Results 1 to 10 of about 2,244 (146)

Vigi4Eudra-score: Evaluation of the completeness of spontaneous adverse drug reaction reports in EudraVigilance. [PDF]

PLoS ONE
IntroductionThe vigiGrade completeness score established in VigiBase, the worldwide ADR database, measures the completeness of information provided in the structured format of each ADR report. Currently, no such measurement is implemented in the European
Patrick Christ, Diana Dubrall, Dennis Lex, Thomas Grüger, Matthias Schmid, Bernhardt Sachs   +5 more
doaj   +3 more sources

Adverse Reactions to Evolocumab: Analysis of Real-World Data from EudraVigilance

Pharmaceuticals
Background: Evolocumab is a humanized immunoglobulin G2 monoclonal antibody, directed against Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9), prescribed in hypercholesterolemic patients.
Gioacchino Calapai, Emanuela Esposito, Luigi Cardia   +2 more
exaly   +4 more sources

Vitamin K Antagonists (VKAs) and Novel Oral Anticoagulants (NOACs) Safety Comparison Based on Data from EudraVigilance Database [PDF]

Hematology Reports
Background: Clinical trials comparing novel oral anticoagulants (NOACs) with warfarin reported a lower mortality rate and a reduced incidence of bleeding with NOACs. However, these studies do not allow for final conclusions about safety. Moreover, direct
Pier Paolo Olimpieri, Fanny Erika Palumbo, Gaetano Giuffrida, Edoardo Milanetti, Cecilia Gozzo, Elisa Lucia Scebba, Giovanni Luca Romano, Giovanni Enrico Lombardo, Andrea Duminuco, Calogero Vetro, Davide Giuseppe Castiglione, Giuseppe Alberto Palumbo, Salvatore Scarso, Filippo Drago, Lucia Gozzo   +14 more
doaj   +3 more sources

Association Between DPPs-4 Inhibitors and Bullous Pemphigoid: Reporting Odds Ratio Analysis Using EudraVigilance Database [PDF]

Pharmaceuticals
Background/Objectives: Bullous pemphigoid (BP) is an autoimmune blistering skin disease. The association between dipeptidyl peptidase 4 inhibitors (DPP-4 inhibitors) and bullous pemphigoid (BP) has been studied in many countries; however, controversy has
Ana Aldea-Perona
exaly   +4 more sources

Preliminary evidence on the safety profile of BNT162b2 ( Comirnaty ): new insights from data analysis in EudraVigilance and adverse reaction reports from an Italian health facility

Human Vaccines and Immunotherapeutics, 2021
The first vaccine against SARS-CoV-2 made available in Italy has been BNT162b2, the two-dose mRNA-based vaccine developed by Pfizer-BioNTech. The ASST Fatebenefratelli-Sacco hospital is located in one of the areas most affected by the pandemic, and to ...
Emilio Clementi, Carla Carnovale, Sonia Radice   +2 more
exaly   +2 more sources

A ‘One Health’ cross-sectional analysis of reports of potential antibiotic resistance cases in international pharmacovigilance databases [PDF]

Frontiers in Public Health
IntroductionAntibiotic resistance is a global health problem that requires ‘One Health’ interventions encompassing human, animal, and environmental health.
Joseph Mitchell, Joseph Mitchell, Pinelopi Lundquist, Camilla Westerberg, Manju Purohit, Manju Purohit, Cecilia Stålsby Lundborg   +6 more
doaj   +2 more sources

Reporting patterns of suicide- and self-injury-related events involving liraglutide, semaglutide, and tirzepatide: data from the European pharmacovigilance database [PDF]

Frontiers in Pharmacology
IntroductionGlucagon-like peptide-1 (GLP-1) and GIP receptor agonists (RAs) are increasingly used for treating type 2 diabetes mellitus and for chronic weight management.
Cristina Scavone, Cristina Scavone, Cristina Scavone, Michele Cerasuolo, Mario Gaio, Mario Gaio, Mario Gaio, Nicoletta Lettera, Nicoletta Lettera, Francesca Futura Bernardi, Annalisa Capuano, Annalisa Capuano, Barbara Rinaldi   +12 more
doaj   +2 more sources

Unmasking counterfeit semaglutide: analysis of real-world safety data from EudraVigilance [PDF]

Frontiers in Pharmacology
IntroductionThe spread of counterfeit drugs represents a serious threat to public health because they may be ineffective or cause the onset of severe suspected adverse drug reactions (ADRs). To date, the traceability of semaglutide-based products, widely
Alessia Zinzi, Alessia Zinzi, Alessia Zinzi, Mario Gaio, Mario Gaio, Mario Gaio, Rosanna Ruggiero, Rosanna Ruggiero, Rosanna Ruggiero, Annamaria Mascolo, Maria Antonietta Riemma, Mattia Cipriani, Mattia Cipriani, Ludovica Vittoria Laino, Ludovica Vittoria Laino, Liberato Berrino, Francesco Rossi, Francesco Rossi, Annalisa Capuano, Annalisa Capuano   +19 more
doaj   +2 more sources

Safety of Drugs Used in Difficult-to-Treat Epileptic Syndromes: A Disproportionality Analysis Using the Eudravigilance Database [PDF]

Pharmaceuticals
Background/Objectives: Difficult-to-treat epileptic syndromes include conditions typically emerging in the first years of life and are characterized by a high rate of drug refractoriness. This study aimed to better define the safety profile of drugs used
Arianna Scala, Teresa Angela Trunfio, Chiara Pennisi, Giovanni Enrico Lombardo, Vincenzo Micale, Serena Di Martino, Giorgia Fiorenza, Adriana Carol Eleonora Graziano, Marilena Briglia, Fabio Allia, Giovanni Giurdanella, Roberta Malaguarnera, Rosalia Battaglia, Cecilia Gozzo, Fanny Erika Palumbo, Calogero Vetro, Giovanni Improta, Mario Damiano Toro, Filippo Drago, Giovanni Luca Romano, Lucia Gozzo   +20 more
doaj   +2 more sources

Adverse Respiratory Reactions to Tyrosine Kinase Inhibitors: A Disproportionality Analysis of Spontaneous Reports from European Countries [PDF]

Life
Background: The tyrosine kinase inhibitors (TKIs) asciminib, bosutinib, dasatinib, imatinib, nilotinib, and ponatinib have been approved for chronic myelogenous leukemia (CML) therapy.
Ilaria Ammendolia, Carmen Mannucci, Emanuela Esposito, Gioacchino Calapai, Mariaconcetta Currò, Paola Midiri, Cristina Mondello, Antonino Cancellieri, Luigi Cardia, Fabrizio Calapai   +9 more
doaj   +2 more sources