Off-label drug use
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Other Identifiers
- Work cat: United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on Human Resources and Intergovernmental Relations. Off-label drug use and FDA review of supplemental drug applications, 1998:p. 1 (off-label use of prescription medications; use of a drug for additional indications, additional patients, or at a different dosage level than originally approved; extra-label drug use; off-label use; off-label drug)
- MeSH, May 7, 2019(off-label use: the practice of prescribing or using a drug or a vaccine outside the scope of the drug's official approved label as designated by a regulatory agency concerning the treatment of a particular disease or condition; entry terms: dose-sparing drug use, fractional dose drug use, off-label prescribing, reduced-dose drug use, unlabeled indication; see also: drug approval, drug labeling, drug utilization)
- Merriam-Webster online, May 7, 2019(off-label; of, relating to, or being a drug used to treat a condition for which it has not been officially approved)
- The journal of law, medicine & ethics, Fall 2009:p. 476 (off-label prescribing; off-label use)
- Mayo Clinic. Mayo Clinic proceedings, Oct. 2012:p. 982 (off-label drug use; OLDU) p. 989 (practitioners are typically forced to use medications in an off-label manner to treat rare, or orphan, diseases; orphan drugs are often a subtype of OLDU)
Wikipedia description:
Off-label use is the use of 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 (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs. Off-label use is very common and 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, methotrexate is commonly used off-label because its immunomodulatory effects relieve various disorders. However, off-label use can entail health risks and differences in legal liability. Marketing of pharmaceuticals for off-label use is usually prohibited.
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