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Drug Safety: An International Journal of Medical Toxicology and Drug Experience

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https://www.readbyqxmd.com/read/27900668/propensity-score-weighting-compared-to-matching-in-a-study-of-dabigatran-and-warfarin
#1
John D Seeger, Katsiaryna Bykov, Dorothee B Bartels, Krista Huybrechts, Sebastian Schneeweiss
INTRODUCTION: Comparing medications in observational settings requires differences in patient characteristics to be accounted for. Propensity score (PS) methods can address these differences, but PS weighting approaches may introduce bias. METHODS: Within a cohort study of anticoagulant initiators from October 2010 through to December 2012, PS values for dabigatran relative to warfarin were estimated, and study outcomes (stroke or major bleeding) among the cohort were identified...
November 29, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/27900667/should-domperidone-be-used-as-a-galactagogue-possible-safety-implications-for-mother-and-child
#2
Luc M Hondeghem, Noël H Logghe
Domperidone has been used as a galactagogue; however, solid evidence from an adequate sized randomized clinical trial is missing. Optimal dosage, start of treatment, length of treatment and scope of patients who can benefit also remain unknown. Although milk obtained after domperidone administration has not been shown to have untoward effects on newborns, no sufficiently large randomized clinical trial has been done to establish safety. Domperidone has repeatedly been shown to produce sudden cardiac death, starting at 30 mg/day...
November 29, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/27896662/investigating-the-additive-interaction-of-qt-prolonging-drugs-in-older-people-using-claims-data
#3
Andreas D Meid, Anna von Medem, Dirk Heider, Jürgen-Bernhard Adler, Christian Günster, Hanna M Seidling, Renate Quinzler, Hans-Helmut König, Walter E Haefeli
INTRODUCTION: Drugs that potentially prolong the QT interval carry the risk of life-threatening Torsades de pointes (TdP) ventricular arrhythmia. OBJECTIVE: The objective of this study was to investigate the potential additive risk for ventricular arrhythmia with concomitant prescriptions of QT-prolonging drugs. METHODS: Claims data for persons aged ≥65 years between 2010 and 2012 in Germany were analyzed and all cases hospitalized for ventricular arrhythmia were selected...
November 29, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/27878468/the-risk-of-adverse-pregnancy-outcome-after-first-trimester-exposure-to-h1-antihistamines-a-systematic-review-and-meta-analysis
#4
REVIEW
Fatma Etwel, Lauren H Faught, Michael J Rieder, Gideon Koren
INTRODUCTION: H1 antihistamines are used for the treatment of nausea and vomiting during pregnancy as well as the symptomatic relief of asthma, urticaria, allergy, and the common cold. Although they are overall felt to be safe during pregnancy, recently several studies have challenged this assumption, as millions of women are exposed to them in the first trimester. METHODS: Following the guidelines of PRISMA, a systematic review was performed to retrieve all published articles involving H1-antihistamine exposure during pregnancy...
November 22, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/27873192/on-the-potential-of-preemptive-genotyping-towards-preventing-medication-related-adverse-events-results-from-the-south-korean-national-health-insurance-database
#5
LETTER
Jonathan S Schildcrout, Joshua C Denny, Dan M Roden
No abstract text is available yet for this article.
November 21, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/27864791/the-harms-of-antipsychotic-drugs-evidence-from-key-studies
#6
Thomas J Moore, Curt D Furberg
This safety assessment provides a detailed analysis of key studies and focuses on the six most widely used antipsychotic drugs. Lines of evidence include mechanisms of action, short-term treatment of psychosis, relapse prevention, early intervention in schizophrenia, long-term comparisons between first- and second-generation agents, and flexible treatment algorithms. Despite the diversity of study settings, several common features were seen. All the agents obstruct normal signaling through widely dispersed dopamine D2 receptors...
November 19, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/27848201/the-role-of-hemoglobin-laboratory-test-results-for-the-detection-of-upper-gastrointestinal-bleeding-outcomes-resulting-from-the-use-of-medications-in-observational-studies
#7
Elisabetta Patorno, Joshua J Gagne, Christine Y Lu, Kevin Haynes, Andrew T Sterrett, Jason Roy, Xingmei Wang, Marsha A Raebel
INTRODUCTION: The identification of upper gastrointestinal (UGI) bleeding and perforated ulcers in claims data typically relies on inpatient diagnoses. The use of hemoglobin laboratory results might increase the detection of UGI events that do not lead to hospitalization. OBJECTIVES: Our objective was to evaluate whether hemoglobin results increase UGI outcome identification in electronic databases, using non-steroidal anti-inflammatory drugs (NSAIDs) as a test case...
November 15, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/27848200/vancomycin-induced-thrombocytopenia-a-narrative-review
#8
REVIEW
Mehdi Mohammadi, Zahra Jahangard-Rafsanjani, Amir Sarayani, Molouk Hadjibabaei, Maryam Taghizadeh-Ghehi
Thrombocytopenia has been reported as an adverse reaction of numerous drugs. Vancomycin is often overlooked as a culprit but has been associated with several cases of thrombocytopenia that were not well described in the literature. A literature search was conducted to find reports of thrombocytopenia induced by vancomycin. Biomedical databases including 'PubMed', 'Scopus', and 'Web of Science' were searched using terms 'vancomycin', 'platelet', 'pancytopenia', 'thrombocytopenia', and 'bleeding'. English language articles published before July 2015 were included...
November 15, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/27838824/proton-pump-inhibitors-and-risk-of-rhabdomyolysis
#9
REVIEW
Scott J Duncan, Colin W Howden
Proton pump inhibitors (PPIs) have been associated with a variety of adverse events, although the level of evidence for many of these is weak at best. Recently, one national regulatory authority has mandated a change to the labeling of one PPI based on reports of possible associated rhabdomyolysis. Thus, in this review we summarize the available evidence linking PPI use with rhabdomyolysis. The level of evidence is insufficient to establish a causal relationship and is largely based on sporadic case reports...
November 12, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/27838823/active-surveillance-of-follow-on-biologics-a-prescription-for-uptake
#10
Ameet Sarpatwari, Joshua J Gagne, Nicole L Levidow, Aaron S Kesselheim
As lower-cost versions of original biologic drugs made by different manufacturers, follow-on biologics offer the promise of meaningful savings for the US health care system and improved patient health outcomes through greater medication adherence. Fulfillment of this promise, however, is predicated on the prescribing of such products. Under state drug product selection laws, pharmacists may substitute prescriptions for brand name, small-molecule drugs with their generic equivalents, but will be indefinitely prohibited from substituting prescriptions for original biologics with their follow-on biologic counterparts given a lack of product-specific guidance on demonstrating interchangeability...
November 12, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/27826881/bone-fractures-with-sodium-glucose-co-transporter-2-inhibitors-how-real-is-the-risk
#11
REVIEW
Edoardo Mannucci, Matteo Monami
This article succinctly summarizes the available evidence on the risk of bone fractures with sodium-glucose co-transporter-2 inhibitors. The US Food and Drug Administration has strengthened the warning for canagliflozin related to the increased risk of bone fractures, and added new information about decreased bone mineral density. The agency has also said that it will evaluate the risk of bone fractures with other drugs in the sodium-glucose co-transporter-2 inhibitor class. Increases in parathyroid hormone levels and decreases in 1,25-dihydroxyvitamin D levels have been postulated as possible mechanisms...
November 8, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/27826880/acknowledgement-to-referees
#12
(no author information available yet)
No abstract text is available yet for this article.
November 8, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/27785767/on-designs-for-vaccine-surveillance
#13
LETTER
Robert W Platt
No abstract text is available yet for this article.
October 26, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/27743334/pharmaceutical-benefit-risk-communication-tools-a-review-of-the-literature
#14
Dominic Way, Hortense Blazsin, Ragnar Löfstedt, Frederic Bouder
This paper reviews the main tools for communicating benefit-risk medicines information to patients that are used, or could be used, by pharmaceutical regulators. One highly successful tool from the food safety sector (front-of-package traffic-light labelling) and the mental models approach (which provides a framework for developing new tools) are also reviewed as they show great promise for being usefully adapted to the pharmaceutical context. The evolution of benefit-risk medicines communication is first contextualised within the broader risk communication literature...
October 14, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/27743333/knowledge-of-adverse-drug-reaction-reporting-among-healthcare-professionals-in-bhutan-a-cross-sectional-survey
#15
Choki Dorji, Pramote Tragulpiankit, Arthorn Riewpaiboon, Tashi Tobgay
INTRODUCTION: The Bhutan National Pharmacovigilance Centre (NPC) became an official member of the WHO Programme for International Drug Monitoring in December 2014; however, the number of adverse drug reactions (ADRs) reported is very low (50 reports per 773,722 inhabitants over 10 years). Surveys of healthcare professionals (HCPs) in similar countries have indicated that adequate knowledge of both ADRs and ADR reporting is likely to increase the number of ADR reports submitted. OBJECTIVE: The aim of this study was to investigate the level of knowledge of both ADRs and ADR reporting among HCPs, including traditional medicine practitioners...
October 14, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/27696299/treatment-related-progressive-multifocal-leukoencephalopathy-in-multiple-sclerosis-a-comprehensive-review-of-current-evidence-and-future-needs
#16
Emanuele D'Amico, Aurora Zanghì, Carmela Leone, Hayrettin Tumani, Francesco Patti
Progressive multifocal leukoencephalopathy (PML) is a rare opportunistic infection of the central nervous system caused by the John Cunningham virus (JCV) that has been associated with therapeutic immunosuppression in patients with multiple sclerosis (MS). So far, more than 600 cases of PML have been reported in association with natalizumab administration. There have also been confirmed cases of PML in individuals who received fingolimod and dimethyl fumarate without previous natalizumab treatment. The new licensed disease-modifying therapies for MS carry the risk of immunosuppressant and so of JCV reactivation...
September 30, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/27688026/estimating-herbal-product-authentication-and-adulteration-in-india-using-a-vouchered-dna-based-biological-reference-material-library
#17
Dhivya Shanmughanandhan, Subramanyam Ragupathy, Steven G Newmaster, Saravanan Mohanasundaram, Ramalingam Sathishkumar
INTRODUCTION: India is considered the 'medicinal garden' of the world, with 8000 medicinal plants of which 960 are commercial species that are traded nationally and globally. Although scientific studies estimate herbal product adulteration as 42-66 % in North America, India does not have any published marketplace studies and subsequent estimates of adulteration in an industry facing considerable supply demands. OBJECTIVES: The goal of this project is to provide an initial assessment of herbal product authentication and adulteration in the marketplace in India by (1) developing a biological reference material (BRM) herbal DNA library for Indian herbal species using DNA barcode regions (ITS2 and rbcL) in order to facilitate accurate species resolution when testing the herbal products; and (2) assessing herbal product identification using our BRM library; and (3) comparing the use of our BRM library to identify herbal products with that of GenBank...
September 29, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/27688025/completeness-of-spontaneous-adverse-drug-reaction-reports-sent-by-general-practitioners-to-a-regional-pharmacovigilance-centre-a-descriptive-study
#18
Geneviève Durrieu, Julien Jacquot, Mathilde Mège, Emmanuelle Bondon-Guitton, Vanessa Rousseau, François Montastruc, Jean-Louis Montastruc
INTRODUCTION: Spontaneous reporting of adverse drug reactions (ADRs) remains the cornerstone of postmarketing drug safety surveillance (pharmacovigilance); however, one of its main limitations is incomplete data, thus limiting conclusions about causality assessment. OBJECTIVE: The primary aim of this study was to assess the completeness of ADR reports sent by general practitioners (GPs) to regional pharmacovigilance centres and the secondary objective was to identify factors associated with complete ADR reports...
September 29, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/27677637/the-risk-of-achilles-or-biceps-tendon-rupture-in-new-statin-users-a-propensity-score-matched-sequential-cohort-study
#19
Julia Spoendlin, J Bradley Layton, Mallika Mundkur, Christian Meier, Susan S Jick, Christoph R Meier
INTRODUCTION: Case reports and pharmacovigilance data reported cases of tendon ruptures in statin users, but evidence from observational studies is scarce and inconclusive. We aimed to assess the association between new statin use and tendon rupture. METHODS: We performed a propensity score (PS)-matched sequential cohort study, using data from the Clinical Practice Research Datalink. Patients aged ≥45 years with at least one new statin prescription between 1995 and 2014 were PS-matched within 2-year entry blocks to patients without a statin prescription during the block...
September 27, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/27638661/current-safety-concerns-with-human-papillomavirus-vaccine-a-cluster-analysis-of-reports-in-vigibase-%C3%A2
#20
Rebecca E Chandler, Kristina Juhlin, Jonas Fransson, Ola Caster, I Ralph Edwards, G Niklas Norén
INTRODUCTION: A number of safety signals-complex regional pain syndrome (CRPS), postural orthostatic tachycardia syndrome (POTS), and chronic fatigue syndrome (CFS)-have emerged with human papillomavirus (HPV) vaccines, which share a similar pattern of symptomatology. Previous signal evaluations and epidemiological studies have largely relied on traditional methodologies and signals have been considered individually. OBJECTIVE: The aim of this study was to explore global reporting patterns for HPV vaccine for subgroups of reports with similar adverse event (AE) profiles...
September 16, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
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