Off-label use
Off-label use
Off-label use (/ɒfˈleɪbəl juːz/) refers to the practice of prescribing pharmaceuticals for an unapproved indication or in an unapproved age group, dosage, or route of administration.
Etymology
The term "off-label" is derived from the fact that this use is not listed on the drug's label, which is a document detailing the approved uses and doses, produced by the pharmaceutical company and approved by the Food and Drug Administration (FDA).
Definition
Off-label use is when a drug that's been approved by the Food and Drug Administration (FDA) for one purpose is used for a different purpose that hasn't been approved. However, a doctor can still use the drug for that purpose. This is because the FDA regulates the testing and approval of drugs, but not how doctors use drugs to treat their patients. So, your doctor can prescribe a drug however they think is best for your care.
Related Terms
- Prescription drugs: Medications that require a prescription by a healthcare professional.
- Food and Drug Administration (FDA): The federal agency responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs.
- Pharmaceutical company: A commercial business licensed to research, develop, market and/or distribute drugs, most commonly in the context of healthcare.
- Drug label: A piece of written, printed, or graphic matter upon the immediate container of any drug or medicine, officially recognized, and conforming to the requirements of the Food and Drug Administration.
External links
- Medical encyclopedia article on Off-label use
- Wikipedia's article - Off-label use
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