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Adverse drug reaction

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https://www.readbyqxmd.com/read/28654904/digoxin-induced-anemia-among-patients-with-atrial-fibrillation-and-heart-failure-clinical-data-analysis-and-drug-gene-interaction-network
#1
Yubi Lin, Siqi He, Ruiling Feng, Zhe Xu, Wanqun Chen, Zifeng Huang, Yang Liu, Qianhuan Zhang, Bin Zhang, Kejian Wang, Shulin Wu
Digoxin is widely used to treat various heart conditions. In order to clarify the association between digoxin and anemia adverse reaction, we inspected case reports submitted to the FDA Adverse Event Reporting System (FAERS) between January 2004 and December 2015. These reports involved 75618 atrial fibrillation patients and 15699 heart failure patients. Compared to other therapies, digoxin treatment was significantly more likely to be concurrent with anemia adverse reaction among both atrial fibrillation patients (pooled OR = 1...
June 16, 2017: Oncotarget
https://www.readbyqxmd.com/read/28654193/serotonin-transporter-gene-polymorphisms-and-ssri-tolerability-review-of-pharmacogenetic-evidence
#2
Jing Zhu, Michele Klein-Fedyshin, James M Stevenson
BACKGROUND: Selective serotonin reuptake inhibitors (SSRIs) are first-line pharmacotherapy for mood and anxiety disorders. The common mechanism of drugs in this class is antagonism of the serotonin transporter. Within the serotonin transporter gene SLC6A4, two polymorphic sites termed 5-HTTLPR and STin2 are proposed to have functional consequences and thus have been attractive candidates for pharmacogenetic studies of SSRI efficacy and tolerability studies. OBJECTIVE: This review summarizes approximately 15 years of study of these polymorphisms as they relate to SSRI tolerability phenotypes...
June 27, 2017: Pharmacotherapy
https://www.readbyqxmd.com/read/28653802/safety-profile-of-h1-antihistamines-in-pediatrics-an-analysis-based-on-data-from-vigibase
#3
Domenico Motola, Monia Donati, Chiara Biagi, Elisabetta Calamelli, Francesca Cipriani, Mauro Melis, Luca Monaco, Alberto Vaccheri, Giampaolo Ricci
PURPOSE: H1-antihistamines are commonly used in infants and children for the relief of histamine-mediated symptoms in a variety of conditions. Little is known about their safety profile in these patients. We performed a comparative analysis of the safety profiles of H1-antihistamines using data from the WHO database (VigiBase). METHODS: We selected adverse drug reaction (ADR) reports on H1-antihistamines in children (0-16 years) up to June 2014 from VigiBase. ADRs were codified according to MedDRA terminology...
June 27, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28653790/vigirank-for-statistical-signal-detection-in-pharmacovigilance-first-results-from-prospective-real-world-use
#4
Ola Caster, Lovisa Sandberg, Tomas Bergvall, Sarah Watson, G Niklas Norén
PURPOSE: vigiRank is a data-driven predictive model for emerging safety signals. In addition to disproportionate reporting patterns, it also accounts for the completeness, recency, and geographic spread of individual case reporting, as well as the availability of case narratives. Previous retrospective analysis suggested that vigiRank performed better than disproportionality analysis alone. The purpose of the present analysis was to evaluate its prospective performance. METHODS: The evaluation of vigiRank was based on real-world signal detection in VigiBase...
June 27, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28653374/a-familial-mediterranean-fever-flare-induced-by-a-drug-reaction-with-eosinophilia-and-systemic-symptoms
#5
A Deschamps, A Samain, P Carvalho, P Courville, H Levesque, P Musette, P Joly
Familial Mediterranean Fever (FMF) is an autosomal recessive inherited auto-inflammatory disease revealed by flare episodes characterized by systemic symptoms (pleural, joint serositis, abdominal pain…) that are triggered by infections, cold or menstruations. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) is a severe cutaneous adverse reaction characterized by visceral involvement and viral reactivation including HHV6, HHV7, EBV, CMV… and may be associated with certain HLA alleles. This article is protected by copyright...
June 27, 2017: Journal of the European Academy of Dermatology and Venereology: JEADV
https://www.readbyqxmd.com/read/28653291/patients-perspectives-on-adverse-drug-reaction-reporting-in-a-developing-country-a-case-study-from-ghana
#6
George Tsey Sabblah, Delese Mimi Darko, Hudu Mogtari, Linda Härmark, Eugène van Puijenbroek
INTRODUCTION: Recent efforts to introduce direct patient reporting into pharmacovigilance systems have proved that patient reports contribute significantly to medicine safety, but there is a paucity of information relating to patients' perspectives regarding adverse drug reaction reporting in developing countries. OBJECTIVE: The objective of this study was to explore patients' knowledge, attitudes, behaviours and opinions on spontaneous adverse drug reaction reporting in Ghana...
June 26, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28652744/assessment-of-safety-and-efficacy-of-lamotrigine-over-the-course-of-1-year-observation-in-japanese-patients-with-bipolar-disorder-post-marketing-surveillance-study-report
#7
Takeshi Terao, Atsuko Ishida, Toshifumi Kimura, Mitsuhiro Yoshida, Terufumi Hara
BACKGROUND: A post-marketing surveillance (PMS) study was conducted with a 1-year observation period to assess the safety and efficacy of lamotrigine in routine clinical practice in patients with bipolar disorder (BD). PATIENTS AND METHODS: Central enrollment method was used to recruit patients diagnosed with BD who were being treated for the first time with lamotrigine to prevent the recurrence/relapse of BD mood episodes. Adverse drug reactions (ADRs) and recurrence/relapse were assessed...
2017: Neuropsychiatric Disease and Treatment
https://www.readbyqxmd.com/read/28651624/multifaceted-interventions-for-improving-spontaneous-reporting-of-adverse-drug-reactions-in-a-general-hospital-in-china
#8
Huan Fang, Xiaowen Lin, Jun Zhang, Zhen Hong, Kenji Sugiyama, Takao Nozaki, Tetsuro Sameshima, Susumu Kobayashi, Hiroki Namba, Tetsuya Asakawa
BACKGROUND: The present study investigates changes in spontaneous reporting (SR) compliance and ADR patterns following adoption of a new hospital SR system, and multiple interventions designed for its improvement use under modified drug administration guidelines. METHODS: In total, 1389 ADR cases were reviewed. Cases were divided into two groups, cases from period 1 (n = 557, from January 2006 to June 2011) under the old SR system and cases in period 2 (n = 832, from July 2011 to December 2016) under the new SR system with multiple interventions to improve physician SR compliance...
June 26, 2017: BMC Pharmacology & Toxicology
https://www.readbyqxmd.com/read/28649878/safety-and-effectiveness-of-tacrolimus-add-on-therapy-for-rheumatoid-arthritis-patients-without-an-adequate-response-to-biological-disease-modifying-anti-rheumatic-drugs-dmards-post-marketing-surveillance-in-japan
#9
Tsutomu Takeuchi, Kota Ishida, Katsuhisa Shiraki, Takashi Yoshiyasu
OBJECTIVES: Post-marketing surveillance (PMS) was conducted to assess the safety and effectiveness of tacrolimus (TAC) add-on therapy for patients with rheumatoid arthritis (RA) and an inadequate response to biological disease-modifying anti-rheumatic drugs (DMARDs). METHODS: Patients with RA from 180 medical sites across Japan were registered centrally with an electronic investigation system. The observational period was 24 weeks from the first day of TAC administration concomitantly with biological DMARDs...
June 26, 2017: Modern Rheumatology
https://www.readbyqxmd.com/read/28649610/evaluation-of-the-safety-and-immunomodulatory-effects-of-sargramostim-in-a-randomized-double-blind-phase-1-clinical-parkinson-s-disease-trial
#10
Howard E Gendelman, Yuning Zhang, Pamela Santamaria, Katherine E Olson, Charles R Schutt, Danish Bhatti, Bhagya Laxmi Dyavar Shetty, Yaman Lu, Katherine A Estes, David G Standaert, Elizabeth Heinrichs-Graham, LuAnn Larson, Jane L Meza, Matthew Follett, Erica Forsberg, Gary Siuzdak, Tony W Wilson, Carolyn Peterson, R Lee Mosley
A potential therapeutic role for immune transformation in Parkinson's disease evolves from more than a decade of animal investigations demonstrating regulatory T cell (Treg) nigrostriatal neuroprotection. To bridge these results to human disease, we conducted a randomized, placebo-controlled double-blind phase 1 trial with a well-studied immune modulator, sargramostim (granulocyte-macrophage colony-stimulating factor). We enrolled 17 age-matched non-Parkinsonian subjects as non-treated controls and 20 Parkinson's disease patients...
2017: NPJ Parkinson's Disease
https://www.readbyqxmd.com/read/28648954/fosphenytoin-induced-purple-glove-syndrome-a-case-report
#11
Joseph W Newman, Joseph R Blunck, Ronald K Fields, John E Croom
BACKGROUND: Purple glove syndrome (PGS) is a poorly understood severe adverse drug reaction that is typically associated with intravenous phenytoin administration. Although fosphenytoin is thought to circumvent this risk of PGS, we reveal a rare case of PGS in a patient treated with fosphenytoin therapy. CASE SUMMARY: A 71-year-old male with history of epilepsy was admitted for seizures and traumatic brain injury and intravenous fosphenytoin and levetiracetam were initiated...
June 19, 2017: Clinical Neurology and Neurosurgery
https://www.readbyqxmd.com/read/28648803/sorafenib-in-combination-with-transarterial-chemoembolisation-in-patients-with-unresectable-hepatocellular-carcinoma-tace-2-a-randomised-placebo-controlled-double-blind-phase-3-trial
#12
Tim Meyer, Richard Fox, Yuk Ting Ma, Paul J Ross, Martin W James, Richard Sturgess, Clive Stubbs, Deborah D Stocken, Lucy Wall, Anthony Watkinson, Nigel Hacking, T R Jeffry Evans, Peter Collins, Richard A Hubner, David Cunningham, John Neil Primrose, Philip J Johnson, Daniel H Palmer
BACKGROUND: Transarterial chemoembolisation (TACE) is the standard of care for patients with intermediate stage hepatocellular carcinoma, while the multikinase inhibitor sorafenib improves survival in patients with advanced disease. We aimed to determine whether TACE with sorafenib improves progression-free survival versus TACE with placebo. METHODS: We did a multicentre, randomised, placebo-controlled, phase 3 trial (TACE 2) in 20 hospitals in the UK for patients with unresectable, liver-confined hepatocellular carcinoma...
June 22, 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28648734/drug-induced-hemolytic-anemia-pharmacological-aspects
#13
D Renard, A Rosselet
Drug-induced hemolytic anemia is a very rare but potentially lethal adverse drug reaction, which can take the form of oxidative damage to vulnerable erythrocytes (as in glucose-6-phosphate dehydrogenase deficiency), drug-induced thrombotic microangiopathy, or immune-mediated hemolytic anemia. For each form, distinctive drugs are documented as potential triggers. When a formal diagnosis of hemolytic anemia is made following drug administration, a structured approach is recommended to assess the plausibility of an adverse drug reaction based on chronological sequence, epidemiological data, objective evidence (when available), and ruling out of non-drug causes...
June 22, 2017: Transfusion Clinique et Biologique: Journal de la Société Française de Transfusion Sanguine
https://www.readbyqxmd.com/read/28648315/psychometric-properties-of-the-patient-reported-outcomes-measure-of-pharmaceutical-therapy-for-quality-of-life-prompt-qol
#14
Phantipa Sakthong, Chanadda Chinthammit, Pattarin Sukarnjanaset, Nontapat Sonsa-Ardjit, Wipaporn Munpan
OBJECTIVES: To assess the psychometric properties of a novel instrument for medication management, the Patient-Reported Outcomes Measure of Pharmaceutical Therapy for Quality of Life (PROMPT-QOL), using both conventional psychometrics and Rasch analysis in a large sample. METHODS: This study was conducted with 1156 adult outpatients continuously taking any medicines at least 3 months from three university hospitals in Bangkok, Thailand, between July 2014 and March 2015...
May 2017: Value in Health Regional Issues
https://www.readbyqxmd.com/read/28647541/response-tailored-protocol-versus-the-fixed-12weeks-of-dual-sofosbuvir-daclatasvir-treatment-in-egyptian-patients-with-chronic-hepatitis-c-genotype-4-infection-a-randomized-open-label-non-inferiority-trial
#15
Mostafa Yakoot, Alaa M Abdo, Siham Abdel-Rehim, Sherine Helmy
BACKGROUND: The most recent European Association for the Study of the Liver (EASL) 2016 Guidelines on treatment of hepatitis C (HCV), allowed for shortening the course of treatment for some subsets of patients with sofosbuvir/ledipasvir and with grazoprevir/elbasvir based on cutoff baseline HCV RNA values. We hypothesized that it would be prudent to also consider an objectively assuring very rapid, on-treatment, virologic response to therapy at week 2 (vRVR) before taking the decision of shortening the treatment duration...
May 17, 2017: EBioMedicine
https://www.readbyqxmd.com/read/28646904/ct-findings-in-patients-with-cabazitaxel-induced-pelvic-pain-and-haematuria-a-case-series
#16
Geethal N Malalagama, Steve Chryssidis, Francis X Parnis
BACKGROUND: Haematuria and pelvic pain are recognized and documented adverse reactions related to Cabazitaxel use. To date there has not been any documentation of imaging findings in patients with this presentation. CASES: We report a case series of five patients who experienced these symptoms while on Cabazitaxel and were all found to have very similar urothelial changes on CT. The patients were noted to have ureteric and renal pelvic dilatation along with urothelial enhancement (in those who had post contrast imaging)...
June 24, 2017: Cancer Imaging: the Official Publication of the International Cancer Imaging Society
https://www.readbyqxmd.com/read/28646789/data-mining-for-detecting-signals-of-adverse-drug-reactions-of-fluoxetine-using-the-korea-adverse-event-reporting-system-kaers-database
#17
Seonji Kim, Kyounghoon Park, Mi-Sook Kim, Bo Ram Yang, Hyun Jin Choi, Byung-Joo Park
Selective serotonin reuptake inhibitors (SSRIs) have become one of the most broadly used medications in psychiatry. Fluoxetine is the first representative antidepressant SSRI drug approved by the Food and Drug Administration (FDA) in 1987. Safety information on fluoxetine use alone was less reported than its combined use with other drugs. There were no published papers on adverse drug reactions (ADRs) of fluoxetine analyzing spontaneous adverse events reports. We detected signals of the adverse drug reactions of fluoxetine by data mining using the Korea Adverse Events Reporting System (KAERS) database...
June 13, 2017: Psychiatry Research
https://www.readbyqxmd.com/read/28646522/pericarditis-during-infliximab-therapy-in-paediatric-ulcerative-colitis
#18
V Dipasquale, S M C Gramaglia, M A Catena, C Romano
WHAT IS KNOWN AND STUDY OBJECTIVE: Infliximab is a widely used drug for treating inflammatory bowel disease (IBD). This drug is known to rarely cause pericarditis in adult populations. CASE SUMMARY: This report details the case of a 14-year-old boy with ulcerative colitis who developed pericarditis after a second infliximab infusion. After discontinuation of therapy, the patient's symptoms were resolved. WHAT IS NEW AND CONCLUSION: To our knowledge, this is the first reported paediatric case of pericarditis as a possible complication of infliximab therapy in IBD...
June 23, 2017: Journal of Clinical Pharmacy and Therapeutics
https://www.readbyqxmd.com/read/28645996/treatment-of-suspected-pulmonary-embolism-in-a-morbidly-obese-patient
#19
Viviene Heitlage, Mary Beth Borgstadt, Lisa Carlson
PURPOSE: A case highlighting challenges with enoxaparin dosage and monitoring in obese patients is presented. SUMMARY: A morbidly obese 22-year-old Caucasian female (height, 168 cm; weight, 322 kg; body mass index [BMI], 114 kg/m(2)) who presented to the emergency department with acute-onset dyspnea and hypoxia was empirically initiated on enoxaparin for suspected pulmonary embolism at the institution's standard maximum dosage (160 mg subcutaneously every 12 hours)...
July 1, 2017: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/28645201/benznidazole-treatment-safety-the-m%C3%A3-decins-sans-fronti%C3%A3-res-experience-in-a-large-cohort-of-bolivian-patients-with-chagas-disease
#20
Gilberto Marcelo Sperandio da Silva, Mauro Felippe Felix Mediano, Alejandro Marcel Hasslocher-Moreno, Marcelo Teixeira de Holanda, Andrea Silvestre de Sousa, Luiz Henrique Conde Sangenis, Pedro Emmanuel Alvarenga Americano do Brasil, Roger Arteaga Mejía, Carina Perotti Fux, Juan-Carlos Cubides, Roberto Magalhães Saraiva, Lucia Maria Brum-Soares
Background: Up to half of patients with Chagas' disease under benznidazole treatment present adverse drug reactions (ADRs) and up to one-third do not complete standard treatment. Objectives: To verify the incidence and possible factors associated with the suspension of benznidazole treatment in a large cohort of patients. Methods: We included 2075 patients treated with benznidazole during the projects managed by the medical humanitarian organization Doctors Without Borders (Médecins Sans Frontières) in Bolivia from 2009 to 2013...
June 22, 2017: Journal of Antimicrobial Chemotherapy
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