Real-world safety of icosapent ethyl: analysis based on spontaneous reports in FAERS database

H Cai, B Jia, Z Fu, B Chen, Y Liu… - Expert Opinion on Drug …, 2024 - Taylor & Francis
Background The triglyceride-lowering drug, icosapent ethyl (IPE), was granted a new
indication for the reduction of atherosclerotic cardiovascular disease risk in 2019. This study …

[HTML][HTML] Response to “Evaluating Adverse Events in Databases”

F Calapai, C Mannucci, L Cardia, M Currò… - Pharmacology …, 2023 - ncbi.nlm.nih.gov
Katie Lovell and Steven R. Feldman commented and criticized our recent manuscript
entitled “Suspected oncologic adverse reactions associated with IL-23 inhibitors in …

An innovative method to strengthen evidence for potential drug safety signals using Electronic Health Records

H Abedian Kalkhoran, J Zwaveling… - Journal of Medical …, 2024 - Springer
Reports from spontaneous reporting systems (SRS) are hypothesis generating. Additional
evidence such as more reports is required to determine whether the generated drug-event …

Predicting Drugs Suspected of Causing Adverse Drug Reactions Using Graph Features and Attention Mechanisms

J Yang, Z Hu, L Zhang, B Peng - Pharmaceuticals, 2024 - mdpi.com
Background: Adverse drug reactions (ADRs) refer to an unintended harmful reaction that
occurs after the administration of a medication for therapeutic purposes, which is unrelated …

Appeal for Increasing the Impact of Pharmacovigilance

AC Kant - Drug Safety, 2024 - Springer
Pharmacovigilance (PV) is defined as the science and activities related to detecting,
assessing, understanding and preventing adverse effects and other medicine-related …

An open‐source implementation of tree‐based scan statistics

M Russo, SV Wang - Pharmacoepidemiology and Drug Safety, 2024 - Wiley Online Library
Purpose We develop an open‐source R package to implement tree‐based scan statistics
(TBSS) analyses. Methods TBSS are data mining methods used by the United States Food …

Optimal p-values and sample size for signal detection methods based on generalised Weibull distributions

O Sauzet, J Dyck, V Cornelius - arXiv preprint arXiv:2310.20573, 2023 - arxiv.org
Objectives: Statistical methods for signal detection of adverse drug reactions in electronics
health records (EHRs) are not usually provided with information about optimal p-values and …

Identification d'expositions médicamenteuses in utero associées à la survenue d'infections au cours de la première année de vie

M Tisseyre - 2023 - theses.hal.science
Les infections infantiles constituent une problématique majeure en termes de morbi-
mortalité à l'échelle mondiale, contribuant significativement aux décès infantiles, notamment …