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, ...
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 ...
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, ...
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 ...
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.. ...
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 ...
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. ...
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 ...
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 ...
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 Injury Lawsuits. Avastin, a drug approved to treat certain cancers, has been associated with severe, painful.
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 ...
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.
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. 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 ...
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 ...
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. ...
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 ...
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 ...
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.
Pregnancy is often a time that is both terrifying and full of joyful expectation. Mothers-to-be often do anything in their ... blog
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 ...
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
This eMedTV page addresses the question of whether Cipro HC can be used in children and older adults. This Web page also discusses
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 ...
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 ...
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
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
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.. ...
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
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 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 ...
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 ...
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 ...
One of the top classes of over-prescribed drugs are the new generation of atypicals antipsychotics that were adopted because of claims by drug makers that they were safer, more effective and produced fewer side effects than the older antipsychotics. However, over the past several years, drug companies have been forced to admit to misleading the FDA, physicians, and consumers about the deadly side effects associated with these drugs including an increased risk of suicide. According to Harvard trained psychiatrist, Dr Stefan Kruszewski, "the new generation of antipsychotics substantially increase the risk of obesity, diabetes type II, hypertension, cardiovascular complications, heart attacks and stroke." "The drug causes both a severe metabolic syndrome and cardiovascular problems," he explains, "at the same time that they continue to cause neurological side effects like the older typical antipsychotics." Dr Kruszewski says the drug makers knew of many of these side effects but withheld the data ...
The FDA also horsed around so long before releasing the cancer drug Erbitux that Patient Abigail, aged 21, died of her cancer on the very day that the FDA decided that it would give a Dispensation in just this one case and allow her doctor to use the drug as a last-ditch measure.. Here is a video of a debate on Off-Label Drug Usage, between Prof. Richard Epstein of the U. of Chicago and New York University Law Schools, and Dr. Ryan Abbott. Prof. Epstein is an eminent libertarianish Classical Liberal who knows a good deal about many areas of law, including patent law and laws affecting the pharmaceutical industry. His creds are more than solid. Theres plenty in it that speaks to our topic here, and both sides of the argument are well represented. 56 minutes.. UToob-dot-com/watch?v=o8x3dGtBtVk. A little different angle but just as good, Prof. Epsteins discussion with Russ Roberts of EconTalk, in a podcast entitled "Property Rights and Drug Patents. Audio, a little over an ...
The lawsuit also accuses Chevron of abandoning more than 900 unlined waste pits gouged out of the jungle floor that leech toxins into soils and streams; contaminating the air by burning the waste pits; dumping oil along roads; and spilling millions of gallons of pure crude from ruptured pipelines. Internal company documents demonstrate that Chevron officials ordered field workers to destroy records of oil spills, that the company refused to develop an environmental response plan or pipeline maintenance program, and that Chevron never conducted a single health evaluation or environmental impact study despite the obvious harm it was causing ...
This may be the knock-out round for Roundup, Monsantos top selling weed killer, after the European Parliament late last year called for an outright ban on the glyphosate-based herbicide.. MEPs opposed the European Commissions proposal to renew the products licence for another 10 years and, instead, demanded immediate curbs on domestic use and a later ban for farming when alternative pest control measures are in place.. The release of the "Monsanto Papers", the internal company documents that shed doubt on the credibility of some studies used in the EU evaluation on glyphosate safety, have brought the potential health risks of Roundup to the fore.. "Its vital that we have one eye firmly on the future when considering the use of agrochemicals in food production. Taking steps to reduce the risks of long-term harm from the way our food is produced is essential if we are to build a resilient and sustainable food system," Dan Crossley, executive director of the UKs Food Ethics Council, told ...
Westby G. Fisher, MD, FACC is a board certified internist, cardiologist, and cardiac electrophysiologist (doctor specializing in heart rhythm disorders) practicing at NorthShore University HealthSystem in Evanston, IL, USA and is a Clinical Associate Professor of Medicine at University of Chicagos Pritzker School of Medicine. He entered the blog-o-sphere in November, 2005. DISCLAIMER: The opinions expressed in this blog are strictly the those of the author(s) and should not be construed as the opinion(s) or policy(ies) of NorthShore University HealthSystem, nor recommendations for your care or anyone elses. Please seek professional guidance instead ...
Intracranial stents 2019: In general, intracranial stenting is still performed in rare cases, but only when other forms of medical therapy have failed.
This drug is a cholinesterase inhibitor and is used in mild-to-moderate AD. Immediate-release (IR) tablet or solution: Initially 4 mg twice daily for 4 weeks; if tolerated, increase to 8 mg twice daily for ≥4 weeks; if tolerated, increase to 12 mg twice daily.9. Extended-release (ER) Capsule: Initially 8 mg once daily for 4 weeks; if tolerated, increase to 16 mg once daily for ≥4 weeks; if tolerated, increase to 24 mg once daily. If therapy is interrupted for ≥3 days, restart at the lowest dose and increase to current dose.. Severe AD (Off-label Use): IR tablet: 4 mg twice daily for 4 weeks; if tolerated, increase to 8 mg twice daily for ≥4 weeks; if tolerated, increase to 12 mg twice daily. May decrease to 8 mg twice daily if the target dose is not tolerated.. Dementia Associated With Parkinsons Disease and Lewy Body Dementia (Off-label Use): American Psychiatric Association recommends dosing and titration similar to those for patients with AD.9,10. Conversion From IR to ER ...
Topamax is an antiseizure drug from Ortho-McNeil with many off-label uses. One off-label use is as a weight-loss drug. Many Topamax users have experienced...
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Although Luvox is approved for the treatment of OCD, this eMedTV selection explains that it may also be prescribed for an unapproved condition, such as anxiety. This page lists other off-label uses and explores whether children can take this drug.
At 2-and-a-half-years-old, Rebecca was diagnosed with attention deficit disorder and bipolar disorder and was prescribed Zyprexas atypical cousin, Seroquel, along with Clonidine, an adult high blood pressure drug, and Depakote, a drug approved to treat adults with epilepsy. None of these drugs were approved for children and they were prescribed in a combination that has never been tested even with adults.. From age 2 on, Rebecca remained on this daily drug off-label concoction until she was found dead on the floor in her parents home on December 13, 2006. The autopsy report stated that she died of the combined effects of the drugs and that her lungs and heart were damaged by prolonged abuse of these prescription drugs, rather than one incident. Experts say, this case reinforces the assertion that judges have got to quit allowing drug makers to seal documents with court orders that show the side effects of drugs and the illegal conduct of promoting the sale of drugs for unapproved ...
A New York court ruled this week that a formerly convicted salesmans off-label promotion is protected under his right to free speech, potentially tearing down certain of the FDAs abilities to regulate and penalize medical device and drug marketing.. A 3-judge panel for the 2nd Circuit Court of Appeals vacated a ruling against Alfred Caronia, who was convicted in 2009 for illegally marketing narcolepsy Xyrem for uses that werent approved by the FDA. ...
This study was conducted to provide an overview of the worldwide trend in off-label prescribing in children from the year 1996 to 2016.. DATA SOURCES: The articles published in PubMed, MEDLINE and Google Scholar were searched using text words: off-label, unlicensed, paediatric and children. Additional articles were identified by reviewing the bibliography of the retrieved articles. Full-text articles published in English which reported on the prevalence of off-label prescribing in children between January 1996 and December 2016 were included.. RESULTS: A total of 101 studies met the inclusion criteria. Off-label prescribing definition included four main categories: age, indication, dose and route of administration. The three most common reference sources used in the studies were summary of product characteristics, national formularies and package inserts. Overall, the off-label prescribing rates in children ranged from 1.2 to 99.7%. The most common category of off-label prescribing in children ...
About half of all anticancer drugs are prescribed off-label. Learn how to handle off-label insurance coverage through the MPN Research Foundation here.
This drug is unequivocally experimental and risky. Thats why, back in February, I organized interested members of the Bioethics community to fight to make sure every woman offered dex for CAH knows the truth about its experimental and risky nature. (You can read about our efforts in Time magazine. And you can about the medical establishments resultant mad scampering to make sure everyone knows this is experimental here.) Make no mistake: In spite of Dr. Maria News outrageous FDA-regulation-flaunting claims that this off-label drug use "has been found safe for mother and child," it aint been. New is a rogue pediatrician whom medical societies have been nudging (and sometimes yelling at) for years. Because she apparently wouldnt stop experimenting on these women and children without ethics oversight, in January I got called in to help by a few freaked-out clinicians. And I called in my colleagues to call out the feds. New just looks and sounds safe for mothers and children. Which is why shes ...
Amgen sent a "dear doctor" letter in January 2007 that highlighted results from a recent anemia of cancer trial, and warned doctors to consider use in that off-label indication with caution. Amgen advised the U.S. Food and Drug Administration (FDA) regarding the results of the DAHANCA 10 clinical trial. The DAHANCA 10 data monitoring committee found that three-year loco-regional cancer control in subjects treated with Aranesp was significantly worse than for those not receiving Aranesp (p=0.01). In response to these advisories, the FDA released a Public Health Advisory[18] on March 9, 2007, and a clinical alert[19] for doctors on February 16, 2007, about the use of erythropoeisis-stimulating agents (ESAs) such as epogen and darbepoetin. The advisory recommended caution in using these agents in cancer patients receiving chemotherapy or off chemotherapy, and indicated a lack of clinical evidence to support improvements in quality of life or transfusion requirements in these settings. In addition, ...
In this case, a question has been raised about using luteinizing hormone releasing hormone (LHRH) agonists to reduce sexual behavior. LHRH agonists are typically used for the suppression of centrally mediated precocious puberty, defined as puberty occurring before 9 years of age in a male. They are administered via monthly or 3 monthly injections and are also available as a 1 year depot implant. LHRH agonists, such as leuprolide and triptorelin injections, have been used for the court-ordered treatment of adult paraphilia (off-label indication).1,2 Use of leuprolide in an adult autistic male living in a group home was reportedly successful in reducing inappropriate behaviors and allowing him to continue to live in the community.3 Treatment measures, including sexual education and the antiandrogen flutamide, had been ineffective, resulting in temporary police custody for public sexual behaviors toward other people.3 Despite these reports, it is unclear if pubertal suppression for inappropriate ...
A high-dose combination of these supplements lowered the risk for advanced stages by 25%, according to the study, which was sponsored by the National Eye Institute. Zeaxanthin, a carotenoid found in spinach and greens, also helps. The wet form of AMD, the less common form, can also be treated with laser therapy or medicine. Three medicines that are injected into the eye have been approved by the FDA to slow or block the growth of new blood vessels in wet AMD, thus preserving sight. Pegaptanib was approved in 2004, ranibizumab was approved in 2006, and aflibercept was approved in 2013. Bevacizumab is a fourth medicine that is commonly used. It is similar in structure to ranibizumab, and is also injected in the eye. Bevacizumab was approved by the FDA in 2004 for cancer treatment. It is used off-label to treat wet AMD ...
Background and ObjectivesAlcohol use disorders (AUDs) are an important cause of morbidity and mortality. Despite the NIAAAs recommendations that medications be considered for patients with alcohol dependence, the mainstay of treatment has been counseling. We designed a survey to assess the treatment practices of Psychiatrists and Family Medicine (FM) physicians, in an effort to identify barriers to the use of pharmacotherapy and develop strategies to increase physician knowledge and utilization of these medications.MethodsAn anonymous online survey was sent to FM physicians and Psychiatrists nationwide. The survey collected demographic information and assessed prescription of medications in treating AUDs, including FDA-approved medications and other medications used off-label for this purpose. We also examined factors that would lead to an increase in AUDs pharmacotherapy.ResultsA total of 491 surveys were completed, with 475 responses included in the final analyses. 45.5% of participants were
The drug has also been used off-label to treat the symptoms of menopause. Serious and life-threatening Effexor side effects have also been observed. Wyeth Pharmaceuticals, the drugs manufacturer, was acquired. Tags: hip, stomach, weight, effexor, gain. Effexor xr side effects weight loss Depression, Gastrointestinal. ...
This eMedTV article describes some alternatives to Concerta, such as other medications and lifestyle changes. This page also outlines some specific stimulant and non-stimulant medicines, and lists some drugs that are used off-label to treat ADHD.
So when we did make it to the RE, we had a talk through all of our results- and they were all fantastic (phew). Then we got into treatment plan discussion. There was a RE in training there with my doc who had participated in a randomized, doubleblind, clinical trial of clomid vs femera. Femera (letrozole) is used off-label for infertility (it is actually a breast cancer drug). They did a study in women with PCOS and showed that femera resulted in more ovulations, pregnancies and live births. There was no statistical differences in pregnancy loss, fetal anomalies or multiples rates. There were fewer side effects on femera reported. ...
The Company reserves the right to modify the Dosing and Frequency Requirements listed in this Policy to ensure consistency with the most recently published recommendations for the use of IVIG and SCIG. Changes to these guidelines are based on a consensus of information obtained from resources such as, but not limited to: the US Food and Drug Administration (FDA), drug manufacturers guidelines, Company-recognized authoritative pharmacology compendia, or published peer-reviewed clinical research. The professional provider must supply supporting documentation (ie, published peer-reviewed literature) in order to request coverage for an amount of IVIG and SCIG outside of the Dosing and Frequency Requirements listed in this policy. For a list of Company-recognized pharmacology compendia and criteria for peer-reviewed clinical research, view our policy on off-label coverage for prescription drugs and biologics. ...
The Company reserves the right to modify the Dosing and Frequency Requirements listed in this Policy to ensure consistency with the most recently published recommendations for the use of rituximab infusion or related biosimilars, or rituximab/hyaluronidase human for subcutaneous injection (Rituxan Hycela ). Changes to these guidelines are based on a consensus of information obtained from resources such as, but not limited to: the US Food and Drug Administration (FDA); Company-recognized authoritative pharmacology compendia; or published peer-reviewed clinical research. The professional provider must supply supporting documentation (i.e., published peer-reviewed literature) in order to request coverage for an amount of rituximab infusion or related biosimilars, or rituximab/hyaluronidase human for subcutaneous injection (Rituxan Hycela ) outside of the Dosing and Frequency Requirements listed in this Policy. For a list of Company-recognized pharmacology compendia, view our policy on off-label ...
FW: Im glad you asked about that because its important to reflect on the challenges AtriCure faces, as well as the opportunities. Historically, for a couple of reasons, the company was not able to optimally train and educate doctors about its atrial fibrillation treatment. Cardiac surgeons got excited about this approach to AF in the days before AtriCure became public in August 2005. Then the company faced a very challenging period from 2008 to 2010, when the Department of Justice (DOJ) and the U.S. Food and Drug Administration (FDA) stepped up enforcement on off-label promotion of medical products and drugs for all healthcare companies. Unfortunately, AtriCure was one of the first companies to feel the ramifications of this stepped-up enforcement. They werent doing anything terrible, and their products were approved, but approved for general approaches to cardiac ablating procedures, rather than for specific targeted procedures, and not specifically for atrial fibrillation use. And so again ...
ScienceDaily (2008-11-26) -- Physicians and policy-makers know that drugs are frequently prescribed to treat certain diseases despite a lack of FDA approval, a practice known as off-label prescribing. Now researchers have developed a list of 14 widely prescribed medications most urgently in need of additional study to determine how effective and safe they are for their off-label uses. Antidepressants and antipsychotics are the most prominent classes of drugs on the list. ... , read full article ...
Off-label use is the practice of prescribing drugs for a purpose outside the scope of the drugs approved label, most often concerning the drugs indication. In the United States, the Food and Drug Administration (FDA) requires numerous clinical trials to prove a drugs safety and efficacy in treating a given disease or condition. If satisfied that the drug is safe and effective, the drugs manufacturer and the FDA agree on specific language describing dosage, route and other information to be included on the drugs label. More detail is included in the drugs package insert. 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. It is entirely legal in the United States and in many other countries to use drugs off-label ...
A shareholder lawsuit alleging Medtronic Inc. illegally promoted the off-label use of its Infuse bone growth product has been granted class action status by U.S. District Judge Paul Magnuson of Minnesota. According to a report from Law360.com, the Medtronic Infuse off-label promotion lawsuit was filed by several institutional investors on ... Read More. ...
A shareholder lawsuit alleging Medtronic Inc. illegally promoted the off-label use of its Infuse bone growth product has been granted class action status by U.S. District Judge Paul Magnuson of Minnesota. According to a report from Law360.com, the Medtronic Infuse off-label promotion lawsuit was filed by several institutional investors on ... Read More. ...
In contrast, 94 percent of multinational companies single drug formulations were CDSCO-approved, and over 70 percent had UK or US regulatory approval.. Lead author Dr Patricia McGettigan from Queen Mary said: "Selling unapproved, unscrutinized antibiotics undermines measures in India to control antimicrobial resistance. Multinational companies should explain the sale of products in India that did not have the approval of their own national regulators and, in many cases, did not even have the approval of the Indian regulator.". The researchers argue that changes needed to achieve the World Health Organizations (WHO) vision of good use of antibiotics include banning the sale of unapproved FDC antibiotics and enforcing existing regulations to prevent unapproved and illegal drugs reaching the market.. Improved access to health care to reduce non-prescription sales is also needed, alongside research to understand why doctors complicate problems by prescribing unapproved antibiotics.. ...
A new study in this issue of Diabetes (p. 3232) indicates that atypical antipsychotic (AAP) medications have a direct impact on diverse aspects of glucose regulation, and that these effects occur independently of weight gain. In recent years, a significant increase in the prescribing of AAP medications has been accompanied by a persistent observation that some of these drugs increase the risk of obesity and type 2 diabetes. A basic question that has continued to elude investigators is whether the weight gain and increased diabetes that are often observed among patients using AAP medications are part of the natural history of the disease processes for which these medications are prescribed or if these unfavorable side effects result from the medications themselves. This question has potentially widespread implications because of the large number of individuals who use these agents as well as increasing off-label use in pediatric and elderly populations. Although previous studies have attempted to ...
Bevacizumab (Avastin). Bascom Palmer Eye Institutes retina specialist Philip Rosenfeld, M.D., Ph.D. pioneered the off-label use of Avastin to treat the wet form of AMD. Now used by retina specialists throughout the world for its effectiveness and low cost compared with other treatments, Avastin was the first effective treatment in clinical practice that had the potential not only to stop further deterioration in vision from wet AMD, but bring about significant improvement in vision for these patients. Ranibizumab (Lucentis). Bascom Palmer Eye Institutes retina specialist Philip Rosenfeld, M.D., Ph.D. pioneered the use of Lucentis as well. In June 2006, the FDA approved Lucentis for the treatment of the wet form of AMD. Lucentis and Avastin are both manufactured by Genentech, Inc. and both drugs are derived from the same monoclonal antibody against VEGF and virtually perform the same function. Lucentis was engineered specifically for the eye and tested in rigorous Phase III trials. Like ...
The US Food and Drug Administration (FDA) launched a new app called CURE ID that allows health care professionals around the world to report novel uses of existing drugs to treat difficult-to-treat infectious diseases.. "The CURE ID application focuses on drugs for infectious diseases lacking adequate treatments, including neglected tropical diseases, emerging infectious threats and infectious caused by antimicrobial-resistant organisms," said FDA Principal Deputy Commissioner Amy Abernethy.. By reporting clinical outcomes to a central repository, Abernethy said it will be quicker and easier to identify promising off-label uses for already approved drugs that could eventually lead to new approved indications for those products.. "Our hope is that this app will serve as a connector among major treatment centers, academics, private practitioners, government facilities and other health care professionals from around the world and ultimately get treatments to patients faster," Abernethy said.. The ...
From drug dosing information to specialty patient populations and off-label uses, Micromedex® Medication Management provides reference tools and resources.
A federal appeals court has agreed to hear oral arguments about whether the First Amendment protects a sales reps ability to share information, indirectly, about off-label uses of a drug.
This eMedTV article explains why alogliptin and metformin is used to treat type 2 diabetes by describing the drugs effects in the body. It also addresses the issue of whether children can take this medication, as well as possible off-label uses.
This eMedTV article explains why pioglitazone and metformin XR is used to treat type 2 diabetes by describing the drugs effects in the body. It also addresses the issue of whether children can take this medication, as well as possible off-label uses.
Adults and children as young as four years old may use canakinumab to treat certain inflammatory conditions. This eMedTV page looks at the conditions this prescription drug is approved to treat and discusses whether there are off-label uses.
This selection from the eMedTV library explains why saxagliptin/metformin ER is used for type 2 diabetes in adults. It describes how this combination drug works, addresses possible off-label uses, and whether children can take it.
Allergan, the maker of the popular anti-wrinkle treatment Botox, has agreed to pay $600 million to settle a probe into illegal marketing for so-called off-label uses.
You know that Nasarel is used to treat allergies, but do you know how the drug works? In this eMedTV segment, we talk about the effects of Nasarel within the body. We also look at pediatric and off-label uses for this nasal spray.
Includes Modafinil indications, dosage/administration, pharmacology, mechanism/onset/duration of action, half-life, dosage forms, interactions, warnings, adverse reactions, off-label uses and more.
... generally include high blood pressure control and diabetic nephropathy treatment. This part of the eMedTV library describes these uses in more detail, explains how the medication works, and discusses off-label uses.
I have nothing to declare No off-label use of medications will be discussed Use of brand names and images is for illustration only, no endorsement is implied
25mg & 100mg injections. Commissioner: NHS England - Only when used in line with a current chemotherapy protocol from the North of England Cancer Network in line with the appropriate Network Site Specific Groups clinical guidelines or chemotherapy algorithm or NICE TA216.. When used for the treatment of low grade lymphomas, mantle cell NHL or relapsed multiple myeloma only when funded through the Cancer Drugs Fund.. MHRA Drug Safety Update (July 2017): Bendamustine (Levact): increased mortality observed in recent clinical studies in off-label use; monitor for opportunistic infections, hepatitis B reactivation. ...
Instead of encouraging the free flow of data, research and results, the FDA is trying to muzzle it - especially when the exchange involves drugmakers truthfully discussing off-label uses.
As this eMedTV Web page explains, aztreonam injection is used to treat infections caused by certain bacteria. The drug also has off-label uses, which are listed in the article. This resource also describes how the drug works.
This eMedTV segment explains why Nitrolingual can be used to both treat and prevent angina attacks -- at least on a short-term basis. This page also explains how this medicine works and discusses its use in children, as well as off-label uses.
In the last decade, rehabilitators have reported an increase required 21 days). Doxycycline is the antibiotic of choice for in the number of squirrels in rehabilitation dying dogs and cats and may be used in rabbits, squirrels, and unexpectedly and suddenly with few symptoms and no other rodents. Nebulizers were also used for some cases. obvious causes such as trauma or aspiration. Bordetel a has Since antibiotic treatment often disrupts gut flora, concurrent been confirmed by lab tests in some cases and administration of probiotics may be needed. rehabilitators believed it was responsible for more fatalities. Quickly identifying and treating this serious and contagious A few rehabilitators and veterinarians have treated respiratory condition improves the animals chance of Bordetel a infections in rodents with Nuflor, a next recovery and decreases spread of the infection. generation Chloramphenicol (antibiotic) approved for use with livestock. Nuflor is an off-label use for non-livestock ...
As this eMedTV page explains, Uroxatral uses generally include the treatment of an enlarged prostate (BPH). This page discusses how Uroxatral works and describes possible off-label uses of the medicine, such as treating urinary retention in women.
Occasionally (when excessively high temperatures made me feel ill), my hands & feet on the left side of my body would swell, causing "sausage-fingers & sausage-toes". The reason why only the left side of my body was affected is because the heart pumps more to the left than to the right (according to my GP). One solution to this problem is to stop the heart from pumping too much when feeling ill by taking a β1 receptor antagonist (a.k.a. beta blocker) e.g. Atenolol. As this is an off-label use of Atenolol, I ordered them on-line ...
Visken is approved to treat high blood pressure. This article from the eMedTV Web site discusses the uses of Visken in more detail (including possible off-label uses), describes how the drug works, and explains whether it can be used in children.
A doctor may prescribe Vibramycin to treat or prevent a variety of bacterial infections. This eMedTV segment takes a closer look at the uses of Vibramycin, including possible off-label uses, its use in children, and how the antibiotic works.
... As this segment of the eMedTV library explains, Biocef is commonly used to treat various bacterial infections and prevent bacterial endocarditis. Off-label uses and uses for the drug in children are also described.
Reclast, a bisphosphonate, is used to treat Pagets disease of the bone and osteoporosis. This segment of the eMedTV archives explains Reclast uses in detail, discussing off-label uses for the drug as well as whether it should be given to children.
Studies are showing a possible link between the off-label use of Zofran in pregnant women and birth defects including heart problems and cleft palate.
Progesterone capsules can be prescribed to women who have stopped having a period before menopause. This eMedTV Web page explains what progesterone capsules are used for, including other approved uses of the drug and possible off-label uses.
For some children, despite their parents best efforts, sleep doesnt come easily. If your childs attempt to fall into a restful slumber results in a struggle each night, he may suffer from a sleep disorder. While the FDA does not recommend any sleeping medications for children, some doctors opt to use sleep-aid medicine in an "off-label" fashion. When a doctor uses a drug "off-label," he is using the drug in a way that it wasnt originally intended. These "off-label" sleep aids likely pose little risk to your child and, with a doctors guidance, may prove to be the answer to his struggles.. ...
Credit Management Solutions are currently seeking a Business/Marketing Intern to help with various initiatives to retain and expand their customer base. The successful applicant will learn about the company and products and participate in projects such as Customer Relationship Management (CRM), Search Engine Optimization (SEO) and other internal company projects ...
Last April, Tarik Logan suffered debilitating headaches from the fumes of a toxic glue he had to use at the plant. The searing pain became so unbearable he couldnt work, and it plagued him for weeks.. But Logans inhalation injury, as it was diagnosed, never made it onto the official injury logs that state and federal law requires companies to keep. Neither did reports from other factory workers of sprains, strains and repetitive stress injuries from piecing together Teslas sleek cars.. Instead, company officials labeled the injuries personal medical issues or minor incidents requiring only first aid, according to internal company records obtained by Reveal.. Undercounting injuries is one symptom of a more fundamental problem at Tesla. The company has put its manufacturing of electric cars above safety concerns, according to five former members of its environment, health and safety team who left the company last year. That, they said, has put workers unnecessarily in harms way.. At one point, ...
Four weeks and almost $900,000 into its "bullshit" Indiegogo campaign, Moscow-based Healbe has finally made good on one of its promises and released a new set of product FAQs.. One problem: the new FAQs simply add to the number of questions around the companys miracle calorie counting wristband, rather than answering any. Promised patent information and internal company research is completely skipped over, and instead the company doubles down on some of its already debunked science, walks back on others and provides a garbled, confusing company history that now centers around - hold your breath - a Russian science fiction author.. At this point its unclear even whether Healbe believes its own claims or is just playing some grand million dollar prank on its customers, and the media. A practical joke in which Indiegogo is unforgivably, almost criminally complicit.. As with all the companys previous claims, Pando asked doctors for their comments on the new FAQs.. On how the GoBe device ...
Have you ever wanted to integrate your COMSOL® software apps with external data files? These files can contain material properties, geometric dimensions, or other model inputs, and such data can derive from internal company standards or be provided by a vendor. Built-in methods in the Application Builder simplify reading from these files and displaying options read. To show this procedure, we will build an app that populates a combo box with material properties from a comma-separated values (CSV) file.. Read More ...
Appearing in this issue of Anesthesia & Analgesia are 2 clinical manuscripts reporting hospital audits of the use of sedative, analgesic, and anesthetic medications in children. The authors of these reports used robust databases to examine pediatric pharmacology prescribing in the inpatient environment. Although drug labeling for use in the pediatric population may be improving, the results from these investigations suggest a substantial use of agents "off-label" in children. This practice is quite common and considered superior to denying children the benefits of these agents in the practice of anesthesiology.. In their report, Lasky et al. reveal "the prevalence of use of specific medications among hospitalized children in 2008."1 Their dataset includes greater than 875,000 hospitalized children admitted to 423 hospitals that participated. The analysis included ,12 million drug administrations to children from birth to age 18 years. They analyze and report the frequency of use of specific ...
Gabapentin is a drug that was approved by the FDA in 1993 as an adjunct treatment for epileptic seizures. It has since attained approval for the treatmen
A French move to allow the use ofRoches cancer drug Avastin as a cheap alternative eyetreatment, even though it is not designed for this purpose, wascriticised by the pharmaceutical industry on Wednesday.
Burkitts ifg.akef.sincerebeauty.nl.eqm.ed infective, combination [URL=https://operatingpartner.com/2017/09/five-questions-dick-boyce-former-partner-tpg/?unapproved=398&moderation-hash=b9f062fd27ce77355cc5e6929302e83e#comment-398 - documentation[/URL - <a href="https://operatingpartner.com/2017/09/five-questions-dick-boyce-former-partner-tpg/?unapproved=398&moderation-hash=b9f062fd27ce77355cc5e6929302e83e#comment-398">documentation</a> https://operatingpartner.com/2017/09/five-questions-dick-boyce-former-partner-tpg/?unapproved=398&moderation-hash=b9f062fd27ce77355cc5e6929302e83e#comment-398 implement [URL=https://armorguys.com/todays-work-environment-requires-new-ppe-technologies/?unapproved=986&moderation-hash=abf45272fe3906d91953e09f785174b6#comment-986 - nifedipine[/URL - <a href="https://armorguys.com/todays-work-environment-requires-new-ppe-technologies/?unapproved=986&moderation-hash=abf45272fe3906d91953e09f785174b6#comment-986">fissure</a> ...