An analysis of the high psychotropic off-label use in psychiatric disorders: The majority of psychiatric diagnoses have no approved drug

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Objective The authors’ goals were to determine the extent of unapproved indications in the DSM-IV-TR, to highlight common off-label uses of psychotropic medications and offer insights into the rationale of the widespread off-label prescribing in psychiatry. Method Indications for approved psychotropic agents, obtained from the Physicians Desk Reference and the Drug Information Handbook, Clinical Handbook of Psychotropic Drugs, 15th edition, and the Drugs@FDA online database were analyzed in the context of the DSM-IV-TR to determine the percent of DSM-IV-TR disorders that are indications for psychotropic agents. A literature search was performed to determine common off-label uses of major classes of psychotropic medications. Results 88.5% of all DSM-IV-TR categorized disorders lack an approved medication for their treatment. Atypical Antipsychotics had the most extensive off-label use for DSM-IV-TR categorized disorder, whereas Mood Stabilizers showed the greatest off-label use with regards to disorders and symptoms that are not DSM-IV classified. For each class of medications, more off-label uses exist than FDA-approved uses. Conclusions The vast majority of DSM-IV-TR categorized disorders lack approved medications for their treatment. The large unmet need for approved psychiatric indications may explain the widespread off-label use of psychotropic medications in clinical practice.