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Adverse drug reactions

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https://www.readbyqxmd.com/read/29160839/inkjet-printing-of-drug-loaded-mesoporous-silica-nanoparticles-a-platform-for-drug-development
#1
Henrika Wickström, Ellen Hilgert, Johan O Nyman, Diti Desai, Didem Şen Karaman, Thomas de Beer, Niklas Sandler, Jessica M Rosenholm
Mesoporous silica nanoparticles (MSNs) have shown great potential in improving drug delivery of poorly water soluble (BCS class II, IV) and poorly permeable (BCS class III, IV) drugs, as well as facilitating successful delivery of unstable compounds. The nanoparticle technology would allow improved treatment by reducing adverse reactions of currently approved drugs and possibly reintroducing previously discarded compounds from the drug development pipeline. This study aims to highlight important aspects in mesoporous silica nanoparticle (MSN) ink formulation development for digital inkjet printing technology and to advice on choosing a method (2D/3D) for nanoparticle print deposit characterization...
November 21, 2017: Molecules: a Journal of Synthetic Chemistry and Natural Product Chemistry
https://www.readbyqxmd.com/read/29158717/adverse-drug-reactions-in-high-risk-pregnant-women-a-prospective-study
#2
Alfredo Dias de Oliveira-Filho, Antonio Emanuel Soares Vieira, Roberta Cruz da Silva, Sabrina Joany Felizardo Neves, Thiago Antonio Barros Gama, Ryane Vieira Lima, Wlisses Ramon Oliveira, Júlia Maria de Gonçalves Dias
Background: Because pregnant women are often excluded from clinical trials, there is still very limited information about the risk and safety of prescription drugs during pregnancy. Objective: We aimed to determine the prevalence of Adverse Drug Reactions (ADRs) in high-risk pregnant women after hospital admission. A prospective study was carried out in a teaching maternity hospital in Brazil during six months. Causality of ADRs was assessed through the Naranjo Algorithm and Korean Algorithm for ADR Causality Assessment...
November 2017: Saudi Pharmaceutical Journal: SPJ: the Official Publication of the Saudi Pharmaceutical Society
https://www.readbyqxmd.com/read/29158363/phase-i-pharmacokinetic-study-of-nivolumab-in-korean-patients-with-advanced-solid-tumors
#3
Keun-Wook Lee, Dae Ho Lee, Jin Hyoung Kang, Joon Oh Park, Se Hyun Kim, Yong Sang Hong, Seung Tae Kim, Do-Youn Oh, Yung-Jue Bang
LESSONS LEARNED: This pharmacokinetic study of nivolumab showed that there is little ethnic difference in the handling of nivolumab.Nivolumab was well tolerated in Korean patients. BACKGROUND: This phase I study of nivolumab, an anti-programmed cell death-1 (anti-PD-1) monoclonal antibody, investigated the pharmacokinetics and safety of nivolumab in Korean patients with advanced solid tumors. Findings were compared with results from Japan and the U.S. MATERIALS AND METHODS: In this two-part study, patients received a single dose of nivolumab (1, 3, and 10 mg/kg; ONO-4538-13) and were followed up for 3 weeks...
November 20, 2017: Oncologist
https://www.readbyqxmd.com/read/29157828/immune-related-and-adverse-drug-reactions-to-low-versus-high-initial-doses-of-viscum-album-l-in-cancer-patients
#4
Friedemann Schad, Anja Thronicke, Antje Merkle, Harald Matthes, Megan L Steele
BACKGROUND: Immune-related adverse drug reactions (ADRs) to immunotherapy agents have been associated with beneficial clinical outcomes in oncology. Viscum album L. (VA, European mistletoe) is frequently used as an immunomodulatory agent alongside conventional cancer treatment in Europe. VA has been associated with improved quality of life and a reduction in chemotherapy-related ADRs. Beneficial effects of VA are believed to be related to its immunomodulatory properties. Current guidelines recommend commencing with a low dose and increasing slowly overtime, however, off-label prescribing of high initial doses is common...
December 1, 2017: Phytomedicine: International Journal of Phytotherapy and Phytopharmacology
https://www.readbyqxmd.com/read/29157317/entomopathogenic-bacteria-photorhabdus-luminescens-as-drug-source-against-leishmania-amazonensis
#5
Ana Maria Antonello, Thaís Sartori, Ana Paula Folmer Correa, Adriano Brandelli, Ralf Heermann, Luiz Carlos Rodrigues Júnior, Alessandra Peres, Pedro Roosevelt Torres Romão, Onilda Santos Da Silva
Leishmaniasis is a widely spread and zoonotic disease with serious problems as low effectiveness of drugs, emergence of parasite resistance and severe adverse reactions. In recent years, considerable attention has been given to secondary metabolites produced by Photorhabdus luminescens, an entomopathogenic bacterium. Here, we assessed the leishmanicidal activity of P. luminescens culture fluids. Initially, promastigotes of Leishmania amazonensis were incubated with cell free conditioned medium of P. luminescens and parasite survival was monitored...
November 21, 2017: Parasitology
https://www.readbyqxmd.com/read/29157026/first-experiences-with-a-tool-to-measure-the-level-of-clinical-information-present-in-adverse-drug-reaction-reports
#6
Ingrid Oosterhuis, Leàn Rolfes, Corine Ekhart, Annemarie Muller-Hansma, Linda Härmark
BACKGROUND: To make a proper causality assessment of an adverse drug reaction (ADR) report, a certain level of clinical information is necessary. A tool was developed to measure the level of clinical information present in ADR reports. The aim of this study was to test the validity and reliability of the clinical documentation tool (ClinDoc) in an international setting. METHODS: The tool was developed by a panel of pharmacovigilance experts. It includes four domains: ADR, chronology of the ADR, suspected drug and patient characteristics...
November 20, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29155870/a-modified-delphi-study-to-determine-the-level-of-consensus-across-the-european-union-on-the-structures-processes-and-desired-outcomes-of-the-management-of-polypharmacy-in-older-people
#7
Derek Stewart, Kathrine Gibson-Smith, Katie MacLure, Alpana Mair, Albert Alonso, Carles Codina, Antonio Cittadini, Fernando Fernandez-Llimos, Glenda Fleming, Dimitra Gennimata, Ulrika Gillespie, Cathy Harrison, Ulrike Junius-Walker, Przemysław Kardas, Thomas Kempen, Moira Kinnear, Pawel Lewek, Joao Malva, Jennifer McIntosh, Claire Scullin, Birgitt Wiese
BACKGROUND: Inappropriate use of multiple medicines (inappropriate polypharmacy) is a major challenge in older people with consequences of increased prevalence and severity of adverse drug reactions and interactions, and reduced medicines adherence. The aim of this study was to determine the levels of consensus amongst key stakeholders in the European Union (EU) in relation to aspects of the management of polypharmacy in older people. METHODS: Forty-six statements were developed on aspects of healthcare structures, processes and desired outcomes, with consensus defined at ≥ 80% agreement...
2017: PloS One
https://www.readbyqxmd.com/read/29155440/severe-hypoglycemia-caused-by-lenalidomide
#8
Daniel J Przybylski, Ruemu Birhiray, David J Reeves
Lenalidomide is commonly used for multiple myeloma as either induction or maintenance therapy. The agent is associated with a host of adverse effects, but hypoglycemia has only been reported in one phase I trial in patients with solid tumors. We describe a 74-year-old woman who experienced grade 3 hypoglycemia (blood glucose level 35 mg/dL) likely related to lenalidomide. Her medical history was significant for refractory myeloma and type 2 diabetes mellitus. Lenalidomide was started as maintenance therapy following autologous bone marrow transplantation...
November 20, 2017: Pharmacotherapy
https://www.readbyqxmd.com/read/29155147/selective-and-membrane-permeable-small-molecule-inhibitors-of-nicotinamide-n-methyltransferase-reverse-high-fat-diet-induced-obesity-in-mice
#9
Harshini Neelakantan, Virginia Vance, Michael D Wetzel, Hua-Yu Leo Wang, Stanton F McHardy, Celeste C Finnerty, Jonathan D Hommel, Stanley J Watowich
There is a critical need for new mechanism-of-action drugs that reduce the burden of obesity and associated chronic metabolic comorbidities. A potentially novel target to treat obesity and type 2 diabetes is nicotinamide-N-methyltransferase (NNMT), a cytosolic enzyme with newly identified roles in cellular metabolism and energy homeostasis. To validate NNMT as an anti-obesity drug target, we investigated the permeability, selectivity, mechanistic, and physiological properties of a series of small molecule NNMT inhibitors...
November 15, 2017: Biochemical Pharmacology
https://www.readbyqxmd.com/read/29153952/surveillance-of-the-safety-and-efficacy-of-recombinant-human-soluble-thrombomodulin-in-patients-with-obstetrical-disseminated-intravascular-coagulation
#10
Takao Kobayashi, Masahiro Kajiki, Katsuhito Nihashi, Goichi Honda
BACKGROUND: Recombinant human soluble thrombomodulin (TM-α) has been shown to be useful in the treatment of disseminated intravascular coagulation (DIC) in a heparin-controlled study, and has been available for clinical use in Japan since 2008. However, use of TM-α for obstetrical DIC has not yet been established, so efficacy and safety were analyzed in 117 obstetrical DIC patients identified from post-marketing surveillance. MATERIALS AND METHODS: From June 2010 to March 2012, the cases of 117 patients with obstetrical DIC treated with TM-α were registered...
September 18, 2017: Thrombosis Research
https://www.readbyqxmd.com/read/29151835/opuntia-humifusa-modulates-morphological-changes-characteristic-of-asthma-via-il-4-and-il-13-in-an-asthma-murine-model
#11
Soon-Young Lee, Chun-Sik Bae, Young-Hoon Choi, Nam-Sook Seo, Chang-Su Na, Jin-Cheol Yoo, Seung Sik Cho, Dae-Hun Park
Asthma is a chronic pulmonary disease that affects an estimated 235 million people worldwide, but asthma drugs have many adverse effects. Opuntia humifusa (eastern prickly pear) has been used as a food and traditional medicine worldwide; however, its anti-asthmatic effects have not been reported. We evaluated O. humifusa as a potential therapeutic or preventive component of anti-asthmatic drugs. We divided ovalbumin-sensitized mice into the following groups: normal control, asthma-induced control, dexamethasone-treated group (positive control), 50 mg/kg O...
2017: Food & Nutrition Research
https://www.readbyqxmd.com/read/29151132/safety-of-intrathecal-route-focus-to-methylprednisolone-acetate-depo-medrol-use
#12
REVIEW
Joël Schlatter, David Nguyen, Michèle Zamy, Sofiane Kabiche, Jean-Eudes Fontan, Salvatore Cisternino
PURPOSE: Complications of the intrathecal route may cause potential toxicity related to the medical device and properties of the administered drug and/or excipient. A description of clinical and histological effects of polyethylene glycol and miripirium after Depo-Medrol injection, and the adverse reactions of particulate methylprednisolone acetate was conducted. The safety of the intrathecal route with excipients, label and off-label drugs is discussed. METHODS: A bibliographic search in Medline, Google, and Cochrane database from 1940 to June 2016 was performed...
November 18, 2017: European Spine Journal
https://www.readbyqxmd.com/read/29150704/evaluation-of-immune-mediated-idiosyncratic-drug-toxicity-using-chimeric-hla-transgenic-mice
#13
Takeshi Susukida, Shigeki Aoki, Kotaro Kogo, Sota Fujimori, Binbin Song, Cong Liu, Shuichi Sekine, Kousei Ito
Immune-mediated idiosyncratic drug toxicity (IDT) is a rare adverse drug reaction, potentially resulting in death. Although genome-wide association studies suggest that the occurrence of immune-mediated IDT is strongly associated with specific human leukocyte antigen (HLA) allotypes, these associations have not yet been prospectively demonstrated. In this study, we focused on HLA-B*57:01 and abacavir (ABC)-induced immune-mediated IDT, and constructed transgenic mice carrying chimeric HLA-B*57:01 (B*57:01-Tg) to determine if this in vivo model may be useful for evaluating immune-mediated IDT...
November 17, 2017: Archives of Toxicology
https://www.readbyqxmd.com/read/29150250/a-randomized-multicenter-double-blind-placebo-controlled-study-to-evaluate-the-efficacy-and-the-tolerability-of-a-triple-combination-of-amlodipine-losartan-rosuvastatin-in-patients-with-comorbid-essential-hypertension-and-hyperlipidemia
#14
Hae-Young Lee, Seok-Yeon Kim, Kee-Joon Choi, Byung-Su Yoo, Dong-Hun Cha, Hae Ok Jung, Dong-Ryeol Ryu, Joon Hyouk Choi, Kwang Je Lee, Tae Ho Park, Ju Hyeon Oh, Sang Min Kim, Ji-Yong Choi, Kye Hun Kim, Jaemin Shim, Woo-Shik Kim, Si-Wan Choi, Dae-Gyun Park, Pil-Sang Song, Taek-Jong Hong, Moo-Yong Rhee, Seung-Woon Rha, Seung Woo Park
PURPOSE: The objective of this study was to evaluate the efficacy and tolerability of a triple combination of amlodipine/losartan/rosuvastatin in patients with hypertension and hypercholesterolemia. METHODS: A randomized, multicenter, double-blind, placebo-controlled study was conducted. Eligible patients with hypertension and a sitting diastolic blood pressure (SiDBP) of >90 mm Hg and LDL-C levels <250mg/dL were screened. After a 4-week run-in period with therapeutic lifestyle changes and losartan potassium 100mg once daily, patients who met both blood pressure criteria (80 mm Hg ≤ SiDBP < 110 mm Hg) and the LDL-C level criteria (defined in the National Cholesterol Education Program Adult Treatment Panel III cardiovascular risk categories) were randomized to 1 of 3 groups and treated once daily for 8 weeks: losartan potassium 100mg + rosuvastatin 20mg treatment (L/R 100/20) group, amlodipine camsylate 5mg + losartan potassium 100mg treatment (A/L 5/100) group, and amlodipine 5mg+ losartan potassium 100mg + rosuvastatin 20mg (A/L/R 5/100/20) group...
November 14, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/29149926/drug-induced-gastrointestinal-and-hepatic-disease-associated-with-biologics-and-nonbiologic-disease-modifying-antirheumatic-drugs
#15
REVIEW
Patrick R Wood, Liron Caplan
A variety of gastrointestinal adverse drug reactions are seen in nearly all conventional antirheumatic medications, ranging from nausea to life-threatening drug-induced liver injury. Rheumatologists should be particularly familiar with hepatotoxicity associated with long-term methotrexate use, and the range of unique hepatic, biliary, and pancreatic manifestations associated with azathioprine. Hepatitis B virus reactivation is the most serious gastrointestinal disease risk associated with many biological therapies, particularly rituximab...
February 2018: Rheumatic Diseases Clinics of North America
https://www.readbyqxmd.com/read/29149474/interventions-for-old-world-cutaneous-leishmaniasis
#16
REVIEW
Julio Heras-Mosteiro, Begoña Monge-Maillo, Mariona Pinart, Patricia Lopez Pereira, Emely Garcia-Carrasco, Pedro Campuzano Cuadrado, Ana Royuela, Irene Mendez Roman, Rogelio López-Vélez
BACKGROUND: Cutaneous leishmaniasis, caused by a parasitic infection, is considered one of the most serious skin diseases in many low- and middle-income countries. Old World cutaneous leishmaniasis (OWCL) is caused by species found in Africa, Asia, the Middle East, the Mediterranean, and India. The most commonly prescribed treatments are antimonials, but other drugs have been used with varying success. As OWCL tends to heal spontaneously, it is necessary to justify the use of systemic and topical treatments...
November 17, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29149126/pharmacogenomics-principles-and-relevance-to-oncology-nursing%C3%A2
#17
Crystal H Dodson
BACKGROUND: Pharmacogenomics is the fastest growing field in precision medicine. Based on current use, oncology encompasses the largest share of the precision medicine market, necessitating that oncology nurses understand the principles of pharmacogenomics and how it affects clinical practice.
. OBJECTIVES: This article will define precision medicine and pharmacogenomics and will provide examples of pharmacogenomic tests, including those associated with tumor markers, and nursing implications...
December 1, 2017: Clinical Journal of Oncology Nursing
https://www.readbyqxmd.com/read/29148589/determination-of-telbivudine-in-the-plasma-of-chronic-hepatitis-b-patients-in-long-term-treatment-by-high-performance-liquid-chromatographic-tandem-mass-spectrometry
#18
Bicui Chen, Li Chen, Cai Cheng, Mingkang Zhong, Xiaojin Shi, Jiming Zhang, Bin Wang
Usually, creatine kinase elevation is commonly reported in telbivudine-treated patients. However, little is known abosut the relationship between this adverse drug reaction and plasma concentration. In this study, a sensitive, rapid and safe quantitative bioanalytical method has been established by using LC-MS/MS for the determination of telbivudine in a clinical study of chronic hepatitis B (CHB) patients. The assay was linear in a dynamic 10-10,000 ng/mL range (r(2) > 0.999) and total analysis time was 6 min in this method...
November 17, 2017: Biomedical Chromatography: BMC
https://www.readbyqxmd.com/read/29148077/drug-related-deaths-in-hospital-inpatients-a-retrospective-cohort-study
#19
E Montané, A L Arellano, Y Sanz, J Roca, M Farré
OBJECTIVES: To determine the incidence of drug-related deaths (DRD) in a university hospital in 2015, to describe their characteristics, and to discover risk factors of DRD. METHODS: An analytic and retrospective cohort study. Patients with a death diagnose predefined from a list of medical conditions potentially caused by drugs were the selected cases for further review. Causality assessment was evaluated by a local drug safety committee. RESULTS: Out of 1,135 inpatients deaths, 73 DRD were included (6 were hospital-acquired)...
November 17, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29147963/inappropriate-anticholinergic-drugs-prescriptions-in-older-patients-analysing-a-hospital-database
#20
Laurie Ferret, Gregoire Ficheur, Emeline Delaviez, Michel Luyckx, Sophie Quenton, Regis Beuscart, Emmanuel Chazard, Jean-Baptiste Beuscart
Background Although many anticholinergics are inappropriate in older patients, the prescription of these drugs in a hospital setting has not been extensively studied. Objective To describe prescriptions of anticholinergic drugs in terms of frequency, at risk situations and constipation in hospitalized, older adults. Setting Using a database from a French general hospital (period 2009-2013), we extracted information on 14,090 hospital stays by patients aged 75 and over. Methods Anticholinergic drug prescriptions were automatically detected, with a focus on prescriptions in three well-known at-risk situations: falls, dementia, and benign prostatic hyperplasia...
November 17, 2017: International Journal of Clinical Pharmacy
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