Off-label
Off-label
Off-label (/ɒfˈleɪbəl/), also known as non-approved or unapproved use of a drug, 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 practice of labeling pharmaceuticals for specific uses approved by regulatory bodies such as the Food and Drug Administration (FDA) in the United States. When a drug is used in a way that is different from that described in the FDA-approved drug label, it is said to be used "off-label."
Related Terms
- Prescription drug: A pharmaceutical drug that legally requires a medical prescription to be dispensed.
- Over-the-counter drug: Drugs that can be sold directly to people without a prescription.
- Pharmacology: The branch of medicine that deals with the uses, effects, and modes of action of drugs.
- Clinical trial: Research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention.
- Adverse effect: An undesired harmful effect resulting from a medication or other intervention such as surgery.
Usage
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.
Risks
While off-label use often occurs based on evidence from clinical studies, there is a risk that patients may experience adverse effects or insufficient benefit due to the lack of rigorous testing for the new indication.
Regulation
Regulatory bodies like the FDA regulate the testing and approval of drugs, but not how doctors use drugs to treat their patients. However, in some cases, regulatory bodies may take action to limit or prohibit off-label use of certain drugs if safety issues arise.
External links
- Medical encyclopedia article on Off-label
- Wikipedia's article - Off-label
This WikiMD dictionary article is a stub. You can help make it a full article.
Languages: - East Asian
中文,
日本,
한국어,
South Asian
हिन्दी,
Urdu,
বাংলা,
తెలుగు,
தமிழ்,
ಕನ್ನಡ,
Southeast Asian
Indonesian,
Vietnamese,
Thai,
မြန်မာဘာသာ,
European
español,
Deutsch,
français,
русский,
português do Brasil,
Italian,
polski