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 ?
2, 2015 /PRNewswire-USNewswire/ -- State long term care leaders today launched theOne a Month campaign aimed to build on recent success in lowering the use of off label antipsychotics in the treatment of some Texas nursing home residents.
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.
A few years ago, after some hearings, the FDA decided that companies couldn't promote off-label uses, but if doctors ask [pharmaceutical salespeople] about off-label uses or want to see any articles in the literature about off-label uses, it's OK for drug companies to make those articles available and to allow their representatives to talk about those off label uses.
As for Ivomec, it is given off label to alpacas worth millions of dollars combined every month.
Other anabolics that had also been used off label in AIDS have been discontinued -- and then later come back with an HIV label (FDA approval for the HIV use), but with a huge price increase, typically more than 10 times their former cost.
In summary, off-label prescribing is common in every field of medicine, and in a large number of fields most patients are prescribed at least one drug off label.
com) announces updates to their Off Label database.
The first False Claims Act case involving off label marketing of a drug (Neurontin) was filed in 1996.
has agreed to pay more Indian $425 million to settle claims that it inappropriately marketed three drugs for off label uses, according to the U.
Critics cite as proof of the existing policy's shortcomings the numerous cases in which patients have been injured by products used off label.
Up to 50 percent of prescriptions written are for off label treatments.
The study can't tell us why doctors prescribe drugs off label.