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

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https://www.readbyqxmd.com/read/29332144/long-acting-%C3%AE-2-agonists-in-asthma-enantioselective-safety-studies-are-needed
#1
Glenn A Jacobson, Sharanne Raidal, Morten Hostrup, Luigino Calzetta, Richard Wood-Baker, Mark O Farber, Clive P Page, E Haydn Walters
Long-acting β2-agonists (LABAs) such as formoterol and salmeterol are used for prolonged bronchodilatation in asthma, usually in combination with inhaled corticosteroids (ICSs). Unexplained paradoxical asthma exacerbations and deaths have been associated with LABAs, particularly when used without ICS. LABAs clearly demonstrate effective bronchodilatation and steroid-sparing activity, but long-term treatment can lead to tolerance of their bronchodilator effects. There are also concerns with regard to the effects of LABAs on bronchial hyperresponsiveness (BHR), where long-term use is associated with increased BHR and loss of bronchoprotection...
January 13, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29330715/case-series-analysis-of-new-zealand-reports-of-rapid-intense-potentiation-of-warfarin-by-roxithromycin
#2
Ruth L Savage, Michael V Tatley
INTRODUCTION: We undertook an analysis of all the reports to the New Zealand Centre for Adverse Reactions Monitoring of a roxithromycin/warfarin interaction after two recent reports described intense rapid warfarin potentiation. The interaction was first published in 1995. Cytochrome P450 3A4 inhibition has been the proposed mechanism but has limited biologic plausibility. There are suggestions that the clinical significance of the interaction may be increased by severe illness, polypharmacy, renal dysfunction, older age and increased warfarin sensitivity...
January 12, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29330714/evidence-based-recommendations-to-improve-the-safe-use-of-drugs-in-patients-with-liver-cirrhosis
#3
Rianne A Weersink, Margriet Bouma, David M Burger, Joost P H Drenth, S Froukje Harkes-Idzinga, Nicole G M Hunfeld, Herold J Metselaar, Margje H Monster-Simons, Katja Taxis, Sander D Borgsteede
INTRODUCTION: The presence of liver cirrhosis can have a major impact on pharmacodynamics and pharmacokinetics, but guidance for prescribing is lacking. OBJECTIVE: The aim of this study is to provide an overview of evidence-based recommendations developed for the safe use of drugs in liver cirrhosis. METHODS: Recommendations were based on a systematic literature search combined with expert opinion from a panel of 10 experts. The safety of each drug was classified as safe, no additional risks known, additional risks known, unsafe, unknown or the safety class was dependent on the severity of liver cirrhosis (Child-Pugh classification)...
January 12, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29327136/signal-detection-for-recently-approved-products-adapting-and-evaluating-self-controlled-case-series-method-using-a-us-claims-and-uk-electronic-medical-records-database
#4
Xiaofeng Zhou, Ian J Douglas, Rongjun Shen, Andrew Bate
INTRODUCTION: The Self-Controlled Case Series (SCCS) method has been widely used for hypothesis testing, but there is limited evidence of its performance for safety signal detection. OBJECTIVE: The objective of this study was to evaluate SCCS for signal detection on recently approved products. METHODS: A retrospective study covered the period after three recently marketed drugs were launched through to 31 December 2010 using The Health Improvement Network, a UK primary care database, and Optum, a US claims database...
January 11, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29318515/a-review-of-methods-for-monitoring-adverse-events-in-pediatric-psychopharmacology-clinical-trials
#5
REVIEW
Margaret Coates, Marina Spanos, Pooja Parmar, Tara Chandrasekhar, Linmarie Sikich
Pediatric psychotropic prescription rates are rising, emphasizing the need for careful monitoring of drug safety in this population. Currently, no standardized assessments are used in clinical trials for adverse event (AE) elicitation focused on long-term drug treatment in pediatric patients. Despite a lack of standardized AE elicitation methods in psychiatric clinical trials, it is clear that psychiatric medications have developmentally dependent AEs that differ from those observed in adults. In this review, we discuss the use of general inquiry elicitation, drug-specific checklists, and systematic elicitation scales for AE reporting in pediatric psychopharmacology trials...
January 9, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29318514/the-impact-of-biologics-and-tofacitinib-on-cardiovascular-risk-factors-and-outcomes-in-patients-with-rheumatic-disease-a-systematic-literature-review
#6
REVIEW
Michael Nurmohamed, Ernest Choy, Sadiq Lula, Blerina Kola, Ryan DeMasi, Paola Accossato
INTRODUCTION: Rheumatic diseases are autoimmune, inflammatory diseases often associated with cardiovascular (CV) disease, a major cause of mortality in these patients. In recent years, treatment with biologic and targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs), either as monotherapy or in combination with other drugs, have become the standard of treatment. In this systematic literature review, we evaluated the effect of treatment with biologic or tofacitinib on the CV risk and outcomes in these patients...
January 9, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29313311/the-safety-of-generic-prescription-drugs-in-the-united-states
#7
Sonal Singh
No abstract text is available yet for this article.
January 8, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29285728/setting-standards-for-pregnancy-registries
#8
LETTER
Lewis B Holmes
No abstract text is available yet for this article.
December 28, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29280070/safety-of-human-papillomavirus-vaccines-an-updated-review
#9
REVIEW
Anastasia Phillips, Cyra Patel, Alexis Pillsbury, Julia Brotherton, Kristine Macartney
Human papillomavirus (HPV) vaccines are now included in immunisation programmes in 71 countries. Unfortunately, uptake has been impacted in some countries by reduced confidence in the safety of the HPV vaccine. In 2013, we published an extensive review demonstrating a reassuring safety profile for bivalent (2vHPV) and quadrivalent (4vHPV) vaccines. A nonavalent (9vHPV) vaccine is now available and HPV immunisation programmes have been extended to males in 11 countries. The aim of this updated narrative review was to examine the evidence on HPV vaccine safety, focusing on the 9vHPV vaccine, special populations and adverse events of special interest (AESI)...
December 26, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29270770/adverse-drug-reaction-reports-received-through-the-mobile-app-vigibip%C3%A2-a-comparison-with-classical-methods-of-reporting
#10
François Montastruc, Haleh Bagheri, Isabelle Lacroix, Christine Damase-Michel, Leila Chebane, Vanessa Rousseau, Emilie Jouanjus, Maryse Lapeyre-Mestre, Geneviève Durrieu, Jean-Louis Montastruc
INTRODUCTION: The use of mobile apps is increasing in medicine. In pharmacovigilance, mobile apps may help to increase adverse drug reaction reporting and improve the communication of safety issues. The Toulouse University Pharmacovigilance Center has developed VigiBIP®, a free smartphone app available on Android and Apple stores, for reporting adverse drug reactions and requesting drug safety information. OBJECTIVE: The present study was performed to compare the main characteristics of spontaneous adverse drug reaction reports received through VigiBIP® with classical methods of reporting (phone, e-mail, fax, letter, website) during 25 months (2015-17)...
December 21, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29230691/beta-blocker-use-in-pregnancy-and-risk-of-specific-congenital-anomalies-a-european-case-malformed-control-study
#11
Jorieke E H Bergman, L Renée Lutke, Rijk O B Gans, Marie-Claude Addor, Ingeborg Barisic, Clara Cavero-Carbonell, Ester Garne, Miriam Gatt, Kari Klungsoyr, Nathalie Lelong, Catherine Lynch, Olatz Mokoroa, Vera Nelen, Amanda J Neville, Anna Pierini, Hanitra Randrianaivo, Anke Rissmann, David Tucker, Awi Wiesel, Helen Dolk, Maria Loane, Marian K Bakker
INTRODUCTION: The prevalence of chronic hypertension is increasing in pregnant women. Beta-blockers are among the most prevalent anti-hypertensive agents used in early pregnancy. OBJECTIVE: The objective of this study was to investigate whether first-trimester use of beta-blockers increases the risk of specific congenital anomalies in offspring. METHODS: A population-based case-malformed control study was conducted in 117,122 registrations of congenital anomalies from 17 European Concerted Action on Congenital Anomalies and Twins (EUROCAT) registries participating in EUROmediCAT with data for all or part of the period between 1995 and 2013...
December 11, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29218682/the-rimes-statement-a-checklist-to-assess-the-quality-of-studies-evaluating-risk-minimization-programs-for-medicinal-products
#12
Meredith Y Smith, Andrea Russell, Priya Bahri, Peter G M Mol, Sarah Frise, Emily Freeman, Elaine H Morrato
INTRODUCTION: Pharmaceutical risk minimization programs involve interventions designed to support safe and appropriate use of medicines. Currently, information regarding the evaluation of these programs is not publicly reported in a standardized and transparent manner. To address this gap, we developed and piloted a quality reporting checklist entitled the Reporting recommendations Intended for pharmaceutical risk Minimization Evaluation Studies (RIMES). METHODS: Checklist development was guided by three sources: (1) a theoretical framework derived from program theory and process evaluation; (2) public health intervention design and evaluation principles; and (3) a review of existing quality reporting checklists...
December 7, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29218681/management-strategies-to-facilitate-optimal-outcomes-for-patients-treated-with-delayed-release-dimethyl-fumarate
#13
Lori Mayer, Mary Kay Fink, Carrie Sammarco, Lisa Laing
Delayed-release dimethyl fumarate is an oral disease-modifying therapy that has demonstrated significant efficacy in adults with relapsing-remitting multiple sclerosis. Incidences of flushing and gastrointestinal adverse events are common in the first month after delayed-release dimethyl fumarate initiation. Our objective was to propose mitigation strategies for adverse events related to initiation of delayed-release dimethyl fumarate in the treatment of patients with multiple sclerosis. Studies of individually developed mitigation strategies and chart reviews were evaluated...
December 7, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29218680/cardiovascular-profile-of-valbenazine-analysis-of-pooled-data-from-three-randomized-double-blind-placebo-controlled-trials
#14
Dao Thai-Cuarto, Christopher F O'Brien, Roland Jimenez, Grace S Liang, Joshua Burke
INTRODUCTION: Valbenazine is a novel vesicular monoamine transporter 2 inhibitor approved for the treatment of tardive dyskinesia in adults. OBJECTIVE: Using data from double-blind, placebo-controlled trials, analyses were conducted to evaluate the cardiovascular effects of once-daily valbenazine in patients with a psychiatric disorder who developed tardive dyskinesia after exposure to a dopamine-blocking medication. METHODS: Data were pooled from three 6-week, double-blind, placebo-controlled trials: KINECT (NCT01688037), KINECT 2 (NCT01733121), and KINECT 3 (NCT02274558)...
December 7, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29196989/mixed-approach-retrospective-analyses-of-suicide-and-suicidal-ideation-for-brand-compared-with-generic-central-nervous-system-drugs
#15
Ning Cheng, Md Motiur Rahman, Yasser Alatawi, Jingjing Qian, Peggy L Peissig, Richard L Berg, C David Page, Richard A Hansen
INTRODUCTION: Several different types of drugs acting on the central nervous system (CNS) have previously been associated with an increased risk of suicide and suicidal ideation (broadly referred to as suicide). However, a differential association between brand and generic CNS drugs and suicide has not been reported. OBJECTIVES: This study compares suicide adverse event rates for brand versus generic CNS drugs using multiple sources of data. METHODS: Selected examples of CNS drugs (sertraline, gabapentin, zolpidem, and methylphenidate) were evaluated via the US FDA Adverse Event Reporting System (FAERS) for a hypothesis-generating study, and then via administrative claims and electronic health record (EHR) data for a more rigorous retrospective cohort study...
December 2, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29196988/analysis-of-spontaneous-postmarket-case-reports-submitted-to-the-fda-regarding-thromboembolic-adverse-events-and-jak-inhibitors
#16
Abril Verden, Mo Dimbil, Robert Kyle, Brian Overstreet, Keith B Hoffman
INTRODUCTION: The Janus kinase (JAK) inhibitor baricitinib is approved in Europe and Japan for the treatment of rheumatoid arthritis. In April 2017, the US FDA expressed concern about thromboembolic events (deep venous thrombosis [DVT] and pulmonary embolism [PE]) observed in placebo-controlled clinical trials of baricitinib. The European and Japanese labels for baricitinib were recently updated to include a precaution related to potential thromboembolic events in patients at risk. Given that the FDA-approved drugs tofacitinib and ruxolitinib are in the same class, we conducted a safety review of the FDA's Adverse Event Reporting System (FAERS) to assess postmarketing reporting rates for related thromboembolic risks...
December 2, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29185237/using-human-experiments-of-nature-to-predict-drug-safety-issues-an-example-with-pcsk9-inhibitors
#17
Rebecca N Jerome, Jill M Pulley, Dan M Roden, Jana K Shirey-Rice, Lisa A Bastarache, Gordon R Bernard, Leeland B Ekstrom, William J Lancaster, Joshua C Denny
INTRODUCTION: When a new drug enters the market, its full array of side effects remains to be defined. Current surveillance approaches targeting these effects remain largely reactive. There is a need for development of methods to predict specific safety events that should be sought for a given new drug during development and postmarketing activities. OBJECTIVE: We present here a safety signal identification approach applied to a new set of drug entities, inhibitors of the serine protease proprotein convertase subtilisin/kexin type 9 (PCSK9)...
November 28, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29185236/an-automated-system-combining-safety-signal-detection-and-prioritization-from-healthcare-databases-a-pilot-study
#18
Mickael Arnaud, Bernard Bégaud, Frantz Thiessard, Quentin Jarrion, Julien Bezin, Antoine Pariente, Francesco Salvo
INTRODUCTION: Signal detection from healthcare databases is possible, but is not yet used for routine surveillance of drug safety. One challenge is to develop methods for selecting signals that should be assessed with priority. AIM: The aim of this study was to develop an automated system combining safety signal detection and prioritization from healthcare databases and applicable to drugs used in chronic diseases. METHODS: Patients present in the French EGB healthcare database for at least 1 year between 2005 and 2015 were considered...
November 28, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29143285/comment-on-adverse-drug-reaction-related-hospitalizations-in-elderly-australians-a-prospective-cross-sectional-study-in-two-tasmanian-hospitals
#19
LETTER
Mona Kargar, Alireza Ahmadvand, Kheirollah Gholami
No abstract text is available yet for this article.
November 15, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29134610/authors-reply-to-mona-kargar-and-colleagues-comment-on-adverse-drug-reaction-related-hospitalizations-in-elderly-australians-a-prospective-cross-sectional-study-in-two-tasmanian-hospitals
#20
LETTER
Nibu Parameswaran Nair, Leanne Chalmers, Bonnie J Bereznicki, Colin Curtain, Gregory M Peterson, Michael Connolly, Luke R Bereznicki
No abstract text is available yet for this article.
November 13, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
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