Discover scientific publications on pharmacovigilance
Original research and thinking in the science of pharmacovigilance
This is a non-exhaustive list of scientific papers with key authors from the UMC. Most of the references link to full articles.
224 documents found.
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Scientific publications
The Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Development and Statement
Drug Saf 47, 575–584 (2024). https://doi.org/10.1007/s40264-024-01421-9
Author: Fusaroli, M., Salvo, F., Begaud, B. et al
Date: 2024-08-14 -
Scientific publications
The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS‑PV): Explanation and Elaboration
Drug Saf 47, 585–599 (2024). https://doi.org/10.1007/s40264-024-01423-7
Author: Fusaroli, M., Salvo, F., Begaud, B. et al
Date: 2024-08-14 -
Scientific publications
Methods for Signal Management Using the Global Safety Database VigiBase
Chinese Journal of Pharmacovigilance, 2024, Vol. 21, No. 7: 836–840. DOI: 10.19803/j.1672-8629.20240373
Author: Peter Hjelmström, Geoffrey Bowring, Qun-Ying Yue, Niklas Norén G.
Date: 2024-07-31 -
Scientific publications
Traversing the social media landscape: Digital health communications in 2024
Medical Writing. 2024;33(2):74–8. https://doi.org/10.56012/gsrj5809
Author: Shannen Young
Date: 2024-07-03 -
Scientific publications
Data-Driven Identification of Factors That Influence the Quality of Adverse Event Reports: 15-Year Interpretable Machine Learning and Time-Series Analyses of VigiBase and QUEST
JMIR Med Inform, Vol 12, 2024. doi: 10.2196/49643
Author: Sim Mei Choo, Daniele Sartori, Sing Chet Lee, Hsuan-Chia Yang & Shabbir Syed-Abdul
Date: 2024-04-03 -
Scientific publications
A Comparison of Signals of Designated Medical Events and Non-designated Medical Events: Results from a Scoping Review
Drug Safety, Vol 47, p475–485 (2024). https://doi.org/10.1007/s40264-024-01403-x
Author: Daniele Sartori, Jeffrey K. Aronson, Nils Erlanson, G. Niklas Norén & Igho J. Onakpoya
Date: 2024-02-24 -
Scientific publications
Dabigatran‑related serious medication errors: an analysis using datafrom VigiBase
European Journal of Clinical Pharmacology (2024), published online 29 January 2024. https://doi.org/10.1007/s00228-024-03629-1
Author: Qingxia Zhang, Qian Ding & Qun‑Ying Yue
Date: 2024-01-29 -
Scientific publications
Conducting and interpreting disproportionality analyses derived from spontaneous reporting systems
Frontiers in Drug Safety and Regulation, Vol 3, 2024 (DOI=10.3389/fdsfr.2023.1323057)
Author: Cutroneo, Paola Maria; Sartori, Daniele; Tuccori, Marco; et al
Date: 2024-01-26 -
Scientific publications
Supporting Pharmacovigilance Signal Validation and Prioritization with Analyses of Routinely Collected Health Data: Lessons Learned from an EHDEN Network Study
Drug Saf (2023). https://doi.org/10.1007/s40264-023-01353-w
Author: Gauffin, O., Brand, J.S., Vidlin, S.H. et al.
Date: 2023-10-07 -
Scientific publications
Strengthening the Pharmacovigilance System in Mexico: Implementation of VigiFlow and VigiLyze, as ICSR and Signal Detection Management Systems
Pharmaceutical Medicine, 2023
Author: Rayón-Ramírez, G., Alvarado-López, S., Camacho-Sandoval, R. et al.
Date: 2023-10-07 -
Scientific publications
Communicating for the Safe Use of Medicines: Progress and Directions for the 2020s
Promoted by the Special Interest Group of the International Society of Pharmacovigilance. Drug Saf 46, 517–532 (2023). https://doi.org/10.1007/s40264-023-01285-5
Author: Priya Bahri et al
Date: 2023-05-01 -
Scientific publications
Computational methods and systems to support decision making in pharmacovigilance (editorial)
Frontiers in Drug Safety and Regulation, Vol. 3, 2023
Author: Taxiarchis Botsis, Robert Ball, G. Niklas Norén
Date: 2023-04-21 -
Scientific publications
Vulval Aphthous Ulcers in Adolescents Following COVID-19 Vaccination - Analysis of an international case series
Journal of Pediatric and Adolescent Gynecology, published online 17 March 2023
Author: Annette Rudolph, Ruth Savage
Date: 2023-03-17 -
Scientific publications
Global safety monitoring of COVID-19 vaccines: how pharmacovigilance rose to the challenge
Therapeutic Advances in Drug Safety. Volume: 13. Article first published online: August 25, 2022; Issue published: January - December, 2022.
Author: Annette Rudolph, Joseph Mitchell, Jim Barrett, Helena Sköld, Henric Taavola, Nils Erlanson, Carlos Melgarejo-González, Qun-Ying Yue
Date: 2022-08-25 -
Scientific publications
Fatal adverse events of rivaroxaban combined with aspirin: an analysis using data from VigiBase
European Journal of Clinical Pharmacology (2022)
Author: Qingxia Zhang, Qian Ding, Suying Yan & Qun-Ying Yue
Date: 2022-07-01 -
Scientific publications
Montelukast and Nightmares: Further Characterisation Using Data from VigiBase
Drug Safety 2022
Author: Sarah Watson, Elenor Kaminsky, Henric Taavola, Marian Attalla and Qun Ying Yue
Date: 2022-06-03 -
Scientific publications
Automated Drug Coding Using Artificial Intelligence: An Evaluation of WHODrug Koda on Adverse Event Reports
Drug Safety, Vol 45, p549–561 (2022)
Author: Eva-Lisa Meldau, Shachi Bista, Emma Rofors & Lucie M. Gattepaille
Date: 2022-05-17 -
Scientific publications
Indapamide-Induced Rhabdomyolysis: An Evaluation of Case Reports in VigiBase Using the Bradford Hill Criteria
Drugs - Real World Outcomes, 2022
Author: Qun-Ying Yue, Pia Caduff Janosa
Date: 2022-03-04 -
Scientific publications
Post-Marketing Safety Profile of Vortioxetine Using a Cluster Analysis and a Disproportionality Analysis of Global Adverse Event Reports
Drug Saf (2022). https://doi.org/10.1007/s40264-021-01139-y
Author: Corine Ekhart, Florence van Hunsel, Eugène van Puijenbroek, Rebecca Chandler, Eva-Lisa Meldau, Henric Taavola & G. Niklas Norén
Date: 2022-01-12 -
Scientific publications
Fatal adverse events of dabigatran combined with aspirin in elderly patients: An analysis using data from VigiBase
Frontiers in Pharmacology, section Cardiovascular and Smooth Muscle Pharmacology, 22 December 2021 | https://doi.org/10.3389/fphar.2021.769251
Author: Qingxia Zhang, Qian Ding, Suying Yan and Qun-Ying Yue
Date: 2021-12-21 -
Scientific publicationsConsensus clustering for case series identification and adverse event profiles in pharmacovigilance
Artificial Intelligence In Medicine. Volume 122, December 2021, 102199
Author: G. Niklas Norén, Eva-Lisa Meldau, Rebecca E. Chandler
Date: 2021-11-15 -
Scientific publicationsAppendicitis as a possible safety signal for the COVID-19 vaccines
Vaccine: X. Volume 9, December 2021, 100122
Author: Joseph Mitchell, Qun-Ying Yue
Date: 2021-11-15 -
Scientific publications
The International Society of Pharmacovigilance (ISoP) Pharmacogenomic Special Interest Group: Pharmacogenomics in Pharmacovigilance
Drug Safety (2021)
Author: Qun-Ying Yue
Date: 2021-05-08 -
Scientific publications
Characterization of VigiBase reports on tinnitus associated with bisoprolol—An exploratory and descriptive study
Pharmacol Res Perspect. 2021 Jun; 9(3): e00780. Published online 2021 May 6. doi: 10.1002/prp2.780
Author: Sarah Watson, Henric Taavola, Marian Attalla, Elenor Kaminsky, and Quin‐Ying Yue
Date: 2021-05-06 -
Scientific publications
Vaccination against COVID-19: insight from arterial and venous thrombosis occurrence using data from VigiBase
European Respiratory Journal 2021; DOI: 10.1183/13993003.00956-2021
Author: David M. Smadja, Qun-Ying Yue, Richard Chocron, Olivier Sanchez, Agnes Lillo-Le Louet
Date: 2021-04-16 -
Scientific publications
Progress in Immunization Safety Monitoring — Worldwide, 2010–2019
CDC Morbidity and Mortality Weekly Report (MMWR) April 16, 2021
Author: Omar Salman, Katherine Topf, Rebecca Chandler, Laura Conklin
Date: 2021-04-16 -
Scientific publications
The Use of Subgroup Disproportionality Analyses to Explore the Sensitivity of a Global Database of Individual Case Safety Reports to Known Pharmacogenomic Risk Variants Common in Japan
Drug Safety
Author: Rika Wakao, Ingrid M. Lönnstedt, Yasunori Aoki, Rebecca E. Chandler
Date: 2021-04-10 -
Scientific publications
Multisystem inflammatory syndrome in children and adults (MIS-C/A): Case definition & guidelines for data collection, analysis, and presentation of immunization safety data
Vaccine (Elsevier)
Author: Tiphanie P. Vogel, Karina A. Top, Christos Karatzios, David C. Hilmers, Lorena I. Tapia, Pamela Moceri, Lisa Giovannini-Chami, Nicholas Wood, Rebecca E. Chandler, Nicola P. Klein, Elizabeth P. Schlaudecker, M. Cecilia Poli, Eyal Muscal, Flor M.Munoz
Date: 2021-03-12 -
Scientific publications
How far can we go with just out-of-the-box BERT models?
Computational Linguistics, December 2020
Author: Lucie M. Gattepaille
Date: 2020-12-15 -
Scientific publications
Tumor necrosis factor inhibitor-induced pleuropericarditis: A retrospective evaluation using data from VigiBase
International Immunopharmacology. Volume 89, Part A, December 2020, 107049
Author: Qingxia Zhang, Qun-Ying Yue
Date: 2020-12-01 -
Scientific publications
How to ensure we can track and trace global use of COVID-19 vaccines?
Vaccine, Volume 39, Issue 2, 8 January 2021, Pages 176-179
Author: Robert H. Vander Stichele, Christian Hay, Malin Fladvad, Miriam C.J.M. Sturkenboom, Robert T. Chen
Date: 2020-11-24 -
Scientific publications
Electronic Reporting Systems in Pharmacovigilance: The Implementation of VigiFlow in Brazil
Pharmaceutical Medicine volume 34, pages327–334(2020) (leading article)
Author: Vogler M, Ricci Conesa H, de Araújo Ferreira K, Moreira Cruz F, Simioni Gasparotto F, Fleck K, Maciel Rebelo F, Kollross B, Silveira Gonçalves Y.
Date: 2020-09-15 -
Scientific publications
Sex Differences in Reported Adverse Drug Reactions to COVID-19 Drugs in a Global Database of Individual Case Safety Reports
Drug Safety vol. 43, pages 1309–1314 (2020)
Author: Alem Zekarias, Sarah Watson, Sara Hedfors Vidlin & Birgitta Grundmark
Date: 2020-09-01 -
Scientific publications
Signals of adverse drug reactions communicated by pharmacovigilance stakeholders: protocol for a scoping review of the global literature
Systematic Reviews volume 9, Article number: 180 (2020)
Author: Sartori D, Aronson JK, Onakpoya IJ.
Date: 2020-08-13 -
Scientific publications
E-Learning in Pharmacovigilance: An Evaluation of Microlearning-Based Modules Developed by Uppsala Monitoring Centre
Drug Safety volume 43, pages 1171–1180(2020)
Author: Hegerius A, Caduff-Janosa P, Savage R, Ellenius J.
Date: 2020-08-13 -
Scientific publications
A Feasibility Study of Drug–Drug Interaction Signal Detection in Regular Pharmacovigilance
Drug Safety 43, pages 775–785 (2020)
Author: Sara Hult, Daniele Sartori, Tomas Bergvall, Sara Hedfors Vidlin, Birgitta Grundmark, Johan Ellenius & G. Niklas Norén
Date: 2020-07-17 -
Scientific publications
Interstitial Lung Disease as an Adverse Drug Reaction in Japan: Exploration of Regulatory Actions as a Basis for High Reporting
Drug Safety, vol 43, pages 1121–1131 (2020)
Author: Eiko Iwasa, Yu Fujiyoshi, Yuki Kubota, Ryota Kimura, Rebecca E. Chandler, Henric Taavola, G. Niklas Norén & Rika Wakao
Date: 2020-07-03 -
Scientific publications
Nintedanib and ischemic colitis: Signal assessment with the integrated use of two types of real-world evidence, spontaneous reports of suspected adverse drug reactions, and observational data from large health-care databases
Pharmacoepidemiol Drug Saf. 2020 May 12. doi: 10.1002/pds.5022
Author: Chandler RE
Date: 2020-06-25 -
Scientific publications
Communicating Adverse Drug Reaction Insights Through Patient Organizations: Experiences from a Pilot Study in the Netherlands
Drug Saf. 2020 May 16. doi: 10.1007/s40264-020-00932-5.
Author: Härmark L, Weits G, Meijer R, Santoro F, Norén GN, van Hunsel F.
Date: 2020-06-25 -
Scientific publications
Prospective Evaluation of Adverse Event Recognition Systems in Twitter: Results from the Web-RADR Project
Drug Saf. 2020 May 14. doi: 10.1007/s40264-020-00942-3
Author: Gattepaille LM, Hedfors Vidlin S, Bergvall T, Pierce CE, Ellenius J
Date: 2020-06-25 -
Scientific publications
Drug Safety in Geriatric Patients: Current Status and Proposed Way Forward
Drug Saf. 2020 Jun 4. doi: 10.1007/s40264-020-00949-w
Author: Furlan G, Caduff-Janosa P, Sottosanti L, Cappello E, Valdiserra G, Tuccori M.
Date: 2020-06-25 -
Scientific publications
Risk Factor Considerations in Statistical Signal Detection: Using Subgroup Disproportionality to Uncover Risk Groups for Adverse Drug Reactions in VigiBase
Drug Saf. 2020 Jun 20. doi: 10.1007/s40264-020-00957-w.
Author: Sandberg L, Taavola H, Aoki Y, Chandler R, Norén GN.
Date: 2020-06-20 -
Scientific publications
Optimizing safety surveillance for COVID-19 vaccines
Nat Rev Immunol. 2020 Jun 17:1–2. doi: 10.1038/s41577-020-0372-8.
Author: Chandler RE
Date: 2020-06-17 -
Scientific publications
Exome Sequencing Reveals Common and Rare Variants in F5 Associated With ACE Inhibitor and Angiotensin Receptor Blocker–Induced Angioedema
Clin Pharmacol Ther. 2020Dec;108(6):1195-1202. doi: 10.1002/cpt.1927. Epub 2020 Jul 18. PMID: 32496628.
Author: Maroteau C, Siddiqui MK, Veluchamy A, et al
Date: 2020-06-04 -
Scientific publications
The Role of Pharmacovigilance and ISoP During the Global COVID-19 Pandemic
Drug Saf. 2020 Jun;43(6):511-512. doi: 10.1007/s40264-020-00941-4
Author: Chandler RE, McCarthy D, Delumeau JC, Harrison-Woolrych M
Date: 2020-05-07 -
Scientific publications
Genome-wide association study of angioedema induced by angiotensin-converting enzyme inhibitor and angiotensin receptor blocker treatment.
The Pharmacogenomics Journal volume 20, pages770–783(2020)
Author: Eva Rye Rasmussen, Pär Hallberg, et al
Date: 2020-02-21 -
Scientific publications
WHODrug: A Global, Validated and Updated Dictionary for Medicinal Information
Ther Innov Regul Sci. 2020 Feb 20. doi: 10.1007/s43441-020-00130-6
Author: Lagerlund O, Strese S, Fladvad M, Lindquist M
Date: 2020-02-20 -
Scientific publications
Pneumonia may be more frequent and have more fatal outcomes with clozapine than with other second‐generation antipsychotics
World Psychiatry. 2020 Feb; 19(1): 120–121. Published online 2020 Jan 10. doi: 10.1002/wps.20707
Author: Jose de Leon, Emilio J. Sanz, G. Niklas Norén, and Carlos De las Cuevas
Date: 2020-02-03 -
Scientific publications
Disproportionality Analysis for Pharmacovigilance Signal Detection in Small Databases or Subsets: Recommendations for Limiting False-Positive Associations
Drug Safety (2020) 43:479–487.
Author: Ola Caster, Yasunori Aoki, Lucie M. Gattepaille & Birgitta Grundmark
Date: 2020-02-01 -
Scientific publications
Adverse Events in Twitter - Development of a Benchmark Reference Dataset: Results from IMI WEB-RADR
Drug Safety vol. 43, pages 467–478 (2020)
Author: Juergen Dietrich, Lucie M. Gattepaille, Britta Anne Grum, Letitia Jiri, Magnus Lerch, Daniele Sartori & Antoni Wisniewski
Date: 2020-01-29 -
Scientific publications
Data-Driven Identification of Adverse Event Reporting Patterns for Japan in VigiBase, the WHO Global Database of Individual Case Safety Reports
Drug Safety, Vol. 42, 1487–1498 (2019)
Author: Rika Wakao, Henric Taavola, Lovisa Sandberg, Eiko Iwasa, Saori Soejima, Rebecca Chandler & G. Niklas Norén
Date: 2019-12-02 -
Scientific publications
Reported adverse drug reactions in women and men: Aggregated evidence from globally collected individual case reports during half a century
EClinicalMedicine. 2019 Oct 25;17:100188
Author: Watson S, Caster O, Rochon PA, den Ruijter H
Date: 2019-10-25 -
Scientific publications
Pharmacovigilance as Scientific Discovery: An Argument for Trans-Disciplinarity
Promoting a trans-disciplinary approach to pharmacovigilance is a long-term effort that requires structural changes in medical education, research, and enterprise. The authors suggest changes, discuss to what extent they are already in process, and indicate the advantages from both epistemological and ethical perspectives.
Author: Elena Rocca, Samantha Copeland, I. Ralph Edwards
Date: 2019-10-01 -
Scientific publications
Recommendations for the Use of Social Media in Pharmacovigilance: Lessons from IMI WEB-RADR
Drug Safety volume 42, pages 1393–1407 (2019)Key Points:General social media, as exemplified by sample data from Facebook and Twitter, are not recommended for broad statistical signal detection. Social media channels may provide a useful adjunct to pharmacovigilance activities in specific niche areas such as exposure during pregnancy and abuse/misuse of medicines. Future enhancement of adverse event recognition algorithms may broaden the scope and utility of social media over time.
Author: John van Stekelenborg, Johan Ellenius, Simon Maskell, Tomas Bergvall, Ola Caster et al
Date: 2019-08-24 -
Scientific publications
Using the WHO database of spontaneous reports to build joint vector representations of drugs and adverse drug reactions, a promising avenue for pharmacovigilance
Conference Proceedings of the IEEE 7th International Conference on Healthcare Informatics, Xi’an, China, 2019.
Author: Lucie Gattepaille
Date: 2019-06-28 -
Scientific publications
Modernising vaccine surveillance systems to improve detection of rare or poorly defined adverse events
BMJ 2019; 365 doi: https://doi.org/10.1136/bmj.l2268
Author: Rebecca Chandler
Date: 2019-05-31 -
Scientific publications
Studying the Evolving Knowledge of Adverse Drug Reactions in Order to Facilitate the Rational Use of Medicines in Paediatric Patients
Healthcare 2019, 7, 55.This paper uses historical safety problems in paediatric patients to illustrate how different data sources and methods in pharmacovigilance can contribute with valuable knowledge in order to facilitate rational use of medicines.
Author: Kristina Star and Imti Choonara
Date: 2019-04-18 -
Scientific publications
Paediatric safety signals identified in VigiBase: Methods and results from Uppsala Monitoring Centre
Pharmacoepidemiology and Drug Safety 2019, 10.1002/pds.4734, doi:10.1002/pds.4734.This describes how VigiBase was screened to identify signals in reports issued for children. Three of the eight identified signals have been added to the product label, providing new information for patients, caregivers and healthcare professionals to consider prior to and during therapy.
Author: Star K. Sandberg L. Bergvall T. Choonara I. Caduff-Janosa P. Edwards IR.
Date: 2019-02-25 -
Scientific publications
Increased risk for aseptic meningitis after amoxicillin or amoxicillin‐clavulanic acid in males
Pharmacoepidemiology & Drug Safety, 2019;28:389–395. The drug-ADR combination is well-accepted in the medical community, but the potential predisposition in males had not been previously reported. In researching potential explanations for this statistical observation, we found evidence of gender differences in immune responses, such as type 4 hypersensitivity responses, the mechanism of aseptic meningitis by amoxicillin.
Author: Rebecca Chandler
Date: 2018-12-17 -
Scientific publications
Benefit-Risk Assessment in Pharmacovigilance
This chapter provides an overview of the conceptualthinking behind present methods for benefit-risk assessment of medicines, with a more detailed description of some important approaches. Examples of real assessments are briefly presented. In: Bate A. (eds) Evidence-Based Pharmacovigilance. Methods in Pharmacology and Toxicology. Humana Press, New York, NY, 2018.
Author: Ola Caster
Date: 2018-11-08 -
Scientific publications
Assessment of the utility of social media for broad-ranging statistical signal detection in pharmacovigilance: Results from the WEB-RADR project
This paper is a distilled collection of analyses and results that were generated within the signal detection workstream of work package 2b of the WEB-RADR project over a period of about three years.Drug Saf (2018). https://doi.org/10.1007/s40264-018-0699-2
Author: Caster O, Dietrich J, Kürzinger ML. et al.
Date: 2018-08-16 -
Scientific publications
Letter to the Editor Regarding "Natalizumab-Associated Primary Central Nervous System Lymphoma"
World Neurosurgery, Volume 115, July 2018, Pages 473-474.
Author: D. Sartori, B. Grundmark
Date: 2018-06-26 -
Scientific publications
Letter to the Editor - Desogestrel and panic attacks – a new suspected adverse drug reaction reported by patients and health care professionals on spontaneous reports.
Br J Clin Pharma (2018) 84, 1858–1859.
Author: Sarah Watson, Linda Härmark
Date: 2018-05-24 -
Scientific publications
Characteristics, Quality and Contribution to Signal Detection of Spontaneous Reports of Adverse Drug Reactions Via the WEB-RADR Mobile Application: A Descriptive Cross-Sectional Study
Spontaneous reporting of suspected adverse drug reactions is key for efficient post-marketing safety surveillance. To increase usability and accessibility of reporting tools, the Web-Recognising Adverse Drug Reactions (WEB-RADR) consortium developed a smartphone application (app) based on a simplified reporting form.Drug Safety, Vol. 41, 969–978 (2018)
Author: Ingrid Oosterhuis, Henric Taavola, Philip M. Tregunno, Petar Mas, Sara Gama, Victoria Newbould, Ola Caster, Linda Härmark
Date: 2018-05-14 -
Scientific publications
Comment on “Safety of Human Papillomavirus Vaccines: An Updated Review”
A commentary/vision for the role of pharmacovigilance within the evolution of vaccinology in the 21st century.Drug Safety, May 2018, Volume 41, Issue 5, pp 537–538.
Author: Chandler RE, Edwards IR, Lindquist M.
Date: 2018-03-23 -
Scientific publications
Does patient reporting lead to earlier detection of drug safety signals? A retrospective comparison of time to reporting between patients and healthcare professionals in a global database.
Br J Clin Pharmacol (2018) 84, 1514–1524.
Author: Leàn Rolfes, Florence van Hunsel, Ola Caster, Henric Taavola, Katja Taxis, Eugène van Puijenbroek.
Date: 2018-03-09 -
Scientific publications
Pharmacovigilance in pediatrics
Thérapie, Vol 73, Issue 2, April 2018, p171-180.
Author: Bouquet É, Star K, Jonville-Béra AP, Durrieu G.
Date: 2018-02-16 -
Scientific publications
Serious Neurological Adverse Events after Ivermectin—Do They Occur beyond the Indication of Onchocerciasis?
The American Journal of Tropical Medicine and Hygiene, 2017
Author: Rebecca E. Chandler
Date: 2017-12-04 -
Scientific publications
Safety Concerns Reported by Patients Identified in a Collaborative Signal Detection Workshop using VigiBase: Results and Reflections from Lareb and Uppsala Monitoring Centre
Drug Safety. https://doi.org/10.1007/s40264-017-0594-2
Author: Watson, Sarah; Chandler, Rebecca E.; Taavola, Henric; Härmark, Linda; Grundmark, Birgitta; Zekarias, Alem; Star, Kristina; Hunsel, Florence van
Date: 2017-09-20 -
Scientific publications
Retrospective review of paediatric case reports of Stevens-Johnson syndrome and toxic epidermal necrolysis with lamotrigine from an international pharmacovigilance database.
This study aims to characterise paediatric reports with lamotrigine (LTG) and Stevens-Johnson syndrome or toxic epidermal necrolysis (SJS/TEN), and to explore whether potential risk factors can be identified.BMJ Paediatrics Open 2017;1:e000039. doi:10.1136/ bmjpo-2017-000039.
Author: Egunsola O, Star K, Juhlin K, et al.
Date: 2017-09-06 -
Scientific publications
Commentary: Safety Concerns with HPV Vaccines Continue to Linger: Are Current Vaccine Pharmacovigilance Practices Sufficient?
Novel approaches to vaccine pharmacovigilance are required to more fully understand this safety concern for HPV vaccines. This is a commentary on a report by Ozawa et al. of a case series of girls from Japan who experienced multiple symptoms suspected to be caused by the HPV vaccine.Drug Safety (2017). DOI 10.1007/s40264-017-0593-3
Author: Rebecca E. Chandler
Date: 2017-08-30 -
Scientific publications
A New Erice Report Considering the Safety of Medicines in the 21st Century
Two decades after the Erice Declaration on Communicating Drug Safety Information, a new group of experts in the science of the safety of medicines, met in Erice in September 2016 to review the original Declaration and to discuss what might be needed to update and strengthen its proposals for the new century.Drug Saf (2017). https://doi.org/10.1007/s40264-017-0571-9
Author: Edwards, I.R.
Date: 2017-08-17 -
Scientific publications
A method for data-driven exploration to pinpoint key features in medical data and facilitate expert review.
The paper describes the development of vigiPoint, a method for data-driven exploration in pharmacovigilance; and illustrates its use by identifying the key features of individual case safety reports related to medication errors.Pharmacoepidemiol Drug Saf. 2017;1–10.
Author: Juhlin K, Star K, Norén GN.
Date: 2017-08-16 -
Scientific publicationsvigiRank for statistical signal detection in pharmacovigilance: First results from prospective real-world use
vigiRank is a data-driven predictive model for emerging safety signals. In addition to disproportionate reporting patterns, it also accounts for the completeness, recency, and geographic spread of individual case reporting, as well as the availability of case narratives. Previous retrospective analysis suggested that vigiRank performed better than disproportionality analysis alone. The purpose of this analysis was to evaluate its prospective performance.Pharmacoepidemiol Drug Saf. 2017;26:1006–1010.
Author: Caster O, Sandberg L, Bergvall T, Watson S, Norén GN.
Date: 2017-06-27 -
Scientific publications
Letter: International Reports of Unexpected Low Plasma Concentrations of Dabigatran Suggest That More Frequent Measurements Will Add Value
A letter to the editor of ‘Seminars in Thrombosis & Hemostasis’ highlighting that "International reports of unexpected low plasma concentrations of dabigatran suggest that more frequent measurements will add value".Seminars in Thrombosis and Hemostasis. 2017; 43(06): 635-638.
Author: Savage, Ruth L., Castellano, Marilina, Tatley, Michael V.
Date: 2017-06-13 -
Scientific publications
Commentary: The Power of the Case Narrative - Can it be Brought to Bear on Duplicate Detection?
A commentary on the paper from US FDA on duplicate detection in the VAERS and FAERS databases.Drug Safety (2017) 40: 543.
Author: Norén, G.
Date: 2017-05-30 -
Scientific publications
Causality Assessment in Pharmacovigilance: Still a Challenge
Drug Saf (2017) 40:365–372. (May 2017, Volume 40, Issue 5, pp 365–372)
Author: I. Ralph Edwards
Date: 2017-02-28 -
Scientific publicationsCurrent Safety Concerns with Human Papillomavirus Vaccine: A Cluster Analysis of Reports in VigiBase
The aim of this study was to explore global reporting patterns for HPV vaccine for subgroups of reports with similar adverse event (AE) profiles.Drug Safety. January 2017, Volume 40, Issue 1, pp 81–90.
Author: Rebecca E. Chandler, Kristina Juhlin, Jonas Fransson, Ola Caster, I. Ralph Edwards, G. Niklas Norén.
Date: 2017-01-02 -
Scientific publicationsGood Signal Detection Practices : Evidence from IMI PROTECT
Over a period of 5 years, the Innovative Medicines Initiative PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium) project has addressed key research questions relevant to the science of safety signal detection. Drug Saf (2016) 39:469–490
Author: Antoni F. Z. Wisniewski, Andrew Bate, Cedric Bousquet, Andreas Brueckner, Gianmario Candore, Kristina Juhlin, Miguel A. Macia-Martinez, Katrin Manlik, Naashika Quarcoo, Suzie Seabroke, Jim Slattery, Harry Southworth, Bharat Thakrar, Phil Tregunno, Lionel Van Holle, Michael Kayser, G. Niklas Norén.
Date: 2016-06-01 -
Scientific publications
Adverse Drug Reaction Reporting in Africa and a Comparison of Individual Case Safety Report Characteristics Between Africa and the Rest of the World: Analyses of Spontaneous Reports in VigiBase®
Drug Saf (2016) 39: 335–345.
Author: Haggar H. Ampadu, Jarno Hoekman, Marieke L. de Bruin, Shanthi N. Pal, Sten Olsson, Daniele Sartori, Hubert G. M. Leufkens, Alexander N. O. Dodoo
Date: 2016-01-11 -
Scientific publications
Performance of Stratified and Subgrouped Disproportionality Analyses in Spontaneous Databases
Drug Safety (April 2016) Volume 39, Issue 4, pp 355–364.
Author: Suzie Seabroke, Gianmario Candore, Kristina Juhlin, Naashika Quarcoo, Antoni Wisniewski, Ramin Arani, Jeffery Painter, Philip Tregunno, G. Niklas Norén, Jim Slattery.
Date: 2016-01-09 -
Scientific publications
Pharmacovigilance is... Vigilance.
Drug Safety, April 2016, Volume 39, Issue 4, pp281–285.
Author: Edwards, I.R., Soulayamani Bencheikh, R.
Date: 2015-12-21 -
Scientific publicationsCheminformatics-aided pharmacovigilance: application to Stevens-Johnson Syndrome.
Quantitative Structure-Activity Relationship (QSAR) models can predict adverse drug reactions (ADRs), and thus provide early warnings of potential hazards. J Am Med Inform Assoc 2015;0:1–11. doi:10.1093/jamia/ocv127
Author: Yen S Low, Ola Caster, Tomas Bergvall, Denis Fourches, Xiaoling Zang, G Niklas Norén, Ivan Rusyn, Ralph Edwards, Alexander Tropsha.
Date: 2015-10-24 -
Scientific publicationsQuantitative benefit-risk assessment of methylprednisolone in multiple sclerosis relapses
High-dose short-term methylprednisolone is the recommended treatment in the management of multiple sclerosis relapses, although it has been suggested that lower doses may be equally effective. BMC Neurology (2015) 15:206
Author: Caster, Ola; Edwards, I. Ralph
Date: 2015-10-16 -
Scientific publicationsExperiences and Lessons from Implementing Cohort Event Monitoring Programmes for Antimalarials in Four African Countries: Results of a Questionnaire-Based Survey
Cohort event monitoring (CEM) is an intensive method of post-marketing surveillance for medicines safety. The method is based on prescription event monitoring, which began in the 1970s. Drug Saf (2015) 38:1115–1126.
Author: Suku, Comfort Kunak; Hill, Geraldine; Sabblah, George; Darko, Mimi; Muthuri, Abwao, George Edward; Pandit, Jayesh; Osakwe, Adeline Ijeoma; Elagbaje, Cassandra; Nyambayo, Priscilla; Khoza, Star; Dodoo, Alexander N.; Pal, Shanthi Narayan
Date: 2015-08-13 -
Scientific publications
Pharmacovigilance in resource-limited countries.
Expert Rev Clin Pharmacol, 2015. 8(4), 449–460.
Author: Olsson, S., Pal, S.N., Dodoo, A.
Date: 2015-06-03 -
Scientific publicationsPharmacovigilance in resource limited countries
In the past 20 years, many low- and middle-income countries have created national pharmacovigilance systems and joined the WHO’s global network.Expert Review of Clinical Pharmacology, 2015; 8:4, 449-460.
Author: Sten Olsson, Shanthi N Pal, Alex Dodoo
Date: 2015-06-03 -
Scientific publicationsThe ISoP CommSIG for Improving Medicinal Product Risk Communication: A New Special Interest Group of the International Society of Pharmacovigilance
Communicating with patients and healthcare providers aboutthe risks of harm with medicines and how to use medicinessafely is vital to pharmacovigilance for fulfilling its objectives.Drug Saf (2015) 38:621–627
Author: Bahri, Priya; Dodoo, Alexander N.; Edwards, Brian D.; Edwards, I. Ralph; et al
Date: 2015-06-02 -
Scientific publications
Varenicline and Abnormal Sleep Related Events
The study aimed to assess adverse drug reaction reports of “abnormal sleep related events” associated with varenicline, a partial agonist to the α4β2 subtype of nicotinic acetylcholine receptors on neurones, indicated for smoking cessation.Sleep (2015) 38 (5): 833-837.
Author: Ruth L. Savage, Alem Zekarias, Pia Caduff-Janosa
Date: 2015-05-01 -
Scientific publications
The Monitoring Medicines Project: A Multinational Pharmacovigilance and Public Health Project
Drug Saf. 2015;38(4):319-28.
Author: Shanthi N. Pal, Sten Olsson, Elliot G. Brown
Date: 2015-04-01 -
Scientific publications
Adverse Drug Reaction reports for cardiometabolic drugs from sub-Saharan Africa: a study in VigiBase.
Trop Med Int Health, 2015. 20(6): 797-806.
Author: Berhe, D.F., Juhlin K., Star K., Beyene K.G., Dheda M., Haaijer-Ruskamp F.M., Taxis K. and Mol P.G.
Date: 2015-03-18 -
Scientific publications
Targeted Spontaneous Reporting of Suspected Renal Toxicity in Patients Undergoing Highly Active Anti-Retroviral Therapy in Two Public Health Facilities in Uganda
Drug Saf. 2015;38(4):395-408.
Author: Helen Ndagije, Victoria Nambasa, Elizabeth Namagala, Huldah Nassali, Dan Kajungu, Gordon Sematiko, Sten Olsson, Shanthi Pal
Date: 2015-03-07 -
Scientific publications
User-driven development of a web-based tool for patient reporting of drug-related harm
Drug Saf. 2015;38(4):359-64.
Author: Monica Plöen, Magnus Wallberg, Sten Olsson
Date: 2015-02-25 -
Scientific publications
Using VigiBase to identify substandard medicines: Detection Capacity and key prerequisites
In 2011, UMC constructed a novel algorithm to identify reporting patterns suggestive of substandard medicines in spontaneous reporting, and applied it to VigiBase, the World Health Organization’s global individual case safety report database. Drug Safety. 2015;38(4):373-82.
Author: Kristina Juhlin, Ghazaleh Karimi, Maria Andér, Sara Camilli, Mukesh Dheda, Tan Siew Har, Rokiah Isahak, Su-Jung Lee, Sarah Vaughan, Pia Caduff, G. Niklas Norén
Date: 2015-02-17 -
Scientific publicationsLongitudinal medical records as a complement to routine drug safety signal analysis
To explore whether and how longitudinal medical records could be used as a source of reference in the early phases of signal detection and analysis of novel adverse drug reactions (ADRs) in a global pharmacovigilance database.Pharmacoepidemiology and Drug Safety 2015; 24: 486–494.
Author: Kristina Star, Sarah Watson, Lovisa Sandberg, Jeanette Johansson, I. Ralph Edwards
Date: 2015-01-27 -
Scientific publicationsHow safe is paracetamol?
Paracetamol is the most widely used medicine in children, in hospital and in the community. In most countries it is available over the counter and as a prescribed medicine.Arch Dis Child 2015;100:73–74.
Author: Kristina Star, Imti Choonara
Date: 2015-01-01 -
Scientific publicationsStructured Assessment for Prospective Identification of Safety Signals in Electronic Medical Records: Evaluation in the Health Improvement Network
Pharmacovigilance signal detection largely relies on individual case reports, but longitudinal health data are being explored as complementary information sources.Drug Saf (2015) 38:87–100.
Author: Cederholm, S., Hill, G., Asiimwe, A., Bate, A., Bhayat, F., Persson Brobert, G., Bergvall, T., Ansell, D., Star, K., Norén, G. N.
Date: 2014-12-25 -
Scientific publications
Assessment of a new instrument for detecting preventable adverse drug reactions
Drug Saf. 2015;38(4):383-93.
Author: Raja Benkirane, Rachida Soulaymani-Bencheikh, Asmae Khattabi, Ghita Benabdallah, Loubna Alj, Houda Sefiani, Khedidja Hedna, Lahcen Ouammi, Sten Olsson, Shanthi N. Pal
Date: 2014-12-24 -
Scientific publicationsPharmacovigilance for a Revolving World: Prospects of Patient-Generated Data on the Internet
The past 10 years have seen the advent of smartphones and a massive increase in the use and influence of the internet and social media in our daily lives.Drug Safety, October 2014, Volume 37, Issue 10, pp 761–764.
Author: Norén, G. Niklas
Date: 2014-10-01 -
Scientific publicationsValproic Acid and Fatalities in Children: A Review of Individual Case Safety Reports in VigiBase
Valproic acid is a widely used antiepileptic drug (AED) that is highly effective both in adults and children.PLoS ONE 9(10): e108970. doi:10.1371/journal.pone.0108970.
Author: Kristina Star, I. Ralph Edwards, Imti Choonara
Date: 2014-10-01