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Off-label use

Synonym: off-label therapy
German: Off-Label-Use

1 Definition

Off-label use or off-label usage is the therapeutic application of drugs outside of the indicated areas or the group of persons that they are approved for by the regulatory medicines authority.

2 Background

Basically, every drug can be used off-label by the physician - however, he/she has to inform the patient more comprehensively, and he/she carries the liability risk for the therapy. Off-label prescriptions should only be carried out based on valid guidelines, generally recognized recommendations or scientific literature.

In many specialties, off-label use is medical daily routine - especially in pediatrics, since only few drugs are licensed for the use in children. A reason for that is that the clinical trials necessary for the licensing procedure are associated with high costs.

According to some authors, in the USA, up to 20% of all prescriptions could be classified as off-label use. [1]

see also: Compassionate use, unlicensed use

3 References

  1. Radley DC1, Finkelstein SN, Stafford RS: Off-label prescribing among office-based physicians. Arch Intern Med. 2006 May 8;166(9):1021-6.

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