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

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https://www.readbyqxmd.com/read/30232743/authors-reply-to-courtney-suggs-and-colleagues-comment-on-mixed-approach-retrospective-analyses-of-suicide-and-suicidal-ideation-for-brand-compared-with-generic-central-nervous-system-drugs
#1
LETTER
Richard A Hansen, Ning Cheng, Md Motiur Rahman, Yasser Alatawi, Jingjing Qian, Peggy L Peissig, Richard L Berg, C David Page
No abstract text is available yet for this article.
September 19, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30232742/first-conference-on-big-data-for-pharmacovigilance
#2
Jae Min, Vicki Osborne, Elizabeth Lynn, Saad A W Shakir
No abstract text is available yet for this article.
September 19, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30232741/nonsteroidal-anti-inflammatory-drugs-and-risk-of-first-hospitalization-for-heart-failure-in-patients-with-no-history-of-heart-failure-a-population-based-case-crossover-study
#3
Sung-Po Huang, Yao-Chun Wen, Shih-Tsung Huang, Chih-Wan Lin, Tzung-Dau Wang, Fei-Yuan Hsiao
INTRODUCTION: Traditional nonselective, nonsteroidal anti-inflammatory drugs (NSAIDs) are known to cause salt and fluid retention and should thus be used cautiously in patients with documented heart failure. Recent studies have found that some NSAIDs, including cyclooxygenase (COX)-2 inhibitors, are associated with an increased risk of incident heart failure regardless of the related medical history of the patient. OBJECTIVE: This study aimed to investigate the potential link between NSAIDs (both COX-2 inhibitors and traditional nonselective NSAIDs) and heart failure in patients without a history of heart failure...
September 19, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30232740/assessment-of-self-administration-of-romiplostim-in-patients-with-immune-thrombocytopenic-purpura-after-receipt-of-home-administration-training-materials-a-cross-sectional-study
#4
Martin Schipperus, Georgia Kaiafa, Louise Taylor, Sally Wetten, Georg Kreuzbauer, Andy Boshier, Anouchka Seesaghur
INTRODUCTION: Romiplostim is a subcutaneously administered thrombopoietin-receptor agonist approved in the European Union for self-administration (or administration by a caregiver) in selected adult patients with chronic primary immune thrombocytopenia refractory to other treatments. To mitigate the risk of medication errors due to self-administration, the manufacturer has implemented additional risk minimisation measures (RMM) in the form of a Home Administration Training (HAT) pack to support the training of both healthcare professionals (HCPs) (guide and checklist for patient selection and training) and patients (a preparation mat, quick guide booklet, step-by-step guide, self-administration diary and DVD/video)...
September 19, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30232739/comment-on-mixed-approach-retrospective-analyses-of-suicide-and-suicidal-ideation-for-brand-compared-with-generic-central-nervous-system-drugs
#5
LETTER
Courtney M Suggs, Robert L Levin, Andrew D Mosholder, Richard S Swain, Liang Zhao
No abstract text is available yet for this article.
September 19, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30167992/methods-to-compare-adverse-events-in-twitter-to-faers-drug-information-databases-and-systematic-reviews-proof-of-concept-with-adalimumab
#6
Karen Smith, Su Golder, Abeed Sarker, Yoon Loke, Karen O'Connor, Graciela Gonzalez-Hernandez
INTRODUCTION: Adverse drug reactions (ADRs) are associated with significant health-related and financial burden, and multiple sources are currently utilized to actively discover them. Social media has been proposed as a potential resource for monitoring ADRs, but drug-specific analytical studies comparing social media with other sources are scarce. OBJECTIVES: Our objective was to develop methods to compare ADRs mentioned in social media with those in traditional sources: the US FDA Adverse Event Reporting System (FAERS), drug information databases (DIDs), and systematic reviews...
August 30, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30155802/risks-of-opioids-in-st-elevation-myocardial-infarction-a-review
#7
REVIEW
Anne Henrieke Tavenier, Renicus Suffridus Hermanides, Jan Paul Ottervanger, Peter Gerrit Johannes Ter Horst, Elvin Kedhi, Adriaan W J van 't Hof
Although opioids are recommended and frequently used in the acute phase of ST-elevation myocardial infarction (STEMI), their use is accompanied by serious side effects. In particular, gastrointestinal adverse effects may disturb absorption of essential oral medication like platelet inhibitors. This may cause suboptimal platelet inhibition and increased risk of acute stent thrombosis. Some clinical studies have already demonstrated these negative results. Alternative strategies to optimize platelet inhibition and pain relief in STEMI are being investigated...
August 28, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30146658/proton-pump-inhibitor-use-and-risk-of-developing-alzheimer-s-disease-or-vascular-dementia-a-case-control-analysis
#8
Patrick Imfeld, Michael Bodmer, Susan S Jick, Christoph R Meier
INTRODUCTION: Long-term use of proton pump inhibitors (PPIs) has been associated with an increased risk of Alzheimer's disease (AD) in observational studies. The role of exposure duration, and whether this applies to other dementia subtypes, has not been explored in these studies. OBJECTIVE: The aim was to study the association between long-term use of PPIs (or of histamine-2 receptor antagonists [H2RAs], as a negative control) and the risk of developing AD or vascular dementia (VaD)...
August 27, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30136244/ibuprofen-and-paracetamol-acceptably-safe-for-all
#9
Filippo Pigazzani, Isla Mackenzie, Thomas M MacDonald
No abstract text is available yet for this article.
August 22, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30128638/enhancing-pharmacovigilance-capabilities-in-the-eu-regulatory-network-the-scope-joint-action
#10
Anna Radecka, Louise Loughlin, Mick Foy, Margarida Viana de Ferraz Guimaraes, Viola Macolic Sarinic, Marina Dimov Di Giusti, Marina Lesicar, Sabine Straus, Dolores Montero, Julia Pallos, Jelena Ivanovic, June Raine
In November 2013, a team of European regulators initiated the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action. Funded by the Health Programme of the European Union, and with contributions from the involved Member States, SCOPE gathered information and expertise on how regulators in Member States run their national pharmacovigilance systems to meet the requirements of the pharmacovigilance legislation that came into effect in June 2012. The SCOPE project evaluated then-current practices and developed tools to further improve the skills and capability in the pharmacovigilance network...
August 21, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30121742/the-social-impact-of-suspected-adverse-drug-reactions-an-analysis-of-the-canada-vigilance-spontaneous-reporting-database
#11
Genaro Castillon, Francesco Salvo, Yola Moride
INTRODUCTION: Some adverse drug reactions (ADRs) may involve direct social issues, such as impaired quality of life, work productivity, or social functioning, as opposed to being social consequences of medical adverse events. Data on ADRs with a direct social impact remain scarce in the literature. OBJECTIVE: Our objective was to describe the ADRs consisting of direct social issues that have been recorded in the Canadian national spontaneous reporting system (Canada Vigilance)...
August 19, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30121741/pomme-the-new-cohort-to-evaluate-long-term-effects-after-prenatal-medicine-exposure
#12
Justine Benevent, Caroline Hurault-Delarue, Mélanie Araujo, Jean-Louis Montastruc, Isabelle Lacroix, Christine Damase-Michel
INTRODUCTION: The POMME (PrescriptiOn Médicaments Mères Enfants) cohort has been implemented for the evaluation of the long-term consequences of medicine prenatal exposure. It holds anonymous medical information as well as information on medicine and healthcare reimbursement to the children, from the first day of intra-uterine life until childhood. OBJECTIVE: This article provides a description of the cohort regarding its structure and content and presents an outlook of the studies that could be performed with this new data source...
August 19, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30120741/evaluation-of-switching-patterns-in-fda-s-sentinel-system-a-new-tool-to-assess-generic-drugs
#13
Joshua J Gagne, Jennifer R Popovic, Michael Nguyen, Sukhminder K Sandhu, Patty Greene, Rima Izem, Wenlei Jiang, Zhong Wang, Yueqin Zhao, Andrew B Petrone, Anita K Wagner, Sarah K Dutcher
INTRODUCTION: Nearly 90% of drugs dispensed in the US are generic products. OBJECTIVE: The aim of this study was to develop and implement a tool for analyzing manufacturer-level drug utilization and switching patterns within the US Food and Drug Administration's Sentinel system. METHODS: A descriptive tool was designed to analyze data in the Sentinel common data model and was tested with two case studies-metoprolol extended release (ER) and lamotrigine ER-using claims data from four Sentinel data partners...
August 17, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30120740/authors-response-to-braillon-s-comment-on-limited-evidence-for-risk-factors-for-proarrhythmia-and-sudden-cardiac-death-in-patients-using-antidepressants-dutch-consensus-on-ecg-monitoring
#14
LETTER
Mirjam Simoons, Adrie Seldenrijk, Hans Mulder, Eric van Roon, Roberto Bakker, Henricus Ruhé
No abstract text is available yet for this article.
August 17, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30120739/comment-on-limited-evidence-for-risk-factors-for-proarrhythmia-and-sudden-cardiac-death-in-patients-using-antidepressants-dutch-consensus-on-ecg-monitoring
#15
LETTER
Alain Braillon
No abstract text is available yet for this article.
August 17, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30117051/the-prevalence-of-dose-errors-among-paediatric-patients-in-hospital-wards-with-and-without-health-information-technology-a-systematic-review-and-meta-analysis
#16
REVIEW
Peter J Gates, Sophie A Meyerson, Melissa T Baysari, Johanna I Westbrook
INTRODUCTION: The risk of dose errors is high in paediatric inpatient settings. Computerized provider order entry (CPOE) systems with clinical decision support (CDS) may assist in reducing the risk of dosing errors. Although a frequent type of medication error, the prevalence of dose errors is not well described. Dosing error rates in hospitals with or without CPOE have not been compared. OBJECTIVE: Our aim was to conduct a systematic review assessing the prevalence and impact of dose errors in paediatric wards with and without CPOE and/or CDS...
August 16, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30112729/stevens-johnson-syndrome-and-toxic-epidermal-necrolysis-in-association-with-commonly-prescribed-drugs-in-outpatient-care-other-than-anti-epileptic-drugs-and-antibiotics-a-population-based-case-control-study
#17
Noel Frey, Michael Bodmer, Andreas Bircher, Susan S Jick, Christoph R Meier, Julia Spoendlin
INTRODUCTION: Stevens-Johnson syndrome and toxic epidermal necrolysis have been associated with the use of various drugs, but evidence is scarce. We studied the association between new use of outpatient drugs other than anti-epileptic drugs and antibiotics and Stevens-Johnson syndrome and toxic epidermal necrolysis. METHODS: We conducted a matched (1:4) case-control analysis in 480 previously validated Stevens-Johnson syndrome/toxic epidermal necrolysis cases (1995-2013)...
August 16, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30112728/a-critical-evaluation-of-safety-signal-analysis-using-algorithmic-standardised-meddra-queries
#18
Carolyn Tieu, Christopher D Breder
INTRODUCTION: Algorithmic Standardised MedDRA® Queries (aSMQs) are increasingly used to enhance the efficiency of safety signal detection. The manner that aSMQs affect capture of potential safety cases is unclear. OBJECTIVES: Our objective was to characterise the performance of aSMQs with respect to their potential for double counting, the likelihood of events in aSMQ positive cases being clinically related, how frequently terms are used for algorithmically positive cases, and the face validity of positive cases based on the drug inducing events...
August 16, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30066315/effect-of-lawyer-submitted-reports-on-signals-of-disproportional-reporting-in-the-food-and-drug-administration-s-adverse-event-reporting-system
#19
James R Rogers, Ameet Sarpatwari, Rishi J Desai, Justin M Bohn, Nazleen F Khan, Aaron S Kesselheim, Michael A Fischer, Joshua J Gagne, John G Connolly
INTRODUCTION: Lawyer-submitted reports may have unintended consequences on safety signal detection in spontaneous adverse event reporting systems. OBJECTIVE: Our objective was to assess the impact of lawyer-submitted reports primarily for one adverse event (AE) on the ability to detect a signal of disproportional reporting for another AE for the same drug in the US FDA Adverse Event Reporting System (FAERS). METHODS: FAERS reports from January 2004 to September 2015 were used to estimate yearly cumulative proportional reporting ratios (PRRs) for three known drug-AE pairs-isotretinoin-birth defects, atorvastatin-rhabdomyolysis, and rosuvastatin-rhabdomyolysis-with and without lawyer-submitted reports...
August 1, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30066314/comment-on-using-human-experiments-of-nature-to-predict-drug-safety-issues-an-example-with-pcsk9-inhibitors
#20
LETTER
Lucas D Ward, Graeme J Moffat, Jing Yuan, Paul Nioi
No abstract text is available yet for this article.
July 31, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
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