Results 71 to 80 of about 2,244 (146)

Cycle-Conditional and Titration-Phase Weibull Triangulation of Levothyroxine Adverse Events Across FAERS, DAEN, and EudraVigilance

Pre-registered analysis plan and reproducibility artefacts for a three-jurisdiction disproportionality plus time-to-onset analysis of levothyroxine adverse events in the US FDA FAERS, Australian TGA DAEN, and European EudraVigilance spontaneous-reporting
Hayden Farquhar
core   +6 more sources

Big data in veterinary medicines regulation: A data landscape analysis to support regulatory activities

Veterinary Record, Volume 198, Issue 11, Page e489-e502, 30 May/6 June 2026.
Abstract Background This study describes the development of a data landscape analysis protocol that identifies and characterises animal health data sources to support key regulatory activities throughout the life cycle of veterinary medicines. Methods The protocol included: development of criteria to identify data sources; selection of variables to ...
Ewa Pacholewicz, Eduardo de Freitas Costa, Mariana Avelino de Souza Santos, Bjorn Berendsen, Jos A. A. M. Verstegen   +4 more
wiley   +1 more source

Basophil activation test and lymphocyte transformation test in cefuroxime-induced anaphylactic reactions

Frontiers in Allergy
IntroductionCefuroxime allergy may present as a delayed-type reaction or as an immunoglobulin (Ig)E-mediated immediate-type anaphylactic reaction. The basophil activation test (BAT) is a diagnostic tool for cefuroxime-induced immediate-type reactions ...
Andreas Glässner, Diana Dubrall, Diana Dubrall, Gerda Wurpts, Gerda Wurpts, Philipp Deck, Günther Weindl, Caspar A. Heubach, Amir S. Yazdi, Amir S. Yazdi, Bernhardt Sachs, Bernhardt Sachs   +11 more
doaj   +1 more source

Incretin-based therapy and acute cholecystitis: a review of case reports and EudraVigilance spontaneous adverse drug reaction reporting database

, 2016
WHAT IS KNOWN AND OBJECTIVE: Glucagon-like peptide-1 (GLP-1) receptor agonists delay gastric and bowel emptying. A similar inhibitory effect of GLP-1 on gallbladder motility has been suggested, possibly leading to an increased risk of cholecystitis ...
RUSSO, GIUSEPPINA, GIANDALIA, ANNALISA, CUCINOTTA, Domenico Maria, TRIFIRO', Gianluca, Smits, M, Cutroneo D, Pizzimenti, V   +6 more
core   +1 more source

Hemorrhagic and thrombotic adverse events associated with emicizumab and extended half-life factor VIII replacement drugs: EudraVigilance data of 2021

, 2023
Background: Safety concerns for an increased risk of thrombotic complications in patients with hemophilia A have been pointed out, particularly during nonreplacement treatment with emicizumab and concomitant bypassing agents.
Ciavarella, Alessandro, Peyvandi, Flora, Noone, Declan, Abbattista, Maria   +3 more
core   +1 more source

EudraVigilance insights:Suspected adverse drug reactions in infants through breastfeeding

Aims: We aimed to describe suspected adverse drug reactions (ADRs) in infants resulting from medications transmitted through mothers' milk, as reported to the European ADR database, EudraVigilance.
Horwitz, Henrik, Gade, Christina, Stark, Anette Kirstine, Heerfordt, Ida M., Gotfredsen, Ditte Resendal, Lausten-Thomsen, Ulrik, Olsen, Rasmus Huan, Andersen, Jon Trærup   +7 more
core   +1 more source

Interstitial lung disease induced by fluoxetine: Systematic review of literature and analysis of Vigiaccess, Eudravigilance and a national pharmacovigilance database.

, 2017
We investigated a pulmonary adverse drug reaction possibly induced by fluoxetine, the Interstitial Lung Disease, by performing a systematic review of published case reports on this subject, a review of the World Health Organization VigiAccess database ...
PISANU, CLAUDIA, DEL ZOMPO, MARIA, Alberto Bocchetta, Maria Del Zompo, Stochino, Me, Arianna Deidda, Maria Erminia Stochino, BOCCHETTA, ALBERTO, DEIDDA, ARIANNA, Claudia Pisanu, Micheletto, L, Laura Micheletto   +11 more
core   +1 more source

Costs of Treating Onasemnogene Abeparvovec‐Xioi‐Induced Liver Injury

Pharmacology Research & Perspectives
Aims were to reveal types of onasemnogene abeparvovec‐xioi (OA)‐induced liver injury, their treatment patterns, utilization of healthcare, and treatment costs.
Andrej Belančić, Branislava Raičević, Ivana Stević, Dinko Vitezić, Slobodan M. Janković   +4 more
doaj   +1 more source

Adverse Reactions to the Orphan Drug Cerliponase Alfa in the Treatment of Neurolipofuscinosis Type 2 (CLN2)

Pharmaceuticals
Background/Objectives: Neuronal Ceroid Lipofuscinosis type 2 is a rare pathology affecting mainly the central nervous system (CNS) and retina, and is caused by variants in the gene encoding the lysosomal enzyme tripeptidyl peptidase 1.
Ilaria Ammendolia, Maria Sframeli, Emanuela Esposito, Luigi Cardia, Alberto Noto, Mariaconcetta Currò, Gioacchino Calapai, Maria De Pasquale, Carmen Mannucci, Fabrizio Calapai   +9 more
doaj   +1 more source

Adverse drug withdrawal event signals in FAERS and Eudravigilance databases: a stratified disproportionality analysis study

Background: Adverse drug withdrawal events (ADWEs) are a key safety concern during deprescribing but remain poorly explored in pharmacovigilance systems.
Frank Moriarty, Kieran Dalton, Caroline McCarthy, Emily Reeve, Zakir Khan, Katharina Tabea Jungo, Ann Sinead Doherty   +6 more
core   +1 more source