Li, Huqun Wang, Chongshu Guo, Cuilian
Published in
Frontiers in Pharmacology
Background Lorlatinib displays marked systemic and intracranial efficacy against anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC). We aimed to establish the safety profile of lorlatinib based on the Food and Drug Administration Adverse Event Reporting System (FAERS). Methods Reports from the FAERS between 2019 and 2023 w...
Zhao, Dan Zhang, Wangxin Liu, Yan Yan, Zhaojun
Published in
Frontiers in Pharmacology
Objective Lumateperone, a novel antipsychotic drug that was granted by the Food and Drug Administration (FDA) approval in December 2019, remains insufficiently explored for its adverse event profile. This study used the FDA Adverse Event Reporting System (FAERS) database to explore its potential safety issues. Methods This study conducted a retrosp...
Cutroneo, Paola Maria Sartori, Daniele Tuccori, Marco Crisafulli, Salvatore Battini, Vera Carnovale, Carla Rafaniello, Concetta Capuano, Annalisa Poluzzi, Elisabetta Moretti, Ugo
...
Published in
Frontiers in Drug Safety and Regulation
Spontaneous reporting systems remain pivotal for post-marketing surveillance and disproportionality analysis (DA) represents a recognized approach for early signal detection. Although DAs cannot be used per se as a standalone approach to assess a drug-related risk and cannot replace clinical judgment in the individual patient, their role remain irr...
Mancilla-Martinez, Jeannette Oh, Min Hyun Luk, Gigi Rollins, Adam
Published in
Journal of learning disabilities
Using U.S. state-level data, we report unadjusted and adjusted odds ratio of special education (SPED) trends in Tennessee from 2009 to 2019 for students in Grades 3 to 8 by three language groups: native English speakers (NES), English-proficient bilinguals (EPB), and Current English learners (Current EL). We report trends across all SPED disability...
Li, Huqun Wang, Chongshu Deng, Aiping Guo, Cuilian
Published in
Frontiers in Pharmacology
Background: Mepolizumab has been approved by the FDA for add-on maintenance treatment of severe asthma with an eosinophilic phenotype. Real-world studies on mepolizumab-associated adverse events are limited. The present study aimed to explore mepolizumab-related adverse events based on the US Food and Drug Administration Adverse Event Reporting Sys...
Shu, Yamin Chen, Jing Ding, Yiling Zhang, Qilin
Published in
Frontiers in Immunology
Background Risankizumab, a humanized IgG1 monoclonal antibody that selectively inhibits IL-23, is currently approved for the treatment of moderate-to-severe plaque psoriasis and Crohn’s disease. The real-world safety study of risankizumab in a large- sample population is currently lacking. The aim of this study was to evaluate risankizumab-associat...
Zhao, Yunfei Wang, Huiling Zhang, Qingsong Hu, Yongxin Xu, Yulong Liu, Wei
Published in
Expert opinion on drug safety
We study the adverse events (AEs) of bamlanivimab (BAM), bamlanivimab/etesevimab (BAM/ETE) to alert risk factors during coronavirus disease 2019 (COVID-19) treatment and provide references for drug safety. Extract AEs from the COVID-19 Emergency Use Authorization (EUA) FDA Adverse Event Reporting System (FAERS) Public Dashboard. Disproportionality ...
Ko, Minoh Oh, Jung Mi Kim, In-Wha
Published in
Frontiers in Medicine
Introduction Inverse signals produced from disproportional analyses using spontaneous drug adverse event reports can be used for drug repositioning purposes. The purpose of this study is to predict drug candidates using a computational method that integrates reported drug adverse event data, disease-specific gene expression profiles, and drug-induc...
Dolez, Bernard Laurent, Annie
Résumé Pour la première fois depuis l’adoption du quinquennat et l’inversion du calendrier électoral, les élections législatives de 2022 n’ont pas offert au président de la République élu une majorité stable pour gouverner. Le premier tour a vu l’apathie électorale gagner les électeurs d’Emmanuel Macron et, contrairement à 2017, les candidats d’Ens...
Woods, Richard H
Published in
Pharmacotherapy
Although rarely observed in clinical trials, alopecia has been reported in migraine patients treated with calcitonin gene-related peptide (CGRP) inhibitors during the postmarketing period. This study sought to assess whether CGRP inhibitors are associated with disproportionate alopecia reporting relative to other drugs including those indicated for...
