journal

Drug Safety: An International Journal of Medical Toxicology and Drug Experience | Page 2

journal
https://read.qxmd.com/read/32248429/a-disproportionality-analysis-of-the-adverse-drug-events-associated-with-lurasidone-in-paediatric-patients-using-the-us-fda-adverse-event-reporting-system-faers
#21
LETTER
Kate E Rees, Te-Yuan Chyou, Prasad S Nishtala
No abstract text is available yet for this article.
April 4, 2020: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/32242310/safety-of-eosinophil-depleting-therapy-for-severe-eosinophilic-asthma-focus-on-benralizumab
#22
REVIEW
David J Jackson, Stephanie Korn, Sameer K Mathur, Peter Barker, Venkata G Meka, Ubaldo J Martin, James G Zangrilli
Eosinophils play a pivotal role in the inflammatory pathology of asthma and have been the target of new biologic treatments for patients with eosinophilic asthma. Given the central role of interleukin (IL)-5 in the eosinophil lifecycle, several therapies directed against the IL-5 pathway have been developed, including the anti-IL-5 antibodies mepolizumab and reslizumab and the IL-5 receptor α (IL-5Rα)-directed cytolytic antibody benralizumab. Eosinophil-depleting therapies represent a relatively new class of asthma treatment, and it is important to understand their long-term efficacy and safety...
April 2, 2020: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/32239447/enhancing-pharmacovigilance-in-sub-saharan-africa-through-training-and-mentoring-a-gsk-pilot-initiative-in-malawi
#23
Viviane Jusot, Frider Chimimba, Nettie Dzabala, Olga Menang, Joy Cole, Gregory Gardiner, Opokua Ofori-Anyinam, Olakunle Oladehin, Cecilia Sambakunsi, Mphatso Kawaye, Jens-Ulrich Stegmann, Yolanda Guerra Mendoza
INTRODUCTION: Pharmacovigilance (PV) systems to monitor drug and vaccine safety are often inadequate in sub-Saharan Africa. In Malawi, a PV enhancement initiative was introduced to address major barriers to PV. OBJECTIVE: The objective of this initiative was to improve reporting of adverse events (AEs) by strengthening passive safety surveillance via PV training and mentoring of local PV stakeholders and healthcare providers (HCPs) at their own healthcare facilities (HCFs)...
April 1, 2020: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/32212054/drug-safety-issues-covered-by-lay-media-a-cohort-study-of-direct-healthcare-provider-communications-sent-between-2001-and-2015-in-the-netherlands
#24
Esther de Vries, Petra Denig, Sieta T de Vries, Taco B M Monster, Jacqueline G Hugtenburg, Peter G M Mol
BACKGROUND: Some drug safety issues communicated through direct healthcare professional communications (DHPCs) receive substantial media coverage, while others do not. OBJECTIVES: The objective of this study was to assess the extent of coverage of drug safety issues that have been communicated through DHPCs in newspapers and social media. A secondary aim was to explore which determinants may be associated with media coverage. METHODS: Newspaper articles covering drug safety issues communicated through 387 DHPCs published between 2001 and 2015 were retrieved from LexisNexis Academic™...
March 24, 2020: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/32180134/rates-and-costs-of-dispensing-naloxone-to-patients-at-high-risk-for-opioid-overdose-in-the-united-states-2014-2018
#25
Rachel E Barenie, Joshua J Gagne, Aaron S Kesselheim, Ajinkya Pawar, Angela Tong, Jing Luo, Brian T Bateman
INTRODUCTION: Clinical practice guidelines recommend co-prescribing naloxone to patients at high risk of opioid overdose, but few such patients receive naloxone. High costs of naloxone may contribute to limited dispensing. OBJECTIVE: The aim of this study was to evaluate rates and costs of dispensing naloxone to patients receiving opioid prescriptions and at high risk for opioid overdose. METHODS: Using claims data from a large US commercial insurance company, we conducted a retrospective cohort study of new opioid initiators between January 2014 and December 2018...
March 16, 2020: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/32166617/patterns-of-inpatient-antibiotic-use-among-public-hospitals-in-hong-kong-from-2000-to-2015
#26
Celine S L Chui, Benjamin J Cowling, Wey Wen Lim, Christopher K M Hui, Esther W Chan, Ian C K Wong, Peng Wu
BACKGROUND: Studies have demonstrated that higher rates of antibiotic resistance are found in countries with higher antibiotic consumption. The global increase in antibiotic consumption is a major public health concern. OBJECTIVES: The objective of this study was to describe the antibiotic dispensing patterns in public hospitals in Hong Kong from 2000 to 2015. METHODS: We acquired data on all hospital admissions with any antibiotics dispensed from 2000 to 2015 from the Hong Kong public hospitals...
March 12, 2020: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/32166616/isop-fellowships-recognising-contributions-to-the-goals-of-isop
#27
EDITORIAL
Deirdre McCarthy, Mira Harrison-Woolrych
No abstract text is available yet for this article.
March 12, 2020: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/32146702/fluoroquinolone-induced-photosensitivity-a-chemical-fragment-based-approach-by-a-case-non-case-study-in-vigibase-%C3%A2
#28
Yoann Zelmat, Vanessa Rousseau, Leila Chebane, Jean-Louis Montastruc, Haleh Bagheri, Agnès Sommet
INTRODUCTION: Fluoroquinolones are widely used to treat bacterial infections. Many in vitro and in vivo studies have established a chemical relationship between fluoroquinolones' particular chemical structure and photosensitivity. The aim of this study was to establish a relationship between the chemical structure of fluoroquinolones and the risk of photosensitivity adverse effects from real-world data. METHODS: All the Individual Case Safety Reports (ICSRs) related to fluoroquinolones and registered in the World Health Organization global database (VigiBase® ) up to December 31, 2017 were collected...
March 7, 2020: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/32125666/prevalence-and-nature-of-medication-errors-and-medication-related-harm-following-discharge-from-hospital-to-community-settings-a-systematic-review
#29
REVIEW
Fatema A Alqenae, Douglas Steinke, Richard N Keers
BACKGROUND: Little is known about the epidemiology of medication errors and medication-related harm following transition from secondary to primary care. This systematic review aims to identify and critically evaluate the available evidence on the prevalence and nature of medication errors and medication-related harm following hospital discharge. METHODS: Studies published between January 1990 and March 2019 were searched across ten electronic databases and the grey literature...
March 3, 2020: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/32248428/systemic-adverse-events-associated-with-compounded-topical-pain-products
#30
LETTER
Jenny Kim, Karen Konkel, S Christopher Jones, Lynda McCulley
No abstract text is available yet for this article.
May 2020: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31863282/hypoglycemia-associated-with-antibiotics-alone-and-in-combination-with-sulfonylureas-and-meglitinides-an-epidemiologic-surveillance-study-of-the-fda-adverse-event-reporting-system-faers
#31
Kaitlin E Kennedy, Chengwen Teng, Taylor M Patek, Christopher R Frei
INTRODUCTION: Fluoroquinolones, clarithromycin, linezolid, tigecycline, cefditoren, doxycycline, and trimethoprim-sulfamethoxazole are known to be associated with hypoglycemia, but few studies have considered concomitant glucose-lowering medications. OBJECTIVE: The objective of this study was to evaluate the association between hypoglycemia and antibiotics using the US Food and Drug Administration Adverse Event Reporting System (FAERS), while accounting for concomitant glucose-lowering medications including sulfonylureas and meglitinides...
April 2020: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/32124266/identifying-drugs-inducing-prematurity-by-mining-claims-data-with-high-dimensional-confounder-score-strategies
#32
Romain Demailly, Sylvie Escolano, Françoise Haramburu, Pascale Tubert-Bitter, Ismaïl Ahmed
BACKGROUND: Pregnant women are largely exposed to medications. However, knowledge is lacking about their effects on pregnancy and the fetus. OBJECTIVE: This study sought to evaluate the potential of high-dimensional propensity scores and high-dimensional disease risk scores for automated signal detection in pregnant women from medico-administrative databases in the context of drug-induced prematurity. METHODS: We used healthcare claims and hospitalization discharges of a 1/97th representative sample of the French population...
March 2, 2020: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31721138/prenatal-exposure-to-macrolides-and-risk-of-congenital-malformations-a-meta-analysis
#33
REVIEW
Narmeen Mallah, Hamid Reza Tohidinik, Mahyar Etminan, Adolfo Figueiras, Bahi Takkouche
INTRODUCTION: Macrolides are widely used during pregnancy; however, their fetal safety remains uncertain. We performed a meta-analysis to assess the relation between prenatal exposure to macrolides and occurrence of congenital malformations. METHODS: We searched MEDLINE, EMBASE, and other databases until June 12, 2019. We assessed the quality of the studies and checked for heterogeneity and publication bias. We performed three different analyses and compared the effect of macrolides with each of the following unexposed populations: Group 1: babies unexposed to any medicine before birth, Group 2: babies exposed to non-macrolide antibiotics/non-teratogens, and Group 3: mixed population of the first and second comparators...
March 2020: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/32112228/leveraging-human-genetics-to-identify-safety-signals-prior-to-drug-marketing-approval-and-clinical-use
#34
Rebecca N Jerome, Meghan Morrison Joly, Nan Kennedy, Jana K Shirey-Rice, Dan M Roden, Gordon R Bernard, Kenneth J Holroyd, Joshua C Denny, Jill M Pulley
INTRODUCTION: When a new drug or biologic product enters the market, its full spectrum of side effects is not yet fully understood, as use in the real world often uncovers nuances not suggested within the relatively narrow confines of preapproval preclinical and trial work. OBJECTIVE: We describe a new, phenome-wide association study (PheWAS)- and evidence-based approach for detection of potential adverse drug effects. METHODS: We leveraged our established platform, which integrates human genetic data with associated phenotypes in electronic health records from 29,722 patients of European ancestry, to identify gene-phenotype associations that may represent known safety issues...
February 28, 2020: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/32048185/sex-differences-in-adverse-drug-reactions-of-metformin-a-longitudinal-survey-study
#35
Sieta T de Vries, Petra Denig, Corine Ekhart, Peter G M Mol, Eugene P van Puijenbroek
INTRODUCTION: In general, women more often experience metformin-associated adverse drug reactions (ADRs) than men. OBJECTIVES: We aimed to assess whether sex differences in reported ADRs for metformin are observed at different times after initiation, and to explore their concurrence with sex differences in the dose of metformin over time. This may guide future studies in assessing the involved mechanisms of sex differences in metformin-associated ADRs and may guide sex-specific management of ADRs in clinical practice...
February 11, 2020: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/32034700/benzodiazepine-use-and-risk-of-acute-angle-closure-glaucoma-a-population-based-case-crossover-study
#36
Woo Jung Kim, Junqing Li, In-Sun Oh, Inmyung Song, Eun Lee, Kee Namkoong, Ju-Young Shin
INTRODUCTION: Theoretically, benzodiazepines (BZDs) can narrow the iridocorneal angle and induce acute angle-closure glaucoma (AACG). However, little evidence exists regarding this association. OBJECTIVE: The objective of this study was to assess whether the use of BZDs is associated with the risk of AACG. METHODS: We conducted a population-based case-crossover study using the nationwide claims database of the National Health Insurance Service in Korea...
February 7, 2020: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/32020559/investigating-overlap-in-signals-from-evdas-faers-and-vigibase-%C3%A2
#37
Ulrich Vogel, John van Stekelenborg, Brian Dreyfus, Anju Garg, Marian Habib, Romana Hosain, Antoni Wisniewski
INTRODUCTION: The Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and VigiBase® are two established databases for safety monitoring of medicinal products, recently complemented with the EudraVigilance Data Analysis System (EVDAS). OBJECTIVE: Signals of disproportionate reporting (SDRs) can characterize the reporting profile of a drug, accounting for the distribution of all drugs and all events in the database. This study aims to quantify the redundancy among the three databases when characterized by two disproportionality-based analyses (DPA)...
February 4, 2020: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/32020558/quality-of-reporting-on-the-evaluation-of-risk-minimization-programs-a-systematic-review
#38
REVIEW
Andrea M Russell, Elaine H Morrato, Rebecca M Lovett, Meredith Y Smith
INTRODUCTION: Risk minimization programs are interventions mandated by regulatory agencies to ensure that benefits of pharmaceutical products outweigh risks. Many regulatory agencies require programs be evaluated for effectiveness; however, the quality of evidence has limited the ability to definitively determine if programs improve drug safety. OBJECTIVE: The aim of this systematic review was to assess and describe the current status of reporting on the effectiveness of pharmaceutical risk management programs...
February 4, 2020: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/32008183/disproportionality-analysis-for-pharmacovigilance-signal-detection-in-small-databases-or-subsets-recommendations-for-limiting-false-positive-associations
#39
Ola Caster, Yasunori Aoki, Lucie M Gattepaille, Birgitta Grundmark
INTRODUCTION: Uncovering safety signals through the collection and assessment of individual case reports remains a core pharmacovigilance activity. Despite the widespread use of disproportionality analysis in signal detection, recommendations are lacking on the minimum size of databases or subsets of databases required to yield robust results. OBJECTIVE: This study aims to investigate the relationship between database size and robustness of disproportionality analysis, with regards to limiting spurious associations...
February 1, 2020: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/31673951/new-discoveries-and-updates-on-cutaneous-adverse-drug-reactions-presented-at-the-24th-world-congress-of-dermatology-milan-italy-2019
#40
Felix L Chan, Neil H Shear, Nidhi Shah, Cristina Olteanu, Rena Hashimoto, Roni P Dodiuk-Gad
No abstract text is available yet for this article.
February 2020: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
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