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Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs. Off-label use is generally legal unless it violates ethical guidelines or safety regulations. It is commonly used to good effect by physicians, because they understand how to use it correctly. However, it can entail health risks and differences in legal liability. ==Frequency of off-label use== Off-label use is very common. Generic drugs generally have no sponsor as their indications and use expands, and incentives are limited to initiate new clinical trials to generate additional data for approval agencies to expand indications of proprietary drugs.〔 Up to one-fifth of all drugs are prescribed off-label and amongst psychiatric drugs, off-label use rises to 31%. Among use of antipsychotic medications in the United States, a shift occurred from typical agents in 1995 (84% of all antipsychotic visits) to atypical agents by 2008 (93%). Atypical use has grown far beyond substitution for the now infrequently used typical agents. A 2009 study found that 62% of U.S. pediatric office visits from 2001-2004 included off-label prescribing, with younger children at higher risk of receiving off-label prescriptions. Specialist physicians also prescribed off-label more frequently than general pediatricians. In 2003, passage of the Pediatric Research Equity Act gave the FDA power to require pharmaceutical companies to perform clinical trials in all age groups in which clinical use is reasonably foreseeable. By some estimates, the number of clinical trials performed in children from 2002 - 2012 exceeded that in the prior 50 years. In 2014, the American Academy of Pediatrics released a statement regarding off-label use of pharmaceuticals in children. The article recommends to pediatricians that "Off-label use is neither incorrect nor investigational if based on sound scientific evidence, expert medical judgment, or published literature" and that " Evidence, not label indication, remains the gold standard from which practitioners should draw when making therapeutic decisions for their patients." The statement further advocates additional support and additional incentives for clinical testing of drugs in children, and publication of all results irrespective of positive outcome. A study published in 2006 found that off-label use was the most common in anticonvulsant By default use of non-approved drugs is common in obstetrics as, by 2010, during almost five decades of activity the Food and Drug Administration (FDA) had approved only two drugs for obstetrical indications, namely oxytocin and dinoprostone.〔 A small market and the high risk of medicolegal action, as exemplified by the Bendectin case, may explain the reluctance to develop drugs for approval.〔 Some drugs are used more frequently off-label than for their original, 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. A 1997 survey of 200 cancer physicians by the American Enterprise Institute and the American Cancer Society found that 60% of them prescribed drugs off-label.〔(【引用サイトリンク】title=Why is off-label use of drugs so common in cancer treatment? )〕 In some cases, patients may perceive the efficacy of treatments for off-label purposes to be higher than for their indicated purpose. 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 antidepressants to treat neuropathic pain. This old class of antidepressants is now rarely used for clinical depression due to side effects, but the tricyclics are often effective for treating pain(.e.g. Neuropathy), as well as Attention deficit/hyperactivity disorder(ADHD) particularly in adults. 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Off-label use」の詳細全文を読む スポンサード リンク
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