Cytotec Induction and Off-Label Use • Midwifery Today
2). Lets take a careful look at the contents of this paper, as it is a superb example of torturing the data until it confesses to what the authors want it to say:. Prescribing a medication for an off-label indication is common in the treatment of pregnant women. This argument has no justification. Common usage of something does not prove it is a good idea. Experience in medical practice can often mean gaining more and more confidence in a mistake. Furthermore, as we have seen, some drugs have no serious risks involved while others carry very serious risks. And such widespread off-label prescribing is not found in other fields of medical practice.. 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. With the off-label use of Cytotec for labor induction there are several problems: First, no one can disagree that for a number of years in the early 1990s ...
Conflict of Interest Reporting by Authors Involved in Promotion of Off-Label Drug Use: An Analysis of Journal Disclosures
Background: Litigation documents reveal that pharmaceutical companies have paid physicians to promote off-label uses of their products through a number of different avenues. It is unknown whether physicians and scientists who have such conflicts of interest adequately disclose such relationships in the scientific publications they author. Methods and Findings: We collected whistleblower complaints alleging illegal off-label marketing from the US Department of Justice and other publicly available sources (date range: 1996-2010). We identified physicians and scientists described in the complaints as having financial relationships with defendant manufacturers, then searched Medline for articles they authored in the subsequent three years. We assessed disclosures made in articles related to the off-label use in question, determined the frequency of adequate disclosure statements, and analyzed characteristics of the authors (specialty, author position) and articles (type, connection to off-label use, ...
Some Doctors in the Dark About Off-Label Drugs - Redorbit
A number of physicians erroneously believed that certain off-label uses of prescription drugs were approved by the Food and Drug Administration (FDA), according to a recent national survey. Off-label use refers to prescribing a drug for a purpose outside the scope of a drugs approved label. The FDA makes it clear that they regulate the marketing of prescription drugs, not prescribing. The agency approves drugs for marketing with an official label that stipulates an indication, dose, intended population and duration of use. However, physicians and other licensed prescribers are free to prescribe any approved drug for any indication, whether or not the indication is included on the drugs FDA-approved label.. Our research shows that some off-label prescribing might be driven by mistaken beliefs about FDA approval and the level of evidence supporting off-label drug use, G. Caleb Alexander, MD, MS, Assistant Professor of Medicine at the University of Chicago Medical Center and corresponding ...
Abstract 5990: Off-Label Use of Drug-Eluting Stents Is Associated with a Reduction in All-Cause Mortality Compared with Bare...
Background: Several recent analyses have suggested that off-label (non-FDA approved) use of drug-eluting stents (DES) is associated with increased adverse events compared with their on-label use. However, it is unknown whether the use of bare metal stents (BMS) is better than use of DES for similar off-label indications.. Methods: We performed a pooled analysis of all registries that included patients who received either a DES or BMS, and provided data on their use for , 1 non-FDA approved indication. We pooled data across studies using random effects models.. Results: A total of 5 registries, which included 21,029 patients, were identified. Among the off-label indications included were STEMI (12.6%), in-stent restenosis (16.0%), vein graft interventions (16.3%), ostial lesions (16.4%) and chronic occlusions (18.2%). The weighted mean duration of follow-up was 15.6 months (range 9 to 36). Compared with BMS, DES were associated with a significant reduction in all-cause mortality (4.6% vs. 8.6, ...
Antibiotic Use in Children - Off-Label Use | Bentham Science
Title:Antibiotic Use in Children - Off-Label Use. VOLUME: 13 ISSUE: 7. Author(s):Walter Zingg and Klara M. Posfay-Barbe. Affiliation:Infection Control Program, University of Geneva Hospitals, 4 Rue Gabrielle Perret-Gentil, 1211 Geneva 14, Switzerland.. Keywords:Antibiotic therapy, children, infants, neonates, off-label use, off-licensed, unlicensed, frequency of drug application, paediatric, adverse drug reaction. Abstract:Systemic antibiotics are the group of drugs most commonly used in children. Off-label antibiotic use in children is still common in the community and in hospitals, mostly because of young age, dosage, or frequency of drug application. There is an important incentive gap that hinders paediatric drug development resulting from a series of factors, such as small market size, a predominance of off-patent use, no incentives for generic drug manufacturers, and a greater complexity of drug development. The latter is due to varying capacities of drug absorption and metabolism during ...
Off-label drug use in a single-center pediatric cardiac intensive care by Lily A. Maltz, Darren Klugman et al.
Maltz, L.A., Klugman, D., Spaeder, M.C., Wessel, D.L. (2013). Off-label drug use in a single-center pediatric cardiac intensive care unit. World Journal of Pediatric Congenital Heart Surgery, 4(3), 262-266.. ...
Off-label Use of Device to Prevent Stroke in A-fib Patients Can Be Fatal | thirdAGE | healthy living for women + their families
The Lariat device, which has been cleared by the U.S. Food and Drug Administration (FDA) for soft tissue approximation (placement of a suture) during surgical procedures, is associated with a significant incidence of death and urgent cardiac surgery during its frequent off-label use to prevent stroke in patients with the irregular heartbeat known as atrial fibrillation. Following a systematic review of case reports and an FDA safety database, researchers at the Perelman School of Medicine at the University of Pennsylvania are calling for formal controlled investigations into the safety and efficacy of off-label use of the Lariat device, which has never been approved for treatment of this condition. Their study results was published May 2015 in JAMA Internal Medicine.. A release from the university quotes study senior author Jay Giri, MD, MPH, assistant professor in the Cardiovascular Medicine Division at Penn, as saying, Not only do we believe that high-quality, randomized clinical trials are ...
Off-label drug marketing study: Insidious forms of illegal marketing | Medpage Today
The commonest goal (85% of cases) was expansion of drug use to unapproved diseases (for example, gabapentin, which is approved for the treatment of specific types of epilepsy, was allegedly promoted as a therapy for patients with psychiatric diseases such as depression). The other goals were expansion to unapproved disease subtypes (for example, some antidepressant drugs approved for adults were allegedly promoted to pediatricians for use in children) and expansion to unapproved drug dosing strategies, typically higher doses. The researchers also identified four non-mutually exclusive types of marketing practices designed to achieve these goals. All of the whistleblowers alleged prescriber-related practices (including providing financial incentives and free samples to physicians), and most alleged internal practices intended to bolster off-label marketing, such as sales quotas that could only be met if the manufacturers sales representatives promoted off-label drug use. Payer-related practices ...
Surprises of off-label drug use: where had all the Prostin gone?
IVJohn Lawrenson is a senior lecturer in the Department of Paediatrics and Child Health at the University of Stellenbosch. The off-label use of drugs is common, particularly in paediatrics, where many drugs have yet to undergo the rigorous scrutiny demanded by authorities such as the Medicines Control Council (MCC) and the US Food and Drug Administration (FDA) before registration.1,2 Yet some drugs (e.g. paracetamol, salbutamol) are so commonplace in paediatric practice that it may come as a surprise that their use is indeed off-label in many circumstances. Problems may arise when an important drug in everyday (off-label) use is unexpectedly in short supply. An example is dinoprostone, marketed in South Africa as Prostin E2 by Pfizer South Africa (but curiously not listed on their website). Its registered use in South Africa is for induction of labour (as an oral 0.5 mg tablet), yet it is commonly used in South Africa for the emergency maintenance of ductal patency in newborn babies. ...
Off-label drug prescriptions in French general practice: a cross-sectional study | BMJ Open
Our estimation of off-label prescribing frequency (18.5%) is close to the estimation of an American reference study (21%) in community medicine in 2001, based only on the indication criteria.19 A French study in 2012, limited to 11 clinical situations, found that 19.3% of general practice prescriptions were off-label.26 Our results are even more significant given the high average level of drug prescribing in France, with more than 80% of general practice consultations resulting in at least one drug prescription.18 To the best of our knowledge, no previous study has examined patient information when they receive off-label prescriptions.. We can identify two types of off-label prescriptions: whether they are scientifically justified or not. Only 27% of off-label prescriptions were considered justified in the USA in 2001.19 Off-label prescribing is indeed not always wrong or harmful, especially when complying with clinical practice guidelines, since they are usually elaborated according to SPC. ...
Tetracyclines inhibit connective tissue breakdown by multiple non-antimicrobial mechanisms.<...
TY - JOUR. T1 - Tetracyclines inhibit connective tissue breakdown by multiple non-antimicrobial mechanisms.. AU - Golub, L. M.. AU - Lee, H. M.. AU - Ryan, M. E.. AU - Giannobile, W. V.. AU - Payne, J.. AU - Sorsa, T.. PY - 1998/11. Y1 - 1998/11. N2 - A seminal experiment involving a germ-free rat model of connective tissue breakdown (followed soon thereafter by a series of in vitro studies) identified an unexpected non-antimicrobial property of tetracyclines (TCs). This ability of TCs to inhibit matrix metalloproteinases (MMPs) such as collagenase was found to reflect multiple direct and indirect mechanisms of action, and to be therapeutically useful in a variety of dental (e.g., adult periodontitis) and medical (e.g., arthritis, osteoporosis, cancer) diseases. The site on the TC molecule responsible for its MMP-inhibitory activity was identified which led to the development of a series of chemically modified non-antimicrobial analogs, called CMTs, which also have therapeutic potential but do ...
Are drugs prescribed for off-label uses safe to take? - News - Sarasota Herald-Tribune - Sarasota, FL
Q:My doctor suggested I take anti-seizure medication for my migraines, but its not approved for that. He says its safe and effective. Whats your take? -- Evelyn P., Council Bluffs, IowaA:In the United States, 4.02 billion prescriptions are written annually, and more than 20 percent are to treat diseases or conditions for which the drugs are not specifically Food and Drug Administration-approved. Thats called off-label use, and it is perfectly legal. In fact, more than half of all uses of
Medtronic is Named By Nearly 100 Victims in Lawsuit for Allegedly Touting Off-Label Uses of Infuse Bone Graft; Parker Waichman...
New York, NY (PRWEB) October 03, 2013 Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, working with Lanier Law Firm, based in Houston, Texas; Neblett, Beard & Arsenault, in Alexandria, La.; The Drakulich Firm, APLC, in San Diego, Cal.; and Holland, Groves, Schneller & Stolze LLO, in St. Louis, Mo., on Oct. 1 filed with the 22nd Circuit Court in St. Louis, Missouri, a Complaint that names 98 Plaintiffs in a lawsuit against Defendants Medtronic Inc., Medtronic Sofamor Danek USA, Inc. and 100 John Does, or those whose name is not yet known (Lucas Gayer et al v. Medtronic Inc., et al, Case No. 1322-CC09531). The lawsuit is in response to the device makers alleged long history of supporting and promoting off-label uses (meaning uses not approved by the U.S. Food and Drug Administration (FDA)) for its Infuse bone graft product.. According to a Sept. 22, 2010 Medtronic post on the companys website, Infuse is positioned as a way ...
Off-Label Use of Intravenous Immunoglobulin for Dermatological Conditions: Clinical Effectiveness | CADTH.ca
Twenty-one systematic reviews and meta-analyses and five randomized controlled trials were identified regarding the clinical effectiveness of the off-label use of intravenous or subcutaneous immunoglobulin for the treatment of dermatological conditions.. ...
Didronel (etidronate) Side Effects, Dosage, Uses, Off-Label Use
Didronel (etidronate) is a drug prescribed for the treatment of Pagets disease and the prevention of heterotopic ossification. Off-label uses include the prevention of postmenopausal osteoporosis and treatment of hypercalcemia. Side effects, drug interactions, and pregnancy and breastfeeding information is provided.
Avastin Off-Label Use, Infection, Blindness Risk - Parker Waichman LLP
Avastin Off-Label Use Injury Lawsuits. Avastin, a drug approved to treat certain cancers, has been associated with severe, painful.
Off-label use of recombinant factor VIIa in patients following bone marrow transplantation. - Nataonline
This is a report on off-label extended use of rFVIIa in managing pulmonary, vesical and GI haemorrhage in 3 patients post-BMT, who failed to respond to blood component transfusion and haemostatic medications. rFVIIa resulted in partial control of haemorrhage in 2 patients, and no effect in the third. No toxicity or adverse events were noted.. - M. Aldouri. ...
ATOPIC DERMATITIS clinical guidelines | CredoWeb
Various factors must be considered when prescribing systemic agents, such as previous therapy failure or contraindications, as well as quality of life and disease severity. When using systemic agents, the minimal effective dose should be used, because there is no optimal dosing, duration, or monitoring protocol due to the lack of data. Treatment is highly individualized and based on patient response, comorbidities, and history.. The following systemic therapies can be used off-label to treat AD. Some should only be considered as an alternative when other more commonly used off-label systemic therapies are not an option:. Cyclosporine: off-label use for ...
Off-Label Drug Bill: What It Could Mean To You And Why Insurers Want To Kill It - Hartford Courant
Proposed legislation would enhance the likelihood of off-label drug coverage for all patients, not limited to specific conditions, by updating Connecticut's almost embarrassingly archaic law.
Off-Label Use of Biliary Stents Dominates Malfunctions and Adverse Events | Medpage Today
BOSTON -- Biliary stents used off-label in the peripheral vasculature accounted for up to 80% of the malfunctions and adverse events attributed to the devices, researchers here found.
The Neurontin Controversy: The Saga of Off Label Drug
Regulation Continues
THE NEURONTIN CONTROVERSY:. THE SAGA OF OFF-LABEL DRUG REGULATION CONTINUES. Robert Kaufman. Class of 2004. April 27, 2004. Submitted in satisfaction of 3L written requirements and the requirements of the 2004 Food and Drug Law Course. ABSTRACT. The regulation off-label drugs is a complicated and controversial area of the law. Regulators must protect patients safety without interfering with physicians practice of medicine or manufacturers First Amendment rights. The recent Neurontin decisions, which apply the doctrine of false claims to prescription drug regulation, only adds additional complexity. This paper explores the federal governments attempts to regulate the promotion of off-label drugs. It discussed the advantages and disadvantages of off-label marketing, the current regulatory environment, and the implications of the Neurontin lawsuit.. I. Introduction. On October 2, 2003, Philadelphia Assistant U.S. Attorney Virginia Gibson delivered a speech to the Pharmaceutical Compliance Forum ...
What is HGH? - Naturopathic Doctor News and Review
Although controversial, off-label prescribing of drugs or devices (product) is an important component of modern medicine. Off-label use is when a product is prescribed for circumstances that have not been approved by the FDA. Once the FDA approves a product for marketing, it is at the physicians discretion to prescribe the product for indications or population groups, typically geriatrics or pediatrics, that are not included on the label. Drugs may be administered by methods or at dosages not specified on the label; the omission of a use on a products label simply means that the FDA has not yet reviewed the product for that particular use.. In general, it is the medical community which has the responsibility of determining when off-label prescribing is appropriate. Physicians must determine that there is sufficiently solid evidence to justify off-label use prior to prescribing and are justified in prescribing off-label uses of product when backed by scientific and medical evidence.8 HGH is an ...
Systematic Review: Benefits and Harms of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications | Annals of...
Data Synthesis:. 16 RCTs, 26 comparative observational studies, and 22 noncomparative observational studies met inclusion criteria. Identified comparators were limited to placebo (RCTs) or usual care (observational studies). For intracranial hemorrhage, mortality was not improved with rFVIIa use across a range of doses. Arterial thromboembolism was increased with medium-dose rFVIIa use (risk difference [RD], 0.03 [95% CI, 0.01 to 0.06]) and high-dose rFVIIa use (RD, 0.06 [CI, 0.01 to 0.11]). For adult cardiac surgery, there was no mortality difference, but there was an increased risk for thromboembolism (RD, 0.05 [CI, 0.01 to 0.10]) with rFVIIa. For body trauma, there were no differences in mortality or thromboembolism, but there was a reduced risk for the acute respiratory distress syndrome (RD, −0.05 [CI, −0.02 to −0.08]). Mortality was higher in observational studies than in RCTs. ...
List of off-label promotion pharmaceutical settlements - Wikipedia
The following are settlements reached against pharmaceutical companies to resolve allegations of off-label promotion of drugs. Under the Federal Food, Drug, and Cosmetic Act, it is illegal for pharmaceutical companies to promote their products for uses not approved by the Food and Drug Administration (FDA), and corporations that market drugs for off-label indications may be subject to civil liability under the False Claims Act as well as criminal penalties. Descriptions of the lawsuits are listed in chronological order. In 1996, whistleblower David Franklin left his position as a medical liaison with Parke-Davis, a pharmaceutical division of Warner-Lambert Company, after learning of the companys marketing strategy to promote the epilepsy drug Neurontin for uses not approved by the FDA. Franklin and his attorney, Thomas M. Greene, filed a lawsuit, Franklin v. Parke-Davis, under the False Claims Act in federal district court in Boston. In the first off-label promotion case ever litigated in a ...
Our Key Issues - The Tatia Oden French Memorial Foundation
Maternal Mortality: When a woman dies during pregnancy, childbirth, or within the twelve-month period following childbirth, due to pregnancy-related issues.. Off-Label Use of Drugs: Once a drug is approved by the FDA it can be used by ANY doctor, for any reason. This practice is called the off-label use of drugs. There is no mandatory reporting system for side effects of drugs used off-label.. Informed Consent: The Foundation believes that TRULY informed consent occurs when ALL the possible side effects of a drug or medical intervention are made known to the patient. Only then can a woman and her family make fully informed decisions regarding the use of these procedures and drugs.. Cytotec: A drug created for the treatment of stomach ulcers by Searle. Used off- label to induce labor by ripening the cervix. Also used as a component in RU486 (the abortion drug). Though it is not approved by the FDA for inducing labor, Cytotec has become the standard of care for inducing labor.. For more ...
Drug Criteria & Outcomes: Off-label drug use: Etanercept (Enbrel) for Crohns disease? | 2003-05-01 | AHC Media: Continuing...
Crohn s disease, one major type of inflammatory bowel disease, has an incidence rate in the United States of approximately seven per 100,000. Advancing biotechnological knowledge regarding this idiopathic disease has led to the development of therapies aimed at specific targets in the disease pathway.
CMA REPORT: MEDICARE COVERAGE FOR OFF-LABEL DRUG USE || Center for Medicare Advocacy
The Center for Medicare Advocacy, is a national nonprofit, nonpartisan law organization that provides education, advocacy and legal assistance to help older people and people with disabilities obtain fair access to Medicare and quality health care.
Horses and Off-Label Drug Use: What Every Owner Should Know | Horse Authority
For those of us who own horses, but are untrained in veterinary medicine, understanding guidelines may protect the health and lives of our beloved horses.
Off-label drug use during labor could result in a tragedy | Furr & Henshaw
Pregnancy is often a time that is both terrifying and full of joyful expectation. Mothers-to-be often do anything in their ... blog
Off-label drug use can lead to death | Piro Zinna Cifelli Paris & Genitempo LLC
Two doctors have lost their jobs, 16 offices were investigated, and the entire state of New Jersey was given an alert about ... Personal Injury
Evelyn Pringles Catalog of Articles: High Death Rate Reported With Bayers Trasylol
Despite the approval for limited use, Trasylol has been used off-label with many patients undergoing other types of surgery. In fact, the rate of off-label use far exceeds the rate of on-label use. The FDAs Adverse Event Reporting System shows that the majority of adverse events reported, or about 75%, occurred in patients who received Trasylol for an unapproved use, with heart valve replacement being the most frequent ...
Botulinum toxin in clinical practice | Journal of Neurology, Neurosurgery & Psychiatry
Dear Editor Jankovic reviews the expanding list of approved and off-label indications for therapeutic use of botulinum toxin (BT). [1]. One of the prominent off-label indications for use of BT is migraine, the advent of which therapy was serendipitous. Use of BT for migraine prevention is gaining momentum through the results of randomized controlled trials (RCT) - both completed and ongoing - and, in the effort to evolve a broad consensus, certain clinical reservations have been recently addressed [2]. In this period of elucidation of anti-migraine mechanisms of BT that would eventually lead towards formal approval of its use for clinical practice, it is important to maintain an open, cautious, and critical approach to the literature. A direct skeletal muscle-spasmolysis independent prolonged analgesic action is believed to underlie efficacy of BT in preventing migraine attacks for three months or more [2-4]. The following facts do not sustain this theoretical premise: (i) Three RCTs in human ...
Dosing - Immunoglobulin (Ig) Therapy
When dosing for off-label indications where high-dose therapy is employed, such as in neurology, the starting dose is typically 2 grams/kg given over a 5 day period. If the patient has a good response, maintenance dosing is required and often patients are not dosed frequently enough or with a high enough dose. Again, this is often due to a lack of published studies in these off-label indications. We found that the best way to manage these patients was to dose frequently and with a high enough dose to prevent the symptoms from recurring; similar to how pain is best managed. Once the patient was being dosed such that his/her symptoms did not return, we would then lower the dose or increase the interval to find the most optimal therapy that resulted in the lowest cost. By employing this methodology, all of our neurology, rheumatology and dermatology patients had complete resolution of their disease symptoms ...
How Augmentin ES Works and Off-Label Indications
If you are curious about how the antibiotic Augmentin ES works to treat ear infections, this eMedTV Web page can help. It takes an in-depth look at the drugs effects and also discusses
How Cipro HC Works, Who Can Take It, and Off-Label Indications
This eMedTV page addresses the question of whether Cipro HC can be used in children and older adults. This Web page also discusses
Background The potential risks and great things about off-label usage of - INNO-406 reverses multidrug resistance by inhibiting...
Background The potential risks and great things about off-label usage of recombinant factor VIIa in patients without hemophilia are contested. transfused (comparative risk 0.71, 95% CI 0.50 to 0.99). In the healing trials, we discovered a nonsignificant reduction in mortality and a non-significant upsurge in thromboembolic occasions but no difference in charge of bleeding or Ercalcidiol crimson bloodstream cell transfusion. Interpretation Medically significant great things about recombinant aspect VIIa as an over-all hemostatic agent in sufferers without hemophilia stay unproven. Provided its potential dangers, such use cant be suggested, and generally, it ought to be restricted to scientific trials. Recombinant aspect VIIa is normally a hemostatic agent certified for the treating bleeding in sufferers with hemophilia whove inhibitors. Additionally it is used off-label for the procedure and avoidance of blood loss in sufferers without hemophilia. In the Australian and New Zealand Haemostasis ...
County Durham & Tees Valley Formulary
NTAG September 2015: The Northern (NHS) Treatment Advisory Group recommends the use of infliximab biosimilars as an option where the originator product (Remicade®) would normally be prescribed.. NTAG June 2020: The Northern (NHS) Treatment Advisory Group recommends Remsima SC® be available as additional treatment option during the COVID-19 pandemic for both licensed and off-label uses as part individual hospital Trust management strategies to reduce hospital day case admissions, and keep immunosuppressed people out of hospital during the COVID-19 pandemic. Remsima SC® could be considered as an option where the patient would otherwise get the intravenous Remsima® formulation of Infliximab. This recommendation is subject to any off-label use of Remsima SC® being considered and approved via individual hospital trust governance processes (including clinical governance) for the use of unlicensed/off-label drugs. It was also agreed that this recommendation would be reviewed after 12 ...
Rutgers Study Finds Increase in Off-Label Medication Orders for Children
U.S. physicians are increasingly ordering medications for children for conditions that are not approved by the Food and Drug Administration, according to a Rutgers study.. The findings highlight the need for more education, research and policies addressing effective, safe pediatric drug prescribing.. The study, published in the journal Pediatrics, analyzed data collected from 2006 to 2015 in the Centers for Disease Control and Preventions National Ambulatory Medical Care Surveys, which provide information on doctor office visits across the U.S. The researchers analyzed the frequency, trends, and reasons why doctors ordered unapproved medications for children under 18.. It is the first study in a decade to look at how U.S. doctors outside of hospitals order a broad range of medicines off-label to children. This study focused on systemic drugs, which work throughout the body and have a greater potential for toxicity.. Many drugs prescribed for children have not been rigorously tested in children, ...
bad science - Bad Science
Heres a paper, and associated website, that we launch today: we have assessed, and then ranked, all the biggest drug companies in the world, to compare their public commitments on trials transparency. Regular readers will be familiar with this ongoing battle. In medicine we use the results of clinical trials to make informed treatments about which treatments work best; but the results of clinical trials are being routinely and legally withheld from doctors, researchers, and patients. This is a problem for industry sponsored trials, and for trials funded by governments and charities.. So what did we find? The results on the individual companies are important, but we also came across some fascinating patterns. While companies superficially have commitments to register and report clinical trials, in reality, there are often huge gaps in their policies, with many failing to include past trials (trials on the medicines we use today) and trials on off-label uses or unlicensed medicines, which are ...
The RITAI Cohort: An Observational Study on Rituximab Off-label Use for Auto-immune Disorders - Full Text View - ClinicalTrials...
Every patient treated by rituximab off-label for auto-immune diseases in the public hospitals of the Midi-Pyrénées County (South of France) is eligible for the study, whatever the dose and planned infusions number. The enrolment is definitive when the first rituximab infusion begins. Follow-up visits are planned at months 1, 3, 6, 12 and 18 after the first infusion. At each visit, the investigators will record the adverse events that have occurred since the last visit. Serious or unexpected adverse events will be systematically monitored and declared to the Department of Pharmacology Pharmacovigilance unit and to Health Authorities (AFSSAPS). Imputability will be quoted according to the French method. A biological collection will be constituted to allow pharmaco-immunological studies ...
Medication Profile - Zonegran Off-Label Use for Migraine - Migraine
Theres a wide variety of medications used for Migraine, most of which are prescribed off-label. If Zonegran (zonisamide) has been prescribed for you, or if you and your doctor have been considering i
Arizona Judge Rejects Medtronic Inc.s Efforts to Dismiss a Lawsuit That Alleges the Company Promoted Off-Label Use of Its...
Health,(PRWEB) August 26 2013 Parker Waichman LLP a national law firm dedicated to protecting the rights of victims injured by defective medical devices notes that according to court documents filed w,Arizona,Judge,Rejects,Medtronic,Inc.s,Efforts,to,Dismiss,a,Lawsuit,That,Alleges,the,Company,Promoted,Off-Label,Use,of,Its,Infuse,Bone,Graft,Product,,Parker,Waichman,LLP,Reports,medicine,medical news today,latest medical news,medical newsletters,current medical news,latest medicine news
Failure Modes and Effects Analysis: Off-Label Use of Alaris Infusion Pump for Cerebrospinal Fluid Subarachnoid Drainage
...
Communicating hydrocephalus is a medical conditionthat occurs when there is an imbalance between production and absorption of cerebrospinal fluid (CSF) resulting in increased intracranial pressure. One treatment for the condition involves draining excess CSF. A custom CSF drainage system was designed by clinical staff from Vancouver Coastal Health. The system uses an infusion pump off-label to drain CSF from a catheter inserted into the patients lumbar spine. A Failure Modes and Effects Analysis (FMEA) of the system was conducted to assess the risk of the therapy from an equipment perspective. The FMEA identified thirty-one device hazards. Highest ranked hazards included operating the device without drug-error reduction system controls, operator error resulting in improper system setup, and potential patient harm due to the device controlling flow rate instead of CSF pressure.. ...
Antidepressant and placebo are equally effective in child p... ( Bethesda MD (Oct. 1 2009) When used...)
Health, ...Bethesda MD (Oct. 1 2009) When used off-label the antidepressant... Many pharmaceutical products are prescribed for off-label use in chil...Amitriptyline (Elavil) is used to treat symptoms of depression howeve...Doctors designed a large prospective multicenter randomized placebo-...,Antidepressant,and,placebo,are,equally,effective,in,child,pain,relief,medicine,medical news today,latest medical news,medical newsletters,current medical news,latest medicine news
Big Pharma and Health Care: Unsolvable Conflict of Interests Between Private Enterprise and Public Health/Commentary/Authors...
By Brezis, Mayer Belmaker, R H Mayer Brezis, MD, MPH Center for Clinical Quality & Safety, Hadassah Medical Center & School of Public Health, The Hebrew University of Jerusalem, Israel Abstract: A landmark paper on Game Theory showed that individual maximization of profit necessarily endangers the public good, and since the problem has no technical solution, it requires a fundamental extension in morality (1). We propose here that public health, as a public good, now emerges as a grave example of this problem. Recent events and reports increasingly suggest misalignment between the interests of the pharmaceutical industry and those of public health. Johnson & Johnson illegally and effectively promoted Propulsid off-label for children despite internal company documents raising safety concerns. Death in drug trial has been described as a trade secret. On Vioxx, Topol wrote: Sadly, it is clear that Mercks commercial interest exceeded its concern about the drugs toxicity (2). More and more ...
The perils of poultry
The article reports on the concern of the Public Health Agency of Canada (PHAC) on the widespread off-label utilization of cephalosporin antibiotics in poultry hatcheries and its implications to public health. The health agency has indicated the role of the off-label use of cephalosporin in driving human resistance to the antibiotics. Moreover, Health Canada has introduced nonbinding labels warning against off-label use of cephalosporins in agriculture. Information on the Canadian Integrated Program for Antimicrobial Resistance (CIPARS) which covers the issue is also explored ...
Red Cat Belly Rash | The Internet Vet
First of all, steroids are not FDA approved for use in cats in the United States. They, along with about 80% of pet medicine, are prescribed as an off-label use. Off-label means the research may be good, doctors have been prescribing it for a while, everybody thinks they know the doses and benefits and risks. However, an off-label drug has not been put through the expensive, intensive US FDA process of formal drug approval for that species of animal.. In cats, prednisone, prednisolone, methylprednisolone, and other steroids, have been reported by researchers to unmask hidden heart disease. Approximately 15% of cats may be walking around with cardiac muscle disease with absolutely no outward signs or symptoms. If your cat is one of these cats, a steroid could precipitate sudden decompensation of the heart, and lead to the symptoms of heart failure and sudden death. Your veterinarian may recommend cardiac health screening before prescribing a steroid.. A cat with hidden cardiac disease may get ...
HCV Research and News: 05/05/14
Andrew Aronsohn,1,2 Nancy Reau,1 and Donald Jensen1. The next generation of direct-acting antiviral agents (DAAs) will change the landscape of hepatitis C virus (HCV) therapy. Approval of complimentary oral agents will also introduce new opportunities for off-label treatment. Off-label therapy in HCV will include (1) combinations of approved drugs, used for the approved indication in an unapproved combination, such as combining two DAAs in an interferon (IFN)-sparing regimen, and (2) combinations of approved drugs used in an unapproved combination for an unapproved indication, such as using two available DAAs to treat patients post-LT (liver transplantation). Both providers and patients might find off-label combinations attractive; however, there may be limited data to support safety and efficacy. These treatment choices may also go against the recommendations published in therapeutic guidelines.. This article will address anticipated issues regarding off-label use of HCV medications, including ...
Potential application of a chemically modified non-antimicrobial tetracycline (CMT-3) against metastatic prostate cancer.<...
TY - JOUR. T1 - Potential application of a chemically modified non-antimicrobial tetracycline (CMT-3) against metastatic prostate cancer.. AU - Lokeshwar, B. L.. AU - Houston-Clark, H. L.. AU - Selzer, M. G.. AU - Block, N. L.. AU - Golub, L. M.. PY - 1998/11. Y1 - 1998/11. UR - http://www.scopus.com/inward/record.url?scp=0032198323&partnerID=8YFLogxK. UR - http://www.scopus.com/inward/citedby.url?scp=0032198323&partnerID=8YFLogxK. U2 - 10.1177/08959374980120012901. DO - 10.1177/08959374980120012901. M3 - Article. C2 - 1999125161. AN - SCOPUS:0032198323. VL - 12. SP - 97. EP - 102. JO - Advances in dental research. JF - Advances in dental research. SN - 0895-9374. IS - 2. ER - ...
Off-Label Use of Antipsychotics Alarms Experts | Promises Behavioral Health
Turn on the TV for two or three hours and youre likely to see a commercial for Abilify - one of the newer antipsychotic medications being used to treat a variety of symptoms and disorders. Its advertised as an adjunct medication for those taking antidepressants for depression who arent quite experiencing the benefits theyd hoped for. Antipsychotics, as the name suggests, were primarily developed to treat symptoms of psychosis. For years, they were used almost exclusively for the treatment of the two most common psychotic disorders - schizophrenia and schizoaffective disorder. The two most common psychotic symptoms are hallucinations - e.g. hearing voices - and delusions - e.g. the bizarre belief that aliens are controlling your mind via an implanted microchip. For many individuals suffering from psychosis, these medications have been life-changing. Schizophrenia is one of the most debilitating and serious psychiatric disorders known to humankind. These drugs - which were first used in the ...