Post-marketing safety surveillance of erenumab:new insight from Eudravigilance
, 2022 BACKGROUND: We aimed at evaluating adverse drug reactions during the post-marketing phase with erenumab as the suspected/interacting drug in Eudravigilance, with the final goal of investigating the consistency of the disproportionality signals (DS) for ...
Sessa, Maurizio, Liang, David
core +1 more source
Thrombotic adverse events reported for Moderna, Pfizer and Oxford-AstraZeneca COVID-19 vaccines: comparison of occurrence and clinical outcomes in the EudraVigilance database [PDF]
, 2021 Thrombotic adverse events reported for Moderna, Pfizer and Oxford-AstraZeneca COVID-19 vaccines: comparison of occurrence and clinical outcomes in the EudraVigilance ...
Katie MacLure +7 more
core +1 more source
Tramadol-induced hiccups: a case–noncase study in the European pharmacovigilance database
Therapeutic Advances in Drug Safety, 2021 Background: Hiccups are usually benign and self-limiting, but can sometimes be persistent. If left untreated, they can provoke severe discomfort, and even death. Hiccups can be idiopathic, organic, psychogenic, and caused by drugs.
Montserrat García +2 more
doaj +1 more source
Unresolved gustatory, olfactory and auditory adverse drug reactions to antibiotic drugs: a survey of spontaneous reporting to Eudravigilance [PDF]
, 2019 Objectives: Sensory adverse drug reactions (ADRs) are generally expected to be transient in nature. However, spontaneous reports describe frequently these events as long-lasting or unresolved.
Corrado Blandizzi (285059) +4 more
core +2 more sources
Pharmaceuticals, 2021 Remdesivir was recommended for hospitalized patients with COVID-19. As already reported in the Summary of Product Characteristics, most of remdesivir’s safety concerns are hepatoxicity and nephrotoxicity related.
Concetta Rafaniello +9 more
doaj +1 more source
Post-marketing safety of CGRP monoclonal antibodies and gepants: A systematic review of spontaneous reporting system data. [PDF]
HeadacheAbstract Objective Calcitonin gene‐related peptide (CGRP) inhibitors, including monoclonal antibodies (mAbs) and small‐molecule antagonists (gepants), have transformed migraine treatment. Although clinical trials established their efficacy and initial safety, post‐marketing surveillance is essential for understanding their real‐world safety profile in ...
Giacon M, Terrazzino S.
europepmc +2 more sources
Anaphylactic Reactions to COVID-19 Vaccines: An Updated Assessment Based on Pharmacovigilance Data
Vaccines, 2023 This study aimed at producing an updated assessment of the incidence of anaphylaxis associated with COVID-19 vaccines based on pharmacovigilance data. Anaphylactic reaction and anaphylactic shock data post-COVID-19-vaccination reported from week 52, 2020
Fotini Boufidou +7 more
doaj +1 more source
Immune Checkpoint Inhibitors and Cardiotoxicity: An Analysis of Spontaneous Reports in Eudravigilance [PDF]
, 2021 Introduction: Immune checkpoint inhibitors (ICIs) are widely used in the treatment of many cancers as they improve clinical outcomes. However, ICIs have also been associated with the development of immune-related adverse drug reactions (ADRs).
Ferrajolo C. +10 more
core +1 more source
Tapentadol: review of adverse drug reactions reported to Eudravigilance. [PDF]
, 2021 Background: Adverse drug reactions (ADRs) are a public health problem. Tapentadol is a novel opioid analgesic with a dual mode of action that was approved for acute and chronic pain. This drug has been associated with several ADRs, particularly involving
Cabral, Jorge +5 more
core +1 more source
Computerized systems and databases for pharmacovigilance in Russia
Реальная клиническая практика: данные и доказательстваThe results of identifying new risks for pharmacovigilance systems and databases in Russia, including the Roszdravnadzor's web-based pharmacovigilance system, are presented.
B. K. Romanov +4 more
doaj +1 more source