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off-label use

   Also found in: Dictionary/thesaurus, Acronyms, Wikipedia 0.01 sec.
Off-label use
A drug that is prescribed for uses, periods of time, or at dosages that are not FDA-approved.

off-label use
Unlabeled indication, unlabeled use Pharmacology The use of a drug–eg, tretinoin, an analog of vitamin A or medical device–eg, injectable collagen, to treat a condition for which it has not received approval by a regulatory agency–eg, the FDA; OLU is common in chemotherapy of difficult-to-treat cancers, for which there is no agreement on standardized therapy


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Marketing any drug for off-label uses is worthy of the highest rebuke, but this case is particularly unsettling because gabapentin, the active ingredient in Neurontin, has not been proven to be effective in treating bipolar disorder.
The proliferation of off-label uses constitutes powerful evidence against the argument that FDA regulation is necessary to prevent medical disasters because off-label uses are essentially unregulated by the FDA.
Off-label use may seem to safe, and clinicians may have observed that a specific drug seems to work for its off-label use.
 
 
 
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