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https://www.readbyqxmd.com/read/28633634/the-development-and-appraisal-of-a-tool-designed-to-find-patients-harmed-by-falsely-labelled-falsified-counterfeit-medicines
#1
Marija Anđelković, Einar Björnsson, Virgilio De Bono, Nenad Dikić, Katleen Devue, Daniel Ferlin, Miroslav Hanževački, Freyja Jónsdóttir, Mkrtich Shakaryan, Sabine Walser
BACKGROUND: Falsely labelled, falsified (counterfeit) medicines (FFCm's) are produced or distributed illegally and can harm patients. Although the occurrence of FFCm's is increasing in Europe, harm is rarely reported. The European Directorate for the Quality of Medicines & Health-Care (EDQM) has therefore coordinated the development and validation of a screening tool. METHODS: The tool consists of a questionnaire referring to a watch-list of FFCm's identified in Europe, including symptoms of their use and individual risk factors, and a scoring form...
June 20, 2017: BMC Health Services Research
https://www.readbyqxmd.com/read/28631870/thalamic-deep-brain-stimulation-for-neuropathic-pain-efficacy-at-three-years-follow-up
#2
Vasco Abreu, Rui Vaz, Virgínia Rebelo, Maria José Rosas, Clara Chamadoira, Martin J Gillies, Tipu Z Aziz, Erlick A C Pereira
OBJECT: Chronic neuropathic pain is estimated to affect 3-4.5% of the worldwide population, posing a serious burden to society. Deep Brain Stimulation (DBS) is already established for movement disorders and also used to treat some "off-label" conditions. However, DBS for the treatment of chronic, drug refractory, neuropathic pain, has shown variable outcomes with few studies performed in the last decade. Thus, this procedure has consensus approval in parts of Europe but not the USA. This study prospectively evaluated the efficacy at three years of DBS for neuropathic pain...
June 20, 2017: Neuromodulation: Journal of the International Neuromodulation Society
https://www.readbyqxmd.com/read/28631809/anabolic-steroids-for-treating-pressure-ulcers
#3
REVIEW
Cho Naing, Maxine A Whittaker
BACKGROUND: Pressure ulcers, also known as bed sores, pressure sores or decubitus ulcers develop as a result of a localised injury to the skin or underlying tissue, or both. The ulcers usually arise over a bony prominence, and are recognised as a common medical problem affecting people confined to a bed or wheelchair for long periods of time. Anabolic steroids are used as off-label drugs (drugs which are used without regulatory approval) and have been used as adjuvants to usual treatment with dressings, debridement, nutritional supplements, systemic antibiotics and antiseptics, which are considered to be supportive in healing of pressure ulcers...
June 20, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28628686/off-face-usage-of-poly-l-lactic-acid-for-body-rejuvenation
#4
Ahmad Jabbar, Suleima Arruda, Neil Sadick
<p>Injectable soft-tissue augmentation agents have become popular alternatives to surgical procedures for the aging face and body. In contrast to temporary, space-occupying replacement fillers such as collagen-based and hyaluronic acid products, poly-l-lactic acid (PLLA) has been demonstrated to gradually promotes deposition of collagen via a biostimulatory response, with therapeutic effects lasting approximately two years. In 2004, the FDA approved its use for rejuvenation of facial contours secondary to lipoatrophy associated with antiretroviral therapy for HIV infection...
May 1, 2017: Journal of Drugs in Dermatology: JDD
https://www.readbyqxmd.com/read/28628405/further-implications-of-off-label-use-of-acetazolamide-in-the-management-of-moyamoya-disease-in-japan
#5
Shunji Mugikura, Miki Fujimura, Shoki Takahashi, Kei Takase
No abstract text is available yet for this article.
July 2017: Radiology
https://www.readbyqxmd.com/read/28627939/off-label-prescribing-for-children-with-chronic-diseases-in-nigeria-findings-and-implications
#6
Kazeem Adeola Oshikoya, Ibrahim Adekunle Oreagba, Brian Godman, Joseph Fadare, Samuel Orubu, Amos Massele, Idowu Odunayo Senbanjo
BACKGROUND AND AIMS: Prescribing medicines in an off-label manner for children with chronic conditions is sparsely documented, even more so among developing countries. This needs addressing. The objective was to investigate the extent of this prescribing among children with epilepsy, asthma, and sickle cell anaemia in Nigeria. METHODS: Prescriptions for children ≤16 years documented in their case files that attended paediatric clinics in Lagos, Nigeria, for these three conditions between January and October 2015, were reviewed retrospectively to extract data on the medicines prescribed...
June 19, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28627133/mesocorticolimbic-hemodynamic-response-in-parkinson-s-disease-patients-with-compulsive-behaviors
#7
Daniel O Claassen, Adam J Stark, Charis A Spears, Kalen J Petersen, Nelleke C van Wouwe, Robert M Kessler, David H Zald, Manus J Donahue
BACKGROUND: PD patients treated with dopamine therapy can develop maladaptive impulsive and compulsive behaviors, manifesting as repetitive participation in reward-driven activities. This behavioral phenotype implicates aberrant mesocorticolimbic network function, a concept supported by past literature. However, no study has investigated the acute hemodynamic response to dopamine agonists in this subpopulation. OBJECTIVES: We tested the hypothesis that dopamine agonists differentially alter mesocortical and mesolimbic network activity in patients with impulsive-compulsive behaviors...
June 19, 2017: Movement Disorders: Official Journal of the Movement Disorder Society
https://www.readbyqxmd.com/read/28625834/association-between-natural-killer-cell-activity-and-colorectal-cancer-in-high-risk-subjects-undergoing-colonoscopy
#8
G Jobin, R Rodriguez-Suarez, K Betito
BACKGROUND & AIMS: Low activity of natural killer (NK) cells has been associated with increased risk of cancer and has been reported in patients with colorectal cancer (CRC). Activity of NK cells can be measured in a small volume of whole blood by a commercially available test. We investigated whether this test could be used to identify patients with CRC, using findings from colonoscopy as a reference standard. METHODS: We performed an open-label, prospective, cross-sectional study of 872 high-risk subjects (more than 40 years old) screened for CRC by colonoscopy at a university hospital in Montreal, Canada from October 2014 through January 2016...
June 15, 2017: Gastroenterology
https://www.readbyqxmd.com/read/28625369/rationale-and-design-of-the-hunting-for-the-off-target-properties-of-ticagrelor-on-endothelial-function-and-other-circulating-biomarkers-in-humans-hi-tech-trial
#9
Sara Ariotti, Maarten van Leeuwen, Salvatore Brugaletta, Sergio Leonardi, Kristiaan Martijn Akkerhuis, Emrush Rexhaj, Gladys Janssens, Luis Ortega-Paz, Diego Rizzotti, Jan C van den Berge, Dierik Heg, Gloria Francolini, Stephan Windecker, Marco Valgimigli
BACKGROUND: Among the 3 approved oral P2Y12 inhibitors for the treatment for patients with acute coronary syndrome (ACS), ticagrelor, but not prasugrel or clopidogrel, has been associated with off-target properties, such as improved endothelial-dependent vasomotion and increased adenosine plasma levels. METHODS: The HI-TECH study (NCT02587260) is a multinational, randomized, open-label, crossover study with a Latin squares design, conducted at 5 European sites, in which patients free from recurrent ischemic or bleeding events ≥30 days after a qualifying ACS were allocated to sequentially receive a 30 ± 5-day treatment with prasugrel, clopidogrel, and ticagrelor in random order...
July 2017: American Heart Journal
https://www.readbyqxmd.com/read/28625145/clomiphene-for-the-treatment-of-male-infertility-a-case-report-of-mood-change
#10
Marine Aussedat, Jennifer Jean-Louis, Orchidée Djahangirian, Marie-Sophie Brochet
BACKGROUND: Clomiphene is normally used in women with ovulatory dysfunction. In men, it is used off label in some cases of infertility. Psychological adverse effects are reported in women but very few in men. CASE: A 34 year-old man treated with clomiphene for oligoteratospermia presented anxiety, decreased appetite, and depressed mood making him unable to function properly at work, five days after initiation of therapy. Symptoms required reduction followed by discontinuation of treatment four days later because of absence of improvement...
June 15, 2017: Current Drug Safety
https://www.readbyqxmd.com/read/28623406/nucleoside-analogue-2-c-methylcytidine-inhibits-hepatitis-e-virus-replication-but-antagonizes-ribavirin
#11
Changbo Qu, Lei Xu, Yuebang Yin, Maikel P Peppelenbosch, Qiuwei Pan, Wenshi Wang
Hepatitis E virus (HEV) infection has emerged as a global health issue, but no approved medication is available. The nucleoside analogue 2'-C-methylcytidine (2CMC), a viral polymerase inhibitor, has been shown to inhibit infection with a variety of viruses, including hepatitis C virus (HCV). Here, we report that 2CMC significantly inhibits the replication of HEV in a subgenomic replication model and in a system using a full-length infectious virus. Importantly, long-term treatment with 2CMC did not result in a loss of antiviral potency, indicating a high barrier to drug resistance development...
June 16, 2017: Archives of Virology
https://www.readbyqxmd.com/read/28623386/the-antipsychotic-agent-quetiapine-is-increasingly-not-used-as-such-dispensed-prescriptions-in-norway-2004-2015
#12
Pål Gjerden, Jørgen G Bramness, Ingunn Fride Tvete, Lars Slørdal
PURPOSE: The antipsychotic agent quetiapine was introduced in Norway in 2003. We have assessed changes in dispensed prescriptions, including dosing, of quetiapine in Norway from 2004 to 2015. METHODS: Data on the sales of antipsychotics and antidepressants were drawn from the Norwegian Prescription Database. A total of 47,474 outpatients filled 195,622 prescriptions of quetiapine. Reimbursement codes, use of antipsychotics or antidepressants 12 months prior to the first prescription of quetiapine and estimated mean volume used measured as defined daily doses (DDDs) per day were used as proxies for diagnoses...
June 16, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28622741/characterization-of-guideline-evidence-for-off-label-medication-use-in-the-intensive-care-unit
#13
Bethany R Shoulders, Pamela L Smithburger, Stephanie Tchen, Mitchell Buckley, Ishaq Lat, Sandra L Kane-Gill
BACKGROUND: Non-Food and Drug Administration (FDA) or off-label medication prescribing occurs commonly in the intensive care unit (ICU). Off-label medication use creates a concern for untoward adverse effects; however, this worry may be alleviated by supportive literature. OBJECTIVE: To evaluate the evidence behind off-label medication use by determining the presence of guideline support and compare graded recommendations to an online tertiary resource, DRUGDEX...
July 2017: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/28622667/netvlad-cnn-architecture-for-weakly-supervised-place-recognition
#14
Relja Arandjelovic, Petr Gronat, Akihiko Torii, Tomas Pajdla, Josef Sivic
We tackle the problem of large scale visual place recognition, where the task is to quickly and accurately recognize the location of a given query photograph. We present the following four principal contributions. First, we develop a convolutional neural network (CNN) architecture that is trainable in an end-to-end manner directly for the place recognition task. The main component of this architecture, NetVLAD, is a new generalized VLAD layer, inspired by the "Vector of Locally Aggregated Descriptors" image representation commonly used in image retrieval...
June 1, 2017: IEEE Transactions on Pattern Analysis and Machine Intelligence
https://www.readbyqxmd.com/read/28620705/topical-bevacizumab-treatment-in-aniridia
#15
Ruth Lapid-Gortzak, Nathalie T Y Santana, Carla P Nieuwendaal, Maarten P Mourits, Ivanka J E van der Meulen
PURPOSE: To report the results of long-term topical treatment with bevacizumab (Avastin) 5 mg/mL eyedrops in a case of aniridia-related neovacularization of the cornea. METHODS: Interventional case report. A female patient with aniridia had a decrease in the best corrected visual acuity from 0.32 to 0.02 in the OS over the course of 4 years, secondary to central corneal neovascularization and epithelial breakdown. Vision in the OD was 0.2. In 2008, at age 28, a shared decision was made to start off-label treatment with bevacizumab eyedrops 0...
June 15, 2017: International Ophthalmology
https://www.readbyqxmd.com/read/28620500/lugol-s-solution-induced-painless-thyroiditis
#16
Ji Wei Yang, Jacques How
Lugol's solution is usually employed for a limited period for thyroidectomy preparation in patients with Graves' disease and for the control of severe thyrotoxicosis and thyroid storm. We describe a rare case of Lugol's solution-induced painless thyroiditis. In November 2014, a 59-year-old woman was prescribed Lugol's solution four drops per day for the alleviation of menopausal symptoms. She was referred to our clinic in June 2015 for fatigue, hair loss, and a 20-lb weight loss without thyroid pain or discomfort...
2017: Endocrinology, Diabetes & Metabolism Case Reports
https://www.readbyqxmd.com/read/28618239/extent-and-risks-of-antipsychotic-off-label-use-in-children-and-adolescents-in-germany-between-2004-and-2011
#17
Carsten Schröder, Michael Dörks, Bianca Kollhorst, Tilo Blenk, Ralf W Dittmann, Edeltraut Garbe, Oliver Riedel
OBJECTIVE: Only little is known about antipsychotic (AP) off-label use (OLU) in pediatric populations. It was the aim of this study to examine the frequency as well as the risks of off-label AP use in underaged patients. METHODS: To calculate the frequency of off-label AP prescriptions for the years 2004-2011, we used claims data of more than two million minors aged 0-17 years. Off-label prescriptions were analyzed with regard to type of OLU, physician specialty, and underlying diagnoses...
June 15, 2017: Journal of Child and Adolescent Psychopharmacology
https://www.readbyqxmd.com/read/28618223/covalent-protein-labeling-and-improved-single-molecule-optical-properties-of-aqueous-cdse-cds-quantum-dots
#18
Sara M Wichner, Victor R Mann, Alexander S Powers, Maya A Segal, Mustafa Mir, Jigar N Bandaria, Mark A DeWitt, Xavier Darzacq, Ahmet Yildiz, Bruce E Cohen
Semiconductor quantum dots (QDs) have proven to be superior probes for single molecule imaging compared to organic or genetically encoded fluorophores, but they are limited by difficulties in protein targeting, their larger size and on-off blinking. Here, we report compact aqueous CdSe/CdS QDs with significantly improved bioconjugation efficiency and superior single-molecule optical properties. We have synthesized covalent protein labeling ligands (i.e., SNAP tags) that are optimized for nanoparticle use, and QDs functionalized with these ligands label SNAP-tagged proteins ~10-fold more efficiently than existing SNAP ligands...
June 15, 2017: ACS Nano
https://www.readbyqxmd.com/read/28617905/incidence-of-presumed-silicone-oil-droplets-in-the-vitreous-cavity-after-intravitreal-bevacizumab-injection-with-insulin-syringes
#19
Rahul N Khurana, Louis K Chang, Travis C Porco
Importance: Intravitreal bevacizumab is a frequently used antivascular endothelial growth factor medication in the United States, but its off-label use is associated with risks associated with the compounding preparation. Objective: To determine the incidence of presumed silicone oil droplets after intravitreal bevacizumab was prepared in insulin syringes by a compounding pharmacy. Design, Setting, and Participants: A retrospective review was conducted of 60 patients who experienced intravitreal silicone oil droplets in the eye after intravitreal bevacizumab injections from a single specialist practice from October 1, 2015, to November 30, 2016...
June 15, 2017: JAMA Ophthalmology
https://www.readbyqxmd.com/read/28616214/high-dose-hydroxocobalamin-for-vasoplegic-syndrome-causing-false-blood-leak-alarm
#20
Wisit Cheungpasitporn, John Hui, Kianoush B Kashani, Erica D Wittwer, Robert C Albright, John J Dillon
Blood leak alarms are important safety features in a hemodialysis machine to protect patients from loss of blood through a rupture in the dialyzer membrane (true alarms). A false blood leak alarm can be triggered by air bubbles or detector malfunction (such as deposits of grease or scale). Hydroxocobalamin is an injectable form of vitamin B12 approved by the US Food and Drug Administration for the treatment of confirmed or suspected cyanide toxicity. Due to observations of an increase in arterial pressure after high-dose hydroxocobalamin infusion for the treatment of acute cyanide poisoning, it has recently been reported as an off-label rescue treatment for post-cardiopulmonary bypass vasoplegic syndrome...
June 2017: Clinical Kidney Journal
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