Harvard Mental Health Letter

In Brief: Off-label drug use

In Brief

Off-label drug use

A study of Medicaid recipients in Georgia shows that antidepressants, anticonvulsants, and antipsychotic drugs are widely prescribed off-label — that is, in the treatment of disorders for which they do not have FDA approval.

The analysis indicates that in the year 2001, 75% of adult Medicaid patients receiving antidepressants, 80% of those receiving anticonvulsants, and 64% of those receiving antipsychotic drugs were given at least one prescription for these medications off-label. The proportion of off-label prescriptions was especially high for the anticonvulsant gabapentin (98%), the antidepressant amitriptyline (81%), and the sleeping pill and anti-anxiety drug lorazepam (89%).

Patients with major depression were commonly given anticonvulsant and antipsychotic drugs off-label. Patients with mental retardation, psychotic symptoms, Alzheimer's disease, and other neurological disorders were most likely to receive antipsychotic drugs (approved chiefly for schizophrenia) off-label. Kidney failure was the only disease that led to a high rate of off-label prescription for all three classes of psychiatric drugs.

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