Off-label use

Off-label use is the practice of prescribing drugsfor a purpose outside the scope of the drug's approved label, most often concerning the drug's indication. In the United States, the Food and Drug Administration(FDA) requires numerous clinical trials to prove a drug's safety and efficacy in treating a given disease or condition. If satisifed that the drug is safe and effective, the drug's manufacturer and the FDA agree on specific language describing dosage, route and other information to be included on the drug's label. More detail is included in the drug's package insert. However, once the FDA approves a drug for prescription use, they do not attempt to regulate the practice of medicine and so the physicianmakes decisions based on her or his best judgment. It is entirely legal in the United States and in many other countries to use drugs off-label. Exceptions to this are certain controlled substances, such as opiates, which cannot be legally prescribed except for approved purposes (at least in the U.S.).

Some drugs are used more frequently off-label than for their original, FDA-approved indications. A 1991 study by the U.S. General Accounting Office found that one-third of all drug administrations to cancer patients were off label and more than half of cancer patients received at least one drug for an off-label indication. Frequently the standard of care for a particular type or stage of cancer involves the off-label use of one or more drugs. An example is the use of tricyclic antidepressantsto treat neuropathicpain. This old class of antidepressantsis now rarely used for clinical depressiondue to side effects, but the tricyclics are often effective for treating pain.

Off-label use and the law

In the United States, FDA regulations permit physiciansto prescribe approved medications for other than their intended indications. Marketing information for the drug will list one or more indications, i.e., illnessesor medical conditions for which the drug has been shown to be both safe and effective. Pharmaceuticalcompaniesare 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, physiciansare free to prescribeit 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.

Off-label use of narcotics

While off-label administration of non-narcotic medications is generally tolerated by U.S. authorities, prescription of DEA schedulednarcoticsfor unapproved purposes is not. Medical licenserevocation, asset seizure, and incarcerationare all common consequences borne by doctors in violation of the prohibitionlaws.

Examples of off-label use

• Botulin toxinis approved for the treatment of muscle spasms. Under the tradename Botox, it has become the basis of a popular cosmetic anti-wrinkle procedure, which is much more economicallyimportant than the approved use.

• Carbamazepine, another anticonvulsant, has been used as a mood stabilizerand is accepted treatment for bipolar disorder.

• Methotrexate(MTX), approved for the treatment of choriocarcinoma, is frequently used for the medical treatment of an unruptured ectopicpregnancy. There is no FDA-approved drug for this purpose and no drug company would have any incentive to sponsor an unpatented drug such as MTX to get FDA-approval.

• The SSRImedication Zoloftis approved as an anti-depressant. It is also commonly prescribed off-label to help men suffering from Premature ejaculation.de:Off-Label Use

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It uses material from the http://en.wikipedia.org/wiki/Off-label+use Wikipedia article Off-label use.