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Cited by 423

The DOI matches its Crossref record; 17 of the 17 references it cites were found in a registry or an index.

Increasing off‐label use of antipsychotic medications in the United States, 1995–2008

Open access
Alexander, G. C., Gallagher, S. A., Mascola, A., Moloney, R. M., Stafford, R. S.·2011·Pharmacoepidemiology and Drug Safety

Abstract

Objective: To evaluate patterns of antipsychotic use. Design, setting, and measurements: We used nationally representative data from the IMS Health National Disease and Therapeutic Index to describe outpatient antipsychotic use. The primary outcome was the volume of visits where antipsychotics were used for specific indications (treatment visits). We also quantified use without U.S. Food and Drug Administration approval (off‐label use) and off‐label use with compendium data suggesting an uncertain evidence base. Results: Antipsychotic use increased from 6.2 million (M) treatment visits (95% CI, 5.4–7.0) in 1995 to 16.7 M visits (15.5–18.2) in 2006, then declined to 14.3 M visits (13.0–15.6) by 2008. A shift occurred from typical agents in 1995 (84% of all antipsychotic visits) to atypical agents by 2008 (93%). As they declined, typical medications shifted toward use in schizophrenia (30% in 1995 to 48% 2008). In contrast, use of atypical agents expanded for bipolar affective disorder (10 to 34%), remained stable for depression (12 to 14%), and declined for schizophrenia (56 to 23%). Overall, antipsychotic use for indications without FDA approval increased from 4.4 M visits in 1995 to 9.0 M in 2008. The estimated cost associated with off‐label use in 2008 was US$6.0 billion. Conclusions: Atypical use has grown far beyond substitution for the now infrequently used typical agents. Antipsychotics are increasingly used for conditions where FDA approval and associated clinical evidence is less certain. Despite the value of innovation, the benefits of widening atypical antipsychotic use should be weighed against their cost, regulatory status, and incomplete nature of available evidence. Copyright © 2011 John Wiley & Sons, Ltd.

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Metadata

Authors
Alexander, G. C., Gallagher, S. A., Mascola, A., Moloney, R. M., & Stafford, R. S.
Venue
Pharmacoepidemiology and Drug Safety
Publisher
Wiley
Published
2011-01-06
Volume
20
Issue
2
Pages
177-184
ISSN
  • 1053-8569 (ISSN-L)
  • 1099-1557
OpenAlex
W2164142166
Cited by
423
References
17
FWCI
26.79
Type
journal article
Language
en
Open access
green

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CoChat. (2026). Citation check: Increasing off‐label use of antipsychotic medications in the United States, 1995–2008. https://app.cochat.ai/papers/10.1002/pds.2082
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Alexander, G. C., Gallagher, S. A., Mascola, A., Moloney, R. M., & Stafford, R. S. (2011). Increasing off‐label use of antipsychotic medications in the United States, 1995–2008. Pharmacoepidemiology and Drug Safety. https://doi.org/10.1002/pds.2082

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