Off-label use

Off-label use refers to the practice of prescribing pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs can be used in off-label ways, although most studies focus on the use of prescription drugs.

Overview

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 by healthcare providers worldwide to treat a wide range of conditions.

Regulation

In the United States, the Food and Drug Administration (FDA) is responsible for creating guidelines for the approval and use of drugs. However, healthcare providers are not required to follow these guidelines, and they are free to prescribe a drug for an off-label use. Off-label use is very common in pediatrics, psychiatry, and oncology.

Controversies

Off-label use of medications can often be very beneficial for patients. However, this practice has been criticized because it allows medications to bypass the FDA’s approval process for new uses. There have also been allegations of drug companies promoting off-label use of their drugs for financial gain.

See also

• Prescription drug
• Food and Drug Administration
• Pharmaceutical industry