Since this is an update, we tried to be as consistent as possible with regard to the general topics, scope of work, and analytical methods, but made revisions to reflect the important changes mentioned in the introduction. The key questions were posted on the AHRQ Effective Health Care Program Web site to obtain public comments which were considered when focusing the scope of this report. The present evidence report focuses on eight Food and Drug Administration (FDA)-approved atypical antipsychotics (clozapine was excluded because of its documented severe or life-threatening side effects) used for the following psychiatric conditions: anxiety, attention-deficit hyperactivity disorder (ADHD), dementia and severe geriatric agitation, depression, eating disorder, insomnia, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), personality disorders, substance abuse, and Tourette's syndrome. We reviewed all conditions among adults (defined as 18 years old and older); for ADHD, eating disorders, insomnia, and Tourette's syndrome, children (younger than 12 years old) and adolescents (12–17 years old) were also included. Autism, which was included in the original study, is included in a report on the comparative effectiveness of typical and atypical antipsychotics for on-label indications conducted by another Evidence-based Practice Center. Thus, autism is excluded from the present review.

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