title: Off-label use of antipsychotics: rethinking "off-label".
abstract: Antipsychotics are currently registered for the use in psychosis, mania and agitation. They have although been in common practice used for a wide range of psychiatric disorders even in the era of first generation antipsychotics. Such a use is termed "off-label". There are several drawbacks in off-label antipsychotics' prescribing among them legislative in case of complications, poorly defined criteria for their use (dosages, possible complications, time span), missing guidelines and treatment algorithms as well as missing consensus among clinicians about indications and treatment protocol. We have reviewed existing literature on the topic using Medline search for controlled and naturalistic data about off-label use of antipsychotics. The results have been combined with our descriptive clinical experiences as well as the process of making national recommendations on off-label use of antipsychotics. The results have shown that the practice of off-label use is widely accepted in clinical work not just for antipsychotics but for other psychotropic drugs in psychiatry as well. The level of evidence is however different and will be discussed. Indications for the use of antipsychotics are evolving with new generations, which is consistent with their mechanisms of action and anticipated from drug profiles of different newer antipsychotics. New official indications do show the dynamic properties of the term "off-label" which tends to be more a cross-sectional descriptive term rather then scientific fact. According to the evidence and practice antipsychotics are becoming antidepressants, anti-anxiety drugs, mood stabilizers, cognitive enhancers, anti-aggressive, anti-impulsive, anti-suicidal and hypnotic medications. We will propose a different way to classify the use of antipsychotics in indications different from those officially recognized.
authors.affiliation: University Psychiatric Hospital, Studenec 48, SI-1260, Ljubljana, Slovenia. urban.groleger@psih-klinika.si
authors.forename: Urban
authors.initials: U
authors.lastname: Groleger
mesh_terms: D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D001523:Mental Disorders / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents