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Home + Articles + Pharmacy Articles + Offlabel use

Offlabel use

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.

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