off-label


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off-label

(of-lā'bĕl),
Use of a licensed drug for an indication not approved by the F.D.A. or other governmental regulatory body.

off-label

(ôf′lā′bəl, ŏf′-)
adj.
Of or relating to a drug prescribed to treat a condition for which it has not been approved by the Food and Drug Administration.

Off-label

Referring to the use of a drug for a condition or disorder not listed in the official FDA labeling.
References in periodicals archive ?
05 ( ANI ): There have been concerns about off-label drug use causing vision loss in the patients.
Prescription drugs are licensed for certain conditions: off-label use means doctors are using them to treat illnesses outside of that designated or authorised list.
Doctors have instead been using hydroxychloroquine as an off-label alternative, but a study led by the University of Leeds found no benefit in taking hydroxychloroquine to control debilitating pain when compared to a placebo.
Although off-label prescribing is common, many consumers, physicians, and other medical professionals believe that unregulated off-label prescription is reckless and requires additional FDA oversight (Stafford 2008; Dresser and Frader 2009; Buppert 2012; Howard and Copland 2013).
Amoxicillin, approved as an antibiotic for adults, is often prescribed off-label to treat ear infections in children.
3) Since that time both the FDA and CMS have taken actions to warn industry that they wanted to reduce the adverse events associated with off-label use of blood glucose monitors, which were never tested or cleared by the FDA for use with critically ill patients.
And we know from experience that patients gain important benefits from some off-label uses while realizing no benefit or even harm from other off-label uses.
No systematic investigation of the off-label use of prescription drugs has been done to date, in part because physicians aren't required to document intended indications.
sales executive Fhtrick Fabian have become part of a growing crusade challenging the FDA's restrictions on the language used in off-label promotions.
The question concerning what drug makers should be allowed to convey about unapproved uses for their medicines has been widely debated ever since a federal appeals court three years ago overturned the criminal conviction of a sales rep for promoting so-called off-label uses of a drug.
It also raises an important issue--there's a difference between off-label communications and off-label marketing--and it's more than a finesse.