Definition of off-label in English:



  • Relating to the prescription of a drug for a condition other than that for which it has been officially approved.

    ‘the off-label use of potent antipsychotic medications’
    [as adverb] ‘children with severe anxiety disorders are given antidepressants off label’
    • ‘A physician is free to use a medical device for an off-label purpose, if, in the physician's medical judgment, he or she believes that use of the device will benefit the patient.’
    • ‘The drug's off-label users were mostly bodybuilders.’
    • ‘What protection do pregnant women have when it comes to the off-label use of obstetrical drugs?’
    • ‘This issue affects all doctors and off-label drugs will be needed more often for very ill children reflecting the higher usage in hospital.’
    • ‘In 1993, he was successful in a suit that forced the FDA to relax its rules prohibiting drug companies from promoting off-label prescribing.’
    • ‘Although off-label prescribing is legal, the US Food and Drug Administration prohibits drug companies from promoting such use to doctors.’
    • ‘In addition, the off-label use of any medical product comes with associated risks.’
    • ‘That these off-label indications were not measured in the approved trials must be made clear, however.’
    • ‘In British general practice, about a tenth of prescriptions for children are for off-label use of drugs.’
    • ‘The off-label use of capsaicin cream for treating painful scars is heretofore unreported.’
    • ‘That 40% of doctors prescribe off-label drugs does not surprise me.’
    • ‘Potentially fatal toxicities occur with off-label use of cancer drugs.’
    • ‘Current studies have not established safe and optimal dosages for either of these off-label uses.’
    • ‘It is a little absurd to blame animal safety data for hazards encountered from off-label prescribing.’
    • ‘Her doctor had prescribed Prozac off-label for an eating disorder.’
    • ‘In the United States once a drug is approved doctors who are willing to do so can prescribe it for off-label uses.’
    • ‘Though these uses aren't approved by the FDA, doctors can prescribe thalidomide for other indications, sometimes called off-label uses.’
    • ‘A study in Holland found almost one in four prescriptions for children were for drugs that are not licensed for use on children or that are prescribed off-label - outside the terms of the licence.’
    • ‘Knight Ridder identified more than 800 reports filed during 2002 of serious reactions involving off-label prescriptions for its sample of 45 drugs.’
    • ‘It states: ‘Hospital trusts in the UK are advising clinicians not to prescribe off-label drugs for palliation, so clinicians find themselves in an untenable position.’’