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| | Off-Label Uses of Prescription Drugs—An Overview |
 | | Off-label use of prescription drugs (also known as unlabeled, unapproved, or out-of-label use) refers to the practice of prescribing drugs or devices for uses not identified in the labeling of a drug. | | | Aspirin was used for years off label to reduce the incidence of heart attacks until its approval for this indication in 1998. | | | The practice of prescribing off label is a decision to be made by the treating health care practitioner based on data available on the drug and the clinical status of a patient. |
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http://www.pharmacytimes.com/article.cfm?ID=976
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| | OFF-LABEL USES OF APPROVED DRUGS |
| | For the past several years, the FDA has regulated as labeling nearly any statement by a manufacturer relating to an off-label use of a drug, regardless of the credibility or truthfulness of the statement, and without consideration of the promotional or descriptive nature of the announcement. | | | For the drug to be labeled for use in children, an NDA would have to be submitted with data establishing safety and effectiveness resulting from clinical studies using children as participants[39]. | | | Though the exact use to which such evidence can be put differs among jurisdictions[56], a physician is assured that under the current system, he will be given the opportunity to present a jury with the information that was used in assessing the treatment alternatives for the patient. |
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http://leda.law.harvard.edu/leda/data/130/rpritcha.html
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| | U.S. Pharmacist |
| | Institutional pharmacies and pharmacies that serve managed care plans with approved-use formularies should be especially cautious of marketing, persuasion, or coercion to use a drug for an off-label use in place of otherwise therapeutically equivalent drugs. | | | The off-label use of a drug should be based on sound scientific evidence, expert medical judgment, or published literature. | | | This decision is made on the basis of the information contained in the drug's label or other data available to the prescriber and pharmacist. |
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http://www.uspharmacist.com/index.asp?show=article&page=8_1078.htm
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| | Off-label use - Wikipedia, the free encyclopedia |
| | Off-label use is the practice of prescribing drugs for a purpose outside the scope of the drug's approved label, most often concerning the drug's indication. | | | An example is the use of tricyclic antidepressants to treat neuropathic pain. | | | However, once the FDA approves a drug for prescription use, they do not attempt to regulate the practice of medicine and so the physician makes decisions based on her or his best judgement. |
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http://en.wikipedia.org/wiki/Off-label
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| | Off-Label Uses of Prescription Drugs in Pain Management |
| | Dr. Kessler asked that I respond to your letter seeking clarification of FDA's position regarding the off-label use of FDA-approved drugs by physicians. | | | Labeling cannot provide full guidance on matters such as dosing, adverse effects, need for special monitoring, etc. for off-label uses. | | | Beneficial results have also been reported in glossopharyngeal neuralgia." The labeling warns of an association with aplastic anemia and agranulocytosis and goes on to say, "This drug is not a simple analgesic and should not be used for the relief of trivial aches or pains." |
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http://www.medsch.wisc.edu/painpolicy/publicat/95apsol.htm
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| | Bioethics: Off-Label Prescribing |
| | Miller stated that "the off-label use of a drug or device by a physician seeking an optimal treatment for his or her patient is not necessarily considered to be research or an investigational or experimental treatment when the use is customarily followed by physicians" (44 S.W.3d at 13, n.9). | | | From a legal and ethical standpoint, off-label use represents a delicate balance between the regulatory objective of protecting patients from unsafe or ineffective drugs and medical devices on the one hand, and, on the other hand, the prerogative of physicians to use their professional judgment in treating patients. | | | In some cases, off-label use might seem to be human experimentation: The physician has no hard evidence that the product is safe and efficacious for the intended use but, based on an educated guess, decides to try it and see. |
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http://www.thedoctorwillseeyounow.com/articles/bioethics/offlabel_11
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| | Why doctors prescribe off label |
| | Raymond Woosley, a University of Arizona expert in the pharmacology of heart drugs, agrees with Avorn that doctors can prescribe off label responsibly when strong published studies support a new use. | | | Off-label prescribing also is very common among cancer doctors, who are willing to accept the risks of unapproved treatments when their patients are running out of options. | | | Given a drug's painstaking path to approval in even a single disease, many Americans are surprised to learn what happens once a new medicine enters the U.S. market -- doctors are legally free to prescribe it off label for any other condition. |
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http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2005/05/01/MNG10CI3M71.DTL
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| | OFF-LABEL USES OF APPROVED DRUGS |
| | If a physician were to prescribe a drug for an off-label use to a patient who then purchased the drug in a new state or transported the drug to a new state. | | | For the drug to be labeled for use in children, an NDA would have to be submitted with data establishing safety and effectiveness resulting from clinical studies using children as participants[39]. | | | Though the exact use to which such evidence can be put differs among jurisdictions[56], a physician is assured that under the current system, he will be given the opportunity to present a jury with the information that was used in assessing the treatment alternatives for the patient. |
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http://leda.law.harvard.edu/leda/data/130/rpritcha.html
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| | DermatologyOffLabelUseArticle1198 |
| | We surveyed 55 dermatologists from a single large academic program to assess their use of particular drugs for specific skin conditions, their perception of such use as being for Food and Drug Administration-approved or for off-label indications, and their attitudes towards off-label therapies. | | | If a physician uses a drug for an off-label indication to benefit a patient while simultaneously using it as part of a research investigation, they are subject to appropriate internal review board and informed consent requirements. | | | Third, knowledge of mechanisms of action of drugs used in dermatology (eg, modulation of angiogenesis) is an important factor in the choice of therapy. |
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http://www.complemed.com/DermatologyOffLabelUseArticle1198.htm
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| | IRB Information Sheets--Off-Label and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices (Updated 9/98) |
| | If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects. | | | (i) it is not intended to be reported to FDA in support of a new indication for use or to support any other significant change in the labeling for the drug; | | | Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgement. |
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http://www.fda.gov/oc/ohrt/irbs/offlabel.html
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| | CHEST: Off label, on target? |
| | By its very nature though, off-label use represents extrapolation from prior experience and, more often than not, represents the early application of a yet-unproven therapy. | | | It refers to the use of a medication for a disease, or a dose, or method of administration that is not listed in the official labeling of its use. | | | This is demonstrated by the increasing use of hyperbaric oxygen therapy or noninvasive ventilation in a host of conditions similar but disparate from those in the initial investigations. |
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http://www.findarticles.com/p/articles/mi_m0984/is_4_126/ai_n7178975
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| | BrainTalk Communities - Off Label Use---Civil Rights Abuses |
| | In the end, the patient may be told or not depending by the doctor that the agent he wants to use is off label. | | | If an off label use harms anyone...you have the right to sue..and may make a good case. | | | I understand the intuitive appeal of the argument that it would be "worse" if someone was given a drug "off-label"--for a different condition than intended--and then things went awry. |
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http://brain.hastypastry.net/forums/showthread.php?goto=lastpost&t=82744
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| | LEGALISING OFF LABEL USE |
| | Off label use of drugs on patients either with their knowledge or even without is an unauthorized activity indulged in by a good number of medical practitioners in recent times in India and abroad. | | | After this and other reports, a section of medical practitioners backed by pharma companies has been approaching the office of Central Drug Control Standards Organization to make off label use of drugs a part of the Drugs and Cosmetics Rules. | | | A move is on to allow off label use of drugs by the medical practitioners under certain conditions. |
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http://www.pharmabiz.com/article/print.asp?articleid=25160
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| | Coming soon: off-label marketing, ACP Observer Dec 97 |
| | "One of the reasons why a large number of drugs that we keep off the market here get on the market in Europe is that they have lower standards there for drug approval," he said. | | | While many say that a streamlined drug approval process will benefit patients, the provision has some fierce critics. |
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http://www.acponline.org/journals/news/dec97/offlabel.htm
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| | Cytotec Induction and Off-Label Use - by Marsden Wagner, MD, MS |
| | Another problem with the excuse "we give drugs off-label all the time" is that the doctors using it are taking matters into their own hands when it comes to the use of drugs on their patients. | | | When obstetricians using Cytotec induction are confronted about their willingness to use a drug "off-label," they inevitably answer: "We use drugs off-label all the time." There are several serious problems with this answer. | | | Next, off-label use "is not considered experimental if based on sound scientific evidence." The whole purpose of on-label use is to guarantee the consumer that there is sound scientific evidence. |
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http://www.midwiferytoday.com/articles/cytotec.asp
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| | Understanding 'Off-Label' Drugs |
| | However, doctors may prescribe it to treat chronic pain - an off-label use. | | | This is called off-label use, which often means that the drug has been approved by the Food and Drug Administration (FDA) for a certain disease, but not for yours. | | | Off-label use is legal, so pharmaceutical companies don't have much reason to pursue the costly and long process of getting FDA approval. |
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http://www.adventisthealthcare.com/AHC/Atoz/hl/sp/home/alert02172005.asp
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| | Investigative Reporters and Editors, Inc. The IRE Journal: OFF-LABEL RX |
| | Such uses may strike consumers as odd, but for the medical community, they are an everyday thing: So-called "off-label" drug prescribing is an integral part of medicine, strongly defended by doctors. | | | Such uses are "off-label" because they're nowhere to be found on the official, FDA approved instructions - or label - for a drug. | | | Even so, we identified some lawsuits by using the full-text search feature on Nexis' "combined case law" database looking for the words "off-label" and "prescription." Unfortunately, most of these cases, because they were in the federal appeals process, were too old to use. |
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http://www.findarticles.com/p/articles/mi_qa3720/is_200403/ai_n9387117
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| | Off-Label Prescribing of Drugs Calls FDA Role into Question: Newsroom: The Independent Institute |
| | Since off-label prescriptions are not tied down by FDA-sanctioned uses, doctors and patients are free to experiment with medications to create a treatment more in tune with their personal preferences. | | | Through the use of off-label prescriptions, doctors successfully determine the efficacy of drugs on their own and build up a community of knowledge. | | | For example, when it was theorized that stomach ulcers were caused by bacteria, doctors tested this theory through the off-label prescription of antibiotics. |
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http://www.independent.org/tii/news/001125Esposito.html
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| | Off-Label Marketing of Pharmaceuticals |
| | Unapproved use should not be taken to mean disapproved use; however, the controversy surrounding off-label drug promotion has greatly complicated off-label prescribing and quality patient care. | | | There are three identified off-label practices: off-label use, off-label prescribing, and off-label marketing. | | | Off-label treatments sometimes constitute optimal patient care, and off-label prescribing is considered by law to be a legitimate part of the practice of medicine. |
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http://www.amsa.org/hp/OffLabel.cfm
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| | Annals of General Psychiatry Full text Off-label indications for atypical antipsychotics: A systematic review |
| | Although the recommendation to use atypical antipsychotics in a variety of off-label situations is widespread in the literature, the current review proved that data are few and can not really support an evidence based recommendation. | | | Also their use in the treatment of psychotic and behavioral disorders in the frame of dementia of various types may warrant further study. | | | On the contrary, the use of low-dose dopamine antagonists (e.g. |
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http://www.general-hospital-psychiatry.com/content/3/1/4
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| | HARD SELL / How Marketing Drives the Pharmaceutical Industry / A patient's right to know / How much should doctors disclose about treatments not approved by the FDA? |
| | Oden found out to her dismay that doctors continue to use the ulcer drug Cytotec off label to induce labor, in spite of a 2000 warning by the drugmaker that Cytotec could cause a pregnant woman's uterus to rupture. | | | Whether those patients who took it off label -- for ailments including migraine headaches, psychiatric illnesses and restless leg syndrome -- received any benefits while bearing Neurontin's risks is open to debate because the drug was never evaluated by the FDA for those uses. | | | Lawyers representing thousands of families in personal injury cases involving Neurontin, or anti-depressants such as Paxil, say none of their clients were told the drugs were given off label. |
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http://www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2005/05/01/MNG4TCID0J1.DTL
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| | Off-Label Uses of Prescription Drugs in Pain Management |
| | Department editors' note: The off-label use of prescription drugs is a topic of great interest in the field of pain management. | | | Consequently, we have used a variety of mechanisms over the past several years to encourage sponsors to expand the approved indications for their products to include off-label use where persuasive scientific evidence exists or can be developed to support new uses. | | | Off-label use of drugs to manage pain and other symptoms is common, is essential to effective medical management of patients with pain, and is supported by clinical experience, published literature, case law, and FDA policy statements. |
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http://www.medsch.wisc.edu/painpolicy/publicat/95apsol.htm
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| | Boston.com / Business / Medicare scrutinizing off-label uses for medicine |
| | Federal administrators who run the Medicare program have begun to closely scrutinize the off-label use of prescription drugs, using clinical reviews to determine which prescriptions will get into the hands of American consumers and which won't. | | | Off-label uses of drugs, meaning they are used in treatments not approved by the FDA, are common in US healthcare. | | | Meanwhile, the agency is considering revoking coverage for off-label uses for some cancer drugs, including Biogen Idec's Zevalin, an expensive treatment for non-Hodgkins lymphoma that is used off-label to treat other forms of cancer. |
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http://www.boston.com/business/globe/articles/2004/02/10/medicare_scrutinizing_off_label_uses_for_medicine
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| | The following Statement may apply: |
| | Any "off label" usage whether for topical, anti-bacterial, anti-parasitic, anti-fungal, and/or anti-viral purposes is solely the responsibility and choice of the user. | | | Such other activity as "off label" (usage of the product for purposes "not" found on the label) is not commented upon; with the exception of noting that for generations many MDs regularly participate in issuing "off label" Prescriptions/usage for a multiplicity/plethora of drug products. | | | It is known to be common practice in the Medical field. |
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http://www.silverproteinmild.com/Offlabel.html
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| | ACS :: Off-label passes muster |
| | "These proposed rules are intended to allow health-care practitioners to receive information about unapproved uses of approved medications and devices and to stimulate the development of new studies or collection of existing evidence about off-label uses for FDA's review," said Schultz. | | | "Off label" means that a physician uses a drug for one purpose that is approved by the FDA for another condition. | | | "Off label" means that a physician uses a drug for one purpose that is approved by the FDA for anoth... |
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http://www.cancer.org/docroot/NWS/content/NWS_1_1x_Off_label_passes_muster.asp
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| | IRB Information Sheets--Off-Label and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices (Updated 9/98) |
| | If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects. | | | Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgement. | | | Use of a marketed product in this manner when the intent is the "practice of medicine" does not require the submission of an Investigational New Drug Application (IND), Investigational Device Exemption (IDE) or review by an Institutional Review Board (IRB). |
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http://www.fda.gov/oc/ohrt/irbs/offlabel.html
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| | Why doctors prescribe off label |
| | Defenders of off-label use see it as a form of "innovative medicine'' that may make therapeutic advances available to patients when an FDA review isn't available. | | | "Bearing in mind that some off-label use is perfectly justifiable, it is fair to say that much of it is not justifiable,'' said Dr. Jerry Avorn, a pharmacology professor at Harvard Medical School and author of the book "Powerful Medicines," which calls for changes in prescribing patterns. | | | On the other hand, he said, some off-label drugs that soared into widespread use were later proved harmful by the kind of large-scale clinical trials the FDA requires for approval. |
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http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2005/05/01/MNG10CI3M71.DTL
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| | American Family Physician: Off-label use of prescription drugs - Editorial |
| | In the opinion of the treating physician who has detailed knowledge of the medical history and clinical status of a given patient, off-label drug use may be a reasonable choice for that specific patient in that setting. | | | It can be helpful to review the most recently updated FDA labeling for the drug, especially any black-box warnings, contraindications, drug-drug interactions, and side effects, especially as these might pertain to the proposed off-label use. | | | Off-label prescribing presents a challenge as well as an opportunity involving effectiveness and safety. |
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http://www.findarticles.com/p/articles/mi_m3225/is_3_68/ai_105929609
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| | Bioethics: Off-Label Prescribing |
| | Alvarez and other cases rejected this contention, often relying on an argument put forth by Beck and Azari in the article cited in the first paragraph of this Cyberounds®: "The bare fact of off-label use of a device or drug carries with it no medical information, either express or implied. | | | Second, the court made it clear that the fact that the drug was used off-label was not sufficient evidence by itself to prove that the physician was negligent.) | | | While patients might have some assurance that uses actually appearing on labeling are safe and effective, they cannot imply from a label's silence that a particular use recommended by their physician is unsafe, risky, novel, or untried" (Beck and Azari 1998, at 89). |
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http://www.thedoctorwillseeyounow.com/articles/bioethics/offlabel_11
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