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Off-label use is the use of a prescription drug by a doctor
to treat a condition that has not been governmentally approved.
Offlabel use and the law
In the United States, the regulations of the Food and Drug
Administration (FDA) permit physicians to prescribe approved
medications for other than their intended indications. Marketing
information for the drug will list one or more indications,
i.e., illnesses or medical conditions for which the drug has
been shown to be both safe and effective. Pharmaceutical companies
are not allowed to promote a drug for any other purpose without
formal FDA approval.
However, once a drug has been approved for sale for one purpose,
physicians are free to prescribe it for any other purpose that
in their professional judgment is both safe and effective; they
are not limited to its official, FDA-approved indications. This
off-label prescribing is most commonly done with older, generic
medications that have found new uses but have not had the formal
(and often costly) applications and studies required by the
FDA to formally approve the drug for these new indications.
However, there is usually extensive medical literature to support
the off-label use.
Examples of offlabel use
One example of off-label use is the use of Tegretol (Carbamazepine),
an anticonvulsant. This medication has been used as a mood stabilizer
and is accepted treatment for bipolar disorder.
Some drugs are used much more off-label than for their original,
FDA-approved indications. A good example is the use of tricyclic
antidepressants for neuropathic pain. This is an older class
of antidepressants that is now rarely used on clinical depression
because of side effects, but which are usually more effective
on pain than the newer SSRI class of antidepressants.