Drug Safety
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#2Mohamed A. Elhawary (Ain Shams University)
Last. Islam N. Ali (Glas.: University of Glasgow)
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#1Joseph E Blais (HKU: University of Hong Kong)H-Index: 3
#2Yue Wei (HKU: University of Hong Kong)
Last. Ian C. K. Wong (UCL: University College London)H-Index: 69
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#1John W. Day (Stanford University)H-Index: 59
#2Jerry R. Mendell (OSU: Ohio State University)H-Index: 96
Last. Deepa H. Chand (Novartis)H-Index: 3
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INTRODUCTION This is the first description of safety data for intravenous onasemnogene abeparvovec, the only approved systemically administered gene-replacement therapy for spinal muscular atrophy. OBJECTIVE We comprehensively assessed the safety of intravenous onasemnogene abeparvovec from preclinical studies, clinical studies, and postmarketing data. METHODS Single-dose toxicity studies were performed in neonatal mice and juvenile or neonatal cynomolgus nonhuman primates (NHPs). Data presented...
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#1Elena Rocca (Uppsala Monitoring Centre)H-Index: 7
#2Oskar Gauffin (Uppsala Monitoring Centre)
Last. Birgitta Grundmark (Uppsala Monitoring Centre)H-Index: 4
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Introduction null The safety profile of remdesivir, conditionally approved for COVID-19, was limited at its 2020 introduction. Adverse drug reactions (ADRs) for medicines are collected in VigiBase, the WHO Global Database of Individual Case Safety Reports (ICSRs). null Objective null This study aimed to provide a descriptive analysis of COVID-19 ICSR data focusing on remdesivir, including a disproportionality analysis (DA) of ADRs. null Methods null A dedicated algorithm enabled retrieval of all...
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#1Sieta T. de Vries (UMCG: University Medical Center Groningen)H-Index: 11
#2Petra Denig (UMCG: University Medical Center Groningen)H-Index: 28
Last. Peter G. M. Mol (UMCG: University Medical Center Groningen)H-Index: 21
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INTRODUCTION Healthcare professionals (HCPs) and patients have various motives to report adverse drug reactions (ADRs) to their national agency. These motives may differ between countries. OBJECTIVE The aim of this study was to assess to what extent motives of HCPs and patients to report ADRs differ between countries. METHODS HCPs and patients from Croatia (HR), The Netherlands (NL), and the UK were asked to complete a web-based survey containing questions regarding demographics and ADR reportin...
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#1Toyotaka Iguchi (Pharmaceuticals and Medical Devices Agency)
#2Hikari Umeda (Pharmaceuticals and Medical Devices Agency)
Last. Daisaku Sato (Pharmaceuticals and Medical Devices Agency)
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INTRODUCTION: In mid-February, the nationwide immunization plan for the prevention of coronavirus disease 2019 (COVID-19) started in Japan (at first primarily focused on health professionals) using an mRNA-based vaccine (Pfizer/BioNTech). During the phase-in period from February to March, attention was focused on post-vaccination anaphylaxis and anaphylactoid symptoms from the viewpoint of ensuring the safety of the vaccination program. OBJECTIVE: The aim of this report was to provide an update ...
1 CitationsSource
#1Nicholas Moore (University of Bordeaux)H-Index: 65
#2Pauline Bosco-Levy (University of Bordeaux)H-Index: 7
Last. Cécile Droz-Perroteau (University of Bordeaux)H-Index: 10
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Background null Nonsteroidal anti-inflammatory drugs (NSAIDs) have been discouraged for the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections, fearing that they could increase the risk of infection or the severity of SARS-CoV-2. null Methods null Original studies providing information on exposure to NSAIDs and coronavirus disease 2019 (COVID-19) outcomes were retrieved and were included in a descriptive analysis and a meta-analysis with Cochrane Revue Manager (...
1 CitationsSource
#1Noha Iessa (WHO: World Health Organization)
#2Viola Macolić Šarinić (WHO: World Health Organization)H-Index: 5
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The Smart Safety Surveillance (3S) concept is based on the understanding that, when faced with competing pharmacovigilance priorities, countries will have to invest judiciously, by focusing on new priority products, sharing work and resources with other countries when possible and building national competence for those activities that cannot be delegated. The 3S principles were applied to Armenia, Brazil, Ethiopia, India, Peru and Thailand using three priority products: bedaquiline, rotavirus va...
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#1Rebekah Brennan (UCC: University College Cork)H-Index: 9
#2Mayyada Wazaify (UJ: University of Jordan)H-Index: 16
Last. Marie Claire Van Hout (University of Liverpool)H-Index: 20
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Non-steroidal anti-inflammatory drugs (NSAIDs) are among the most commonly used medications worldwide and have analgesic, antipyretic and anti-inflammatory properties. Although NSAIDs are recognised as generally safe and effective, non-medical and extra-medical use of these products can arise. Unlike use of illegal and many prescription drugs, which are subject to extensive research attention, inappropriate use of NSAIDs has been less well investigated. This scoping review collates and describes...
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#1Priya Bahri (European Medicines Agency)H-Index: 12
#2Daniel R. Morales (European Medicines Agency)H-Index: 21
Last. Sabine Straus (European Medicines Agency)H-Index: 3
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