off-label use

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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

Off-label use

A drug that is prescribed for uses, periods of time, or at dosages that are not FDA-approved.
References in periodicals archive ?
545, 560 (2014) ("FDA defers to physician discretion to prescribe off label, because it remains ignorant about safety and efficacy claims until they are proven.
Physicians are free to prescribe off label, and physicians, pharmacists, and anyone else can tout the off-label uses of a drug.
The discretion of doctors and other healthcare-team members who are licensed for prescribing drugs (pharmacists and specially trained and qualified nurses) to prescribe products off label is recognized.
1998), the court held that an FDA guidance restricting certain forms of manufacturer promotion of off label uses imposed unconstitutional restrictions on commercial speech under the First Amendment.
Although the decision was significant because of the First Amendment protection it extended to defendants facing allegations of off label marketing in certain instances, it was not clear whether it would actually affect the government's future prosecution of these cases.
Although Botox is approved in 70 countries around the world, including the United Kingdom, Canada, Brazil, Hong Kong, and recently Japan, to treat symptoms associated with juvenile cerebral palsy, it is currently off label in the United States.
Although physicians are permitted to prescribe off label, the FDA explains that, as a matter of good medical practice, physicians have a responsibility "to base [any off-label] use on finn scientific rationale and on sound medical evidence.
The most frequent off-label procedures were stent implantations, which were 99 percent off label, and balloon dilations, which were 78 percent off label.
W wants to know how he can minimize malpractice risk when prescribing a medication off label and wonders if citing an article in a patient's chart is a good or bad idea.
Although doctors may prescribe drugs off label, it is not permissible for drug companies to promote drugs for off-label uses.
Pediatricians frequently use medications off label.
Waxman, age 68, may be unwilling to take off label cardiac drugs, but millions of his fellow Americans have benefited from doing so.