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Topic: Offlabel use

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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.
		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 judgment.
		Methotrexate (MTX), approved for the treatment of choriocarcinoma, is frequently used for the medical treatment of an unruptured ectopic pregnancy.
	en.wikipedia.org /wiki/Offlabel_use (784 words)

	Off-Label Drug Facts
		Off-Label Drug Facts is a NEW loose-leaf publication detailing current off-label drug use not reflected in FDA-approved labeling.
		Organized in tabular format, all relevant placebo-controlled and non-controlled trials are summarized, as well as historical cohort studies and case reports for each unlabeled use.
		A summary of studies including therapeutic considerations is provided for each off-label use.
	www.ramex.com /fc/fc-11522.html (220 words)

	AMA (CSAPH) Report 8 of the Council on Scientific Affairs (A-02) Full Text
		Clinical use was facilitated by the fact that the drug is relatively inexpensive compared with other regimens, and is stable at room temperature.
		Several recent reviews have been published that have examined both the intravaginal and oral use of misoprostol and that support the safe and effective off-label use of misoprostol for cervical ripening, evacuation of the uterus in cases of embryonic or fetal death, and induction of labor.
		Resolution 514 was submitted because clinical use of misoprostol for off-label indications had been hampered by the product labeling which specified that misoprostol was contraindicated, because of its abortifacient property, in women who are pregnant.
	www.ama-assn.org /ama/pub/category/13650.html (699 words)

	Off-Label Use of Prescription Drugs (CBM 92-11)
		OFF-LABEL USE OF PRESCRIPTION DRUGS Since the early 1960s, the Food and Drug Administration (FDA) has required that drugs used in the United States be both safe and effective.
		The use of a drug for a disease not listed on the label, or in a dose or by a route not listed on the label, is considered to be a "nonapproved" or "unlabel" or "off-label" use of the drug.
		Physicians, based on their knowledge and on available current information, may use a drug for a use not indicated in the "approved" labeling if it seems reasonable or appropriate.
	permanent.access.gpo.gov /lps20260/www.nlm.nih.gov/pubs/cbm/offlabel.html (1726 words)

	Healthy Skepticism library reference details
		Since the FDA has a reputation for having a low threshold for approving new indications for drugs, on the slightest whiff of a chance that they may be useful, any off-label use is likely to have a high probability of doing more harm than good.
		The new study used data from the 2001 IMS Health National Disease and Therapeutic Index to define prescribing patterns for 160 commonly prescribed drugs, representing slightly more than half of all prescriptions collected by IMS Health, which provides prescription market data for drug and biotech companies.
		In some cases, Stafford notes, scientific evidence for off-label use is strong, but, because the drug is generic, no maker stands to profit by pursuing FDA approval for a new use.
	www.healthyskepticism.org /library/ref.php?id=5119 (680 words)

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	e-docs.bea.com /wls/docs90/wlstaglibdoc/wl-extension/checkbox.html (292 words)

	Off-label Prescribing Among Office-Based Physicians - CISAC
		Outcome measures included (1) the proportion of uses that were off-label and (2) the proportion of off-label uses supported by strong scientific evidence.
		Multivariate analyses were used to identify drug-specific characteristics predictive of increased off-label use.
		Off-label use was most common among cardiac medications (46%, excluding antihyperlipidemic and antihypertensive agents) and anticonvulsants (46%), whereas gabapentin (83%) and amitriptyline hydrochloride (81%) had the greatest proportion of off-label use among specific medications.
	cisac.stanford.edu /publications/offlabel_prescribing_among_officebased_physicians (270 words)

	Extralabel Drugs Prescribed by Veterinarians
		'Extra-label drug use' describes the veterinary use of a drug in a manner for which it was not approved.
		Extra-label drug use occurs when a drug only approved for human use is used in animals, when a drug approved for one species of animal is used in another, or when a drug is used to treat a condition for which it was not approved.
		Veterinarians have the ability to use drugs in an extra-label manner as a result of the Animal Medicinal Drug Use Clarification Act which became effective in December 1996.
	www.peteducation.com /article.cfm?cls=0&cat=1303&articleid=1412 (158 words)

	Information about the off-label use of prescription drugs
		Thus, from this brief inspection it would appear worthwhile to evaluate the commercial potential of using ketoprofen in combination with peginterferon/interferon for the treatment of patients with chronic hepatitis C. Ketoprofen remains the most studied NSAID for this condition.
		Although beyond the scope of the present illustration, use of one of the above agents would provide the basis of a novel therapy designed to attenuate in some part the psychiatric adverse effects in interferon-alfa-treated patients with chronic hepatitis C without attenuating the efficacy of ketoprofen to enhance the antiviral efficacy of interferon-alfa.
		Following an extensive review of the literature these workers observed that the use of selective serotonin reuptake inhibitors (SSRIs) for the treatment of neuropsychiatric side effects associated with the use of interferon-alfa increased the risk of gastrointestinal haemorrhage in patients with chronic hepatitis C already receiving an NSAID.
	www.off-label.com /ConsultancyUK.cfm (1284 words)

	PJ Online \| News: Off-label prescribing for children is common
		In the first study, German researchers found that among 1,592,006 prescriptions for a group of children in primary care, 13.2 per cent were off-label.
		The proportion of off-label prescriptions was highest for 1—2 year olds and was common for cardiovascular drugs, drugs used for genitourinary disorders and anti-inflammatory agents.
		In the final study, researchers, also from the Netherlands, calculated that the overall risk for children receiving an unlicensed or off-label drug was 13.9 per cent per consultation.
	www.pharmj.com /editorial/20020601/news/offlabel.html (212 words)

	KentuckyDems.com - Kentucky Democrats Making a Difference
		Although it may be appropriate for physicians to prescribe drugs for offlabel uses, it is illegal for pharmaceutical manufacturers to promote the offlabel use of their drugs.
		This offlabel marketing campaign, aimed at tainting the information stream to physicians, and ultimately consumers, resulted in inappropriate, unnecessary and/or ineffective prescriptions for Neurontin which was paid for by the Medicaid program.
		Approximately 90% of Neurontin usage is for offlabel purposes.
	www.kentuckydems.com /index.php?option=content&task=view&id=80&Itemid=31 (1528 words)

	HMSA.com - 50 Plus (Site not responding. Last check: 2007-10-21)
		Written protocol or protocols used by the treating facility or the protocol(s) of another facility studying substantially the same drug, device, medical treatment or procedure; or
		Written informed consent used by the treating facility or by another facility studying substantially the same drug, device, medical treatment or procedure.
		HMSA is licensed to use the Blue Cross and Blue Shield symbols in the state of Hawaii.
	www.hmsa.com /seniors/50plus/benefits/experiment.asp (238 words)

	Re: Consider This 10.11
		A second site was www.fda.gov/fdac/departs/1999/599_irs.html which was interesting from the point that it was an article from their consumer magazine about the FDA criminally prosecuting a company for actively promoting an off-label use which is against FDA policy.
		I feel that it is very strong that they need to not have the manufacturers promote unapproved uses, but I also believe that doctors do need some latitude to be able to provide products that may not fully meet the “approved” uses.
		Otherwise, if a doctor deviates slightly from an approved use (say even giving a dosage to a 17 year old when something has only been tested on an “adult”) may bring criminal prosecution against doctors which could become very devastating.
	virtual.yosemite.cc.ca.us /makil/_grp4/0000008c.htm (322 words)

	CNN - Consumer group objects to 'off-label' drug promotion - June 25, 1998
		It is already legal for doctors to prescribe drugs for unapproved purposes, called "off-label" uses.
		A new law changes that, and the U.S. Food and Drug Administration is proposing new rules that will implement the law.
		The FDA's new rules would allow the companies to promote off-label uses while placing restrictions on the kind of information distributed in the process.
	www.cnn.com /HEALTH/9806/25/drug.alternatives (326 words)

	Coming soon: off-label marketing, ACP Observer Dec 97
		With off-label drug use, drug companies will not be allowed to buy ads promoting off-label uses of their drugs, but they will be allowed to distribute reprints of articles from peer-reviewed journals or medical textbooks discussing successful uses of a product that have not been subject to full-scale FDA review and approval.
		If the use is off-label, then by definition it is unapproved by the FDA, which is charged with protecting the public from unsafe drugs, medical devices and foods.
		First, the FDA will be allowed to approve drugs for use in the United States based on a lower level of evidence than had previously been allowed.
	www.acponline.org /journals/news/dec97/offlabel.htm (1746 words)

	CNN - FDA proposes new rules making 'off-label' drug use easier - June 5, 1998
		Under the current system, once a drug or device is approved by the FDA for any use, physicians can prescribe or use them for other ailments or procedures in what is called "off- label" use.
		Drugs approved to treat one form of cancer, for instance, are often used for other types of cancer, and a cancer drug known as hydroxyurea is sometimes used to treat sickle-cell anemia and HIV infection.
		The FDA now requires companies to prove a proposed new drug or device is safe and actually works for the specific disease or condition for which it is being licensed.
	www.cnn.com /HEALTH/9806/05/fda.off.label/index.html (415 words)

	IRB Information Sheets--Off-Label and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices (Updated ...
		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.
		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.
		When the principal intent of the investigational use of a test article is to develop information about the product's safety or efficacy, submission of an IND or IDE may be required.
	www.fda.gov /oc/ohrt/irbs/offlabel.html (430 words)

	[No title] (Site not responding. Last check: 2007-10-21)
		The appropriateness of these variations may depend on the ability of the implant program to evaluate and follow the children they see, such that all children who are implanted are able to attain their full potential.
		Often, a baby who displays no responses to even the loudest sounds initially will begin to respond to some sounds after a period of hearing aid use, especially when he or she is receiving frequent services through an auditorybased early intervention program.
		It is always essential that the teachers and therapists working with the child understand the appropriate therapeutic steps in cochlear implant habilitation; for instance, articulation therapy is not productive with a child who is just learning to accurately detect the presence or absence of sound or to distinguish patterns.
	www.sjsu.edu /upload/course/course_1300/CI___House_Candidacy.doc (2534 words)

	Pharmaceutical Pharmaceutics Pharmaceutical Drugs Online Indian Pharmaceutical Research Pharmaceutical Consulting
		One example of off-label use is the use of Tegretol (Carbamazepine), an anticonvulsant.
		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.
	www.livemedinfo.com /Offlabel-use.htm (285 words)

	1997.07.08 : Health Advisory On Fenfluramine/Phentermine for Obesity (Site not responding. Last check: 2007-10-21)
		Recently, however, they have been widely used "offlabel" in combination and for longterm management of obesity.
		Researchers at the Mayo Clinic and Mayo Foundation, Rochester, Minn., today also announced results of a study of valvular disease in women who took the combination of fenfluramine and phentermine for management of obesity, to be published in the N ew England Journal of Medicine next month.
		There is no conclusive evidence of a causeeffect relationship between use of the drugs and the development of valvular disease.
	www.hhs.gov /news/press/1997pres/970708.html (397 words)

	Medications widely prescribed for unproven treatments
		It is unclear how off-label uses become established within the medical community in cases where limited or no scientific evidence backs up their use.
		Other off-label use may represent an extension of labeled uses or evolving new uses that have not been evaluated stringently.
		Stafford said better communication and education for both the physician and patient about off-label use is crucial to good health care.
	news-service.stanford.edu /news/2006/may10/med-offlabel-051006.html (922 words)

	Off-Label Marketing of Pharmaceuticals
		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.
		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.
		Other use or reproduction of these materials requires written authorization from the American Medical Student Association.
	www.amsa.org /hp/OffLabel.cfm (464 words)

	SF AIDS Fdn: BETA Winter 2002 -- Peripheral Neuropathy
		Because treatment of HIV/AIDS-related neuropathic pain is an “offlabel” use for existing drugs (that is, a use other than that for which the drug was approved), insurance companies may deny coverage.
		McArthur notes that the subjective pain scales used in many PN clinical trials may not be a good measure of how well a drug works, since they may be too imprecise to measure small treatment effects.
		Plasmapheresis and IVIG are not useful for DSP.
	www.sfaf.org /treatment/beta/b49/b49neuropathy.html (5314 words)

	U.S. Newswire : Release : Eli Lilly and Company to Pay U.S. $36 Million Relating to OffLabel Promotion (Site not responding. Last check: 2007-10-21)
		Evista is approved by the FDA for the prevention and treatment of osteoporosis in post-menopausal women.
		Potential problems that can arise from off-label use without the benefit of careful FDA oversight include the possibility that the promoted drug was used instead of another drug that had already been approved by the FDA for a particular use.
		By measuring and analyzing incremental new prescriptions for doctors who attended the advisory board meetings, Lilly was using this intervention as a tool to promote and sell Evista.
	releases.usnewswire.com /printing.asp?id=58497 (1270 words)

	Is AMDUCA enough? - February 15, 2003
		As a result of this single disciplinary case, the Texas state board in November 2002 implemented a rule requiring veterinarians to inform clients of extralabel drug uses that are not commonly accepted or used in the veterinary community.
		New rule 573.45 in the Texas administrative code, "Extra-Label or Off-Label Use of Drugs," defines extralabel or offlabel use, lists what a veterinarian should consider in exercising discretionary usage, and attempts to identify the circumstances that require informed consent.
		This makes extralabel use of human drugs, within a standard of practice, a common necessity for veterinarians.
	www.avma.org /onlnews/javma/feb03/030215k.asp (892 words)

	Fogarty - Research Ethics Website
		The use of an FDA-approved drug is considered investigational when (a) its use is different from the FDA-approved use and (b) it poses an increased risk.
		If you plan in your human subjects study to use an FDA approved drug, but you propose an "off-label" or investigational use of the product, then you will need to file an IND.
		If you plan in your human subjects study to use a product (including a shelf-chemical) that does not have FDA approval, then you should file an IND application.
	bms.brown.edu /fogarty/fda.htm (464 words)

	APO (Site not responding. Last check: 2007-10-21)
		Oncologists consistently report that offlabel use of anti-cancer therapies is essential in helping patients with rare and advanced cancers, according to the study, which was commissioned by Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO) and the Association of Community Cancer Centers (ACCC).
		Fifteen of 28 oncologists interviewed reported that Medicare non-coverage frequently or very frequently causes them to alter their treatment decisions, while eight reported that private payer policies have this effect.
		Findings revealed that nearly 70 percent of oncologists interviewed think off-label use of cancer treatments is important in optimizing the overall treatment plans for their patients.
	www.americanpharmaceuticaloutsourcing.com /industryNewsArticle.aspx?article=233 (367 words)

	RedOrbit NEWS \| Turning Over a New Leaf Versus Shaking the Tree (Site not responding. Last check: 2007-10-21)
		Last, pharmaceutical suppliers are promoting "offlabel" uses for their drugs, particularly for problems that have no solution.
		Look at your workplace and become aware of the drugs you are promoting when you use the pen or write on the paper that has a drug name on it.
		Care must be taken as well to avoid the "off- label" uses, because this puts our licenses in jeopardy.
	www.redorbit.com /modules/news/tools.php?tool=print&id=95581 (587 words)

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