Medications are said to be used “off-label” where the use is for the treatment of a disease for which the drug is not officially licensed, or in an unapproved age group, dosage, or route of administration.
Off-label use is generally legal unless it violates ethical guidelines or safety regulations. The ability to prescribe drugs for uses beyond the officially approved indications is commonly used to good effect by healthcare providers. For example, certain antidepressants such as fluoxetine, clomipramine and venlafaxine are commonly prescribed for the treatment of narcolepsy with cataplexy despite not being approved for use inthat condition.
Physicians in the United Kingdom can prescribe medications off-label. According to General Medical Council guidance, the physician must be satisfied that there is sufficient evidence or experience of using the medicine to demonstrate safety and efficacy. Prescribing off-label may be necessary when no suitably licensed medicine is available to meet the patient’s need.