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Off-label Use (off-label + use)

Distribution by Scientific Domains

Medical Sciences	94%

Distribution within Medical Sciences

Cardiovascular Disease	24%
Dermatology	11%

Selected Abstracts

Pediatric Interventional Cardiology in the United States is Dependent on the Off-label Use of Medical Devices

CONGENITAL HEART DISEASE, Issue 1 2010
Jamie S. Sutherell MD
ABSTRACT Objective., A substantial unmet medical device need exists in pediatric care. As a result, the off-label use of approved devices is routine in pediatric interventional cardiology, but the extent and nature of this practice has not been previously described. The purpose of this study, therefore, is to evaluate the prevalence and nature of off-label cardiac device use in an active pediatric interventional program in the United States. Study Design., This study is a retrospective review of all interventional cardiac procedures performed at our institution from July 1, 2005 to June 30, 2008. Diagnostic (noninterventional) catheterizations, myocardial biopsies, invasive electrophysiology studies, and studies involving investigational devices were excluded. Interventions performed were compared with the manufacturer's labeled indications for each device. Results., During this 3-year period, 473 patients (median age 4.1 years) underwent 595 transcatheter interventions. An approved device was utilized for an off-label application in 63% of patients, and in 50% of all interventions performed. The most frequent off-label procedures were stent implantations (99% off-label), balloon dilations (78% off-label), and coil embolizations (29% off-label). In contrast, the off-label use of septal and ductal occluders was relatively uncommon. Conclusions., In our routine (noninvestigational) practice of pediatric interventional cardiology, 63% of patients underwent procedures utilizing medical devices for off-label indications. These data underscore the need to enhance cardiac device review and approval processes in the United States to include pediatric applications. [source]

Mirtazapine: only for depression?

ACTA NEUROPSYCHIATRICA, Issue 3-4 2006
Luis San
Background:, Mirtazapine is an antidepressant first approved in the Netherlands in 1994 for the treatment of major depressive disorder. However, evidence suggests its effectiveness in a variety of other psychiatric disorders and non-psychiatric medical conditions. Objective:, The present paper reviews the published literature on the off-label indications of Mirtazapine. Methods:, A search of the relevant literature from MEDLINE, PsycLIT and EMBASE databases, included in the Science Citation Index and available up to March 2006, was conducted using the terms mirtazapine, case-reports, open-label trials and randomized controlled trials. Only articles referring to conditions other than major depression were included in this present review. Results:, Off-label use of mirtazapine has been reported in panic disorder, post-traumatic stress disorder, generalized anxiety disorder, social phobia, obsessive-compulsive disorder, dysthymia, menopausal depression, poststroke depression, depression as a result of infection with human immunodeficiency virus, elderly depression, Methylenedioxymethamphetamine (MDMA)-induced depression, hot flashes, alcohol and other substance use disorders, sleep disorders, sexual disorders, tension-type headaches, cancer pain, fibromyalgia, schizophrenia and other less frequent conditions. Conclusions:, So far, data on the off-label usefulness of mirtazapine are limited and mainly based on observations from case reports or open-label studies. However, positive cues suggest that confirmation of these preliminary data with randomized controlled trials may give sufficient evidence to warrant the use of mirtazapine in a broad range of disorders. [source]

Temporal Trends in the Use of Drug-eluting Stents for Approved and Off-label Indications: A Longitudinal Analysis of a Large Multicenter Percutaneous Coronary Intervention Registry

CLINICAL CARDIOLOGY, Issue 2 2010
Sarah K. Gualano MD
Background We sought to examine the temporal variations in the rate of both bare-metal stent (BMS) and drug-eluting stent (DES) use for off-label indications after the reports of an increased risk of very late stent thrombosis in patients with DES at the 2006 meeting of the European Society of Cardiology (ESC). Hypothesis To determine whether the decrease in use of DES has affected both on and off-label indications. Methods The study cohort included patients undergoing coronary intervention in a large regional registry, the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2). Patient demographic and clinical characteristics for patients with DES in the third quarter of 2006 (pre-ESC) were compared to those from the fourth quarter of 2008 (post-guideline changes). Use of DES for off-label indications, such as ST-segment elevation myocardial infarction (STEMI), in-stent restenosis (ISR), and saphenous vein graft (SVG) interventions, were evaluated. Results The overall deployment of DES fell sharply from 83% pre-ESC to a plateau of 58% in the first quarter of 2008. This corresponded to a rise in BMS use, while angioplasty procedures stayed the same. The STEMI subgroup showed the most dramatic change, from 78% to only 36%. Off-label use in SVGs showed a similar trend, from 74% to 43%. Drug-eluting stent deployment for ISR was less affected, though it also fell 25% (from 79%,56%). Conclusions The use of DES has fallen dramatically from June 2006 to December 2008, particularly for nonapproved indications. Our study provides a real-world assessment of contemporary change in DES use in response to the presentation of negative observational studies. Copyright © 2010 Wiley Periodicals, Inc. [source]

Pediatric Interventional Cardiology in the United States is Dependent on the Off-label Use of Medical Devices

Injecting 1000 Centistoke Liquid Silicone With Ease and Precision

DERMATOLOGIC SURGERY, Issue 3 2003
Anthony V. Benedetto DO, FACP
BACKGROUND Since the Food and Drug Administration approved the use of the 1000 centistoke liquid silicone, Silikon 1000, for intraocular injection, the off-label use of this injectable silicone oil as a permanent soft-tissue filler for facial rejuvenation has increased in the United States. Injecting liquid silicone by the microdroplet technique is the most important preventive measure that one can use to avoid the adverse sequelae of silicone migration and granuloma formation, especially when injecting silicone to improve small facial defects resulting from acne scars, surgical procedures, or photoaging. OBJECTIVE To introduce an easy method for injecting a viscous silicone oil by the microdroplet technique, using an inexpensive syringe and needle that currently is available from distributors of medical supplies in the United States. METHOD We suggest the use of a Becton Dickinson 3/10 cc insulin U-100 syringe to inject Silikon 1000. This syringe contains up to 0.3 mL of fluid, and its barrel is clearly marked with an easy-to-read scale of large cross-hatches. Each cross-hatch marking represents either a unit value of 0.01 mL or a half-unit value of 0.005 mL of fluid, which is the approximate volume preferred when injecting liquid silicone into facial defects. Because not enough negative pressure can be generated in this needle and syringe to draw up the viscous silicone oil, we describe a convenient and easy method for filling this 3/10 cc diabetic syringe with Silikon 1000. RESULTS We have found that by using the Becton Dickinson 3/10 cc insulin U-100 syringe, our technique of injecting minute amounts of Silikon 1000 is facilitated because each widely spaced cross-hatch on the side of the syringe barrel is easy to read and measures exact amounts of the silicone oil. These lines of the scale on the syringe barrel are so large and clearly marked that it is virtually impossible to overinject the most minute amount of silicone. CONCLUSION Sequential microdroplets of 0.01 cc or less of Silikon 1000 can be measured and injected with the greatest ease and precision so that inadvertent overdosing and complications can be avoided. [source]

The abuse potential of the synthetic cannabinoid nabilone

ADDICTION, Issue 3 2010
Mark A. Ware
ABSTRACT Aim Nabilone is a synthetic cannabinoid prescription drug approved in Canada since 1981 to treat chemotherapy-induced nausea and vomiting. In recent years, off-label use of nabilone for chronic pain management has increased, and physicians have begun to express concerns about nabilone becoming a drug of abuse. This study evaluates the evidence for abuse of nabilone, which is currently ill-defined. Study design Scientific literature, popular press and internet databases were searched extensively for evidence of nabilone abuse. Focused interviews with medical professionals and law enforcement agencies across Canada were also conducted. Findings The scientific literature and popular press reviews found very little reference to nabilone abuse. Nabilone is perceived to produce more undesirable side effects, to have a longer onset of action and to be more expensive than smoked cannabis. The internet review revealed rare and isolated instances of recreational use of nabilone. The database review yielded little evidence of nabilone abuse, although nabilone seizures and thefts have occurred in Canada in the past few years, especially in Ontario. Most law enforcement officers reported no instances of nabilone abuse or diversion, and the drug has no known street value. Medical professionals reported that nabilone is not perceived to be a matter of concern with respect to its abuse potential. Conclusions Reports of nabilone abuse are extremely rare. However, follow-up of patients using nabilone for therapeutic purposes is prudent and should include assessment of tolerance and dependence. Prospective studies are also needed to definitively address the issue of nabilone abuse. [source]

Results, Rhetoric, and Randomized Trials: The Case of Donepezil

JOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 8 2008
John R. Gilstad MD
Whether donepezil provides meaningful benefit to patients with Alzheimer's disease (AD) is controversial, but drug sales annually total billions of dollars. A review of data from published randomized clinical trials (RCTs) found rhetorical patterns that may encourage use of this drug. To create a reproducible observation, the sentences occurring at five specific text sites in all 18 RCTs of donepezil for AD were tabulated, as were study design, sources of financial support, and outcomes that could be compared between trials. Rhetoric in the 13 vendor-supported trials (15 publications) was strongly positive. Three early trials used the motif "efficacious (or effective) , treating , symptoms" four times. "Well-tolerated and efficacious" or an equivalent motif appeared 11 times in five RCTs. Nine RCTs referred 15 times to previously proven effectiveness. Seven trials encourage off-label use, for "early" cognitive impairment, severe dementia in advance of the Food and Drug Administration labeling change, or behavioral symptoms. These rhetorical motifs and themes appeared only in the vendor-supported trials. Trials without vendor support described the drug's effects as "small" or absent; two emphasized the need for better treatments. RCT results were highly consistent in all trials; the small differences do not explain differences in rhetoric. At these text sites in the primary research literature on donepezil for AD, uniformly positive rhetoric is present in all vendor-supported RCTs. Reference to the limited benefit of donepezil is confined to RCTs without vendor support. Data in the trials are highly consistent. This observation generates the hypothesis that rhetoric in vendor-supported published RCTs may promote vendors' products. [source]

Hand recontouring with calcium hydroxylapatite (Radiesse)®

JOURNAL OF COSMETIC DERMATOLOGY, Issue 1 2009
FAACS, Kenneth L Edelson MD
Summary The aging hand is a common area of concern for many patients. Until recently, adequate treatment options have been hampered by pain of injecting into the dorsum and, post-injection, by the absence of longevity of treatment. In this article, we describe the off-label use of the soft tissue filler calcium hydroxylapatite (CaHA; Radiesse) for hand rejuvenation. The product is inherently biocompatible and, when placed in soft tissue, induces neocollagenesis. An alternative injection mixture of CaHA combined with lidocaine is described, as well as the novel "bolus" injection technique. The CaHA-lidocaine emulsion reduces the pain of injection to nearly none at all, improves the rheology of the procedure, and allows for deposition of the product into the correct plane of tissue. The volume of CaHA injected as well as the amount of lidocaine used for the mixture vary according to physician preference. In our practice, 1.3 mL of CaHA combined with 0.5 mL lidocaine per hand usually appears to be sufficient to improve the appearance of the atrophic dorsum of the hand. Side-effects of CaHA (Radiesse), particularly in this off-label application, are minimal and of short duration. The aesthetic result is immediate and generally persists for longer than 6 months. As a treatment option, hand rejuvenation with CaHA (Radiesse) is a very gratifying procedure both to the patient and to the physician. [source]

Guidelines for the use of recombinant activated factor VII (rFVIIa) in uncontrolled bleeding: a report by the Israeli Multidisciplinary rFVIIa Task Force

JOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 4 2005
U. MARTINOWITZ
Summary.,Background:,Recombinant activated factor VII (rFVIIa) has been approved by the U.S. Food and Drug Administration (FDA) for almost a decade for hemophilic patients with inhibitors. Its off-label use as a hemostatic agent in massive bleeding caused by a wide array of clinical scenarios is rapidly expanding. While evidence-based guidelines exist for rFVIIa treatment in hemophilia, none are available for its off-label use. Objectives:,The aim of this study is to develop expert recommendations for the use of rFVIIa in patients suffering from uncontrolled bleeding (with special emphasis on trauma) until randomized, controlled trials allow for the introduction of more established evidence-based guidelines. Methods:,A multidisciplinary task force comprising representatives of the relevant National Medical Associations, experts from the Medical Corps of the Army, Ministry of Health and the Israel National Trauma Advisory Board was established in Israel. Recommendations were construed based on the analysis of the first 36 multi-trauma patients accumulated in the prospective national registry of the use of rFVIIa in trauma, and an extensive literature search consisting of published and prepublished controlled animal trials, case reports and series. The final consensus guidelines, together with the data of the first 36 trauma patients treated in Israel, are presented in this article. Results:,Results of the first 36 trauma patients: The prolonged clotting assays [prothrombin time (PT) and partial thromboplastin time (PTT)] shortened significantly within minutes following administration of rFVIIa. Cessation of bleeding was achieved in 26 of 36 (72%) patients. Acidosis diminished the hemostatic effect of the drug, while hypothermia did not affect it. The survival rate of 61% (22/36) seems to be favorable compared with published series of similar, or less severe, trauma patients (range 30%,57%). Conclusions:,As a result of the lack of controlled trials, our guidelines should be considered as suggestive rather than conclusive. However, they provide a valuable tool for physicians using rFVIIa for the expanding off-label clinical uses. [source]

Establishment of a pharmacoepidemiological database in Germany: methodological potential, scientific value and practical limitations

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 3 2008
Dipl., Iris Pigeot Dr rer.nat.
Abstract Purpose We present a new population-based pharmacoepidemiological (PE) database obtained from statutory health insurances (SHIs) that is able to generate signals, to monitor prescribed drugs and to describe drug utilisation. We discuss methodological features of the database and we assess to which degree this database reflects basic demographic characteristics and hospitalisation rates of the general population. Methods Files of three SHIs were linked with drug dispensation data from a pharmacies' electronic data processing centre on an individual basis using the unique subject identification number (ID) at a trusted third party centre. Plausibility checks and descriptive analyses were carried out. Results The database covers 3.6 million SHI-members, provides drug utilisation data and data on hospitalisations. SHI membership is fairly stable over time. Our data indicate marked differences in socio-demographic characteristics between SHIs. Hospital admission rates standardised for age vary between 0.164 and 0.229 per person year, which is in good agreement with official statistics (0.20). The age distribution shows good agreement for men and some underrepresentation for women above the age of 60 as compared to the general population. Conclusions Confounder information on medical conditions, concomitant medications and socio-demographic variables can be obtained from the database, while the assessment of confounders related to lifestyle requires supplementary data collection. The database allows for a population-based approach and reflects daily practice including off-label use of drugs. Independent recording of exposure and outcome data prevents reporting bias on medication or outcome. Legal conditions that allow continuous updating of the database need to be settled. Copyright © 2008 John Wiley & Sons, Ltd. [source]

What Should Work, May Not

AMERICAN JOURNAL OF TRANSPLANTATION, Issue 3 2010
A. D. Kirk
When new agents such as bortezomib appear, it is important to maintain scientific rigor regarding off-label use of medications. See brief communication by Sberro-Soussan et al on page 681. [source]

Incidence and Predictive Factors for Infectious Disease after Rituximab Therapy in Kidney-Transplant Patients

AMERICAN JOURNAL OF TRANSPLANTATION, Issue 1 2010
N. Kamar
Rituximab off-label use includes organ transplantation. We review the occurrence of infectious disease and its outcome after rituximab therapy. Between April 2004 and August 2008, 77 kidney-transplant patients received rituximab therapy [2,8 courses (median 4) of 375 mg/m2 each] for various reasons. Their results were compared with a control group (n = 902) who had received no rituximab. After a median follow-up of 16.5 (1,55) months for rituximab patients and 60.9 (1.25,142.7) months for control patients, the incidence of infectious disease was 45.45% and 53.9% (ns), respectively. The incidence of bacterial infection was similar between the two groups, whereas the viral-infection rate was significantly lower, and the rate of fungal infection was significantly higher in the rituximab group. Nine out of 77 patients (11.68%) died after rituximab therapy, of which seven deaths (9.09%) were related to an infectious disease, compared to 1.55% in the controls (p = 0.0007). In the whole population, the independent predictive factors for infection-induced death were the combined use of rituximab and antithymocyte-globulin given for induction or anti-rejection therapy, recipient age, and bacterial and fungal infections. After kidney transplantation, the use of rituximab is associated with a high risk of infectious disease and death related to infectious disease. [source]

The "art" of medicine and the "smokescreen" of the randomized trial off-label use of vascular devices,

CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 7 2008
FACC, Gary M. Ansel MD
Abstract Once a device is approved for sale in the United States by the Food and Drug Administration (FDA), it can legally be used by doctors to treat any condition a physician determines is medically appropriate. Based on postmarket published data and physician procedural experience, this may even become the standard of care when an alternative device either does not exist or is inferior in performance, even before FDA approval. This right of physicians to practice medicine without FDA approval is Federal law. The off-label use of medical devices for the treatment of peripheral vascular disease has recently become the latest target by groups with interests that have little to do with patient care. This interference has begun to negatively impact the latitude necessary for physicians to best treat their patients. © 2008 Wiley-Liss, Inc. [source]

In-label and off-label use of respiratory drugs in the Italian paediatric population

ACTA PAEDIATRICA, Issue 4 2010
P Baiardi
Abstract Aim:, To evaluate the prescription rate of respiratory drugs (ATC code R03) in an Italian community setting and to estimate the extent of off-label use by both age and indication. Methods:, A cohort study aimed at evaluating prescriptions of drugs with ATC code R03 was conducted for the period 2002,2006. Data source was the PEDIANET Database. Results:, Ninety percent of R03 prescriptions are covered by 11 active substances or combinations, corresponding to 67 medicinal products. Inhaled corticosteroids are the most prescribed anti-asthmatic agents, followed by short-acting ,2 mimetics. The mean off-label rate is 19 and 56%, by age and indication respectively. The majority of off-label uses is among children under the age of 2. Five active substances are used at dosages not supported by adequate dose-finding studies. Conclusion:, In Italy, many respiratory drugs are approved for the treatment of paediatric respiratory diseases, but a remarkable percentage of their prescriptions is off-label. This pharmaco-utilization study demonstrates that there is a need to perform clinical studies aimed at increasing the current knowledge on marketed paediatric drugs, and to revise and re-label the existing regulatory documents to reduce their off-label uses. [source]

Do Off-Label Drug Practices Argue Against FDA Efficacy Requirements?

AMERICAN JOURNAL OF ECONOMICS AND SOCIOLOGY, Issue 5 2008
A Critical Analysis of Physicians' Argumentation for Initial Efficacy Requirements
The amended Food, Drug and Cosmetics Act requires efficacy certification for a drug's initial uses ("on-label"), but does not require certification before physicians may prescribe the drug for subsequent uses ("off-label"). Does it make sense to require FDA efficacy certification for new drugs but not for new uses of old drugs? Using a sequential online survey, we carried on a "virtual conversation" with some 500 physicians. The survey asked whether efficacy requirements should be imposed on off-label uses; almost all physicians said no. It asked whether the efficacy requirements for initial uses should be dropped, and most physicians said no. We then asked respondents whether opposing efficacy requirements in one case but not the other involved an inconsistency. In response, we received hundreds of written commentaries. We organize and discuss these commentaries with an eye to understanding how the medical market certifies off-label drug uses and how this compares to FDA certification. Does off-label medicine use suggest that efficacy requirements should be placed on new uses of old drugs? Does it suggest that efficacy requirements on new drugs should be lifted? We explore these questions, and ask whether the response of many of the doctors exhibits the familiar behavior bias toward the status quo. [source]