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Increasing off-label use of antipsychotic medications in the United States, 1995-2008.
MedLine Citation:
PMID:  21218418     Owner:  NLM     Status:  Publisher    
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.
G C Alexander; S A Gallagher; A Mascola; R M Moloney; R S Stafford
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-1-6
Journal Detail:
Title:  Pharmacoepidemiology and drug safety     Volume:  -     ISSN:  1099-1557     ISO Abbreviation:  -     Publication Date:  2011 Jan 
Date Detail:
Created Date:  2011-1-10     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9208369     Medline TA:  Pharmacoepidemiol Drug Saf     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Department of Medicine, University of Chicago Hospitals, Chicago, Illinois.
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