Results 11 to 20 of about 3,513 (158)

Analysis of Hepatobiliary Disorder Reports Associated With the Use of Herbal Medicines in the Global Suspected ADR Database Vigibase

Frontiers in Pharmacology, 2019
Introduction: Use of herbal medicines (HMs) is widespread across the world, with many people relying on HMs for their primary healthcare or using HMs in the context of a healthy life style.
Andrea Kuemmerle, Lida Teng, Jia-Bo Wang   +2 more
exaly   +4 more sources

Pharmacological Evaluation of Signals of Disproportionality Reporting Related to Adverse Reactions to Antiepileptic Cannabidiol in VigiBase [PDF]

Pharmaceuticals, 2023
Cannabidiol is the first cannabis-derived drug approved for the treatment of Lennox–Gastaut syndrome, Dravet syndrome, and Tuberous Sclerosis Complex. In the current study, we performed a descriptive analysis followed by a disproportionality analysis of ...
Fabrizio Calapai, Carmen Mannucci, Liana McQuain, Francesco Salvo   +3 more
doaj   +2 more sources

Disproportionality and Case-Based Evidence for a Possible Association Between Fluoroquinolones and Kounis Syndrome [PDF]

Pharmaceuticals
Background/Objectives: Drug-induced hypersensitivity and cardiotoxicity are important yet often underrecognized clinical concerns, and fluoroquinolones are widely used antibiotics with well-documented safety issues.
Milena Cmiljanić, Miloš Milosavljević, Filip Jovčić, Mladen Pavlović, Srdjan Stefanović   +4 more
doaj   +2 more sources

Pharmacovigilance in Action: Utilizing VigiBase Data to Improve Clozapine Safety [PDF]

Patient Preference and Adherence
Carlos De las Cuevas,1 Emilio J Sanz,2,3 Jose de Leon4,5 1Department of Internal Medicine, Dermatology, and Psychiatry and Instituto Universitario de Neurociencia (IUNE), Universidad de La Laguna, La Laguna, Canary Islands, Spain; 2Department of Physical
De las Cuevas C, Sanz EJ, de Leon J
doaj   +1 more source

Real-World Sodium Fluoride Safety Signals: Dual-Database Pharmacovigilance [PDF]

International Dental Journal
Introduction and aims: Sodium fluoride is widely used in preventive dentistry, yet its global safety profile has not been comprehensively characterised using real-world data.
Wanchen Ning, Xiangyu Huang, Simin Li, Linxin Jiang, Daniel R Reissmann, Deborah Kreher, Gerhard Schmalz, Lei Chen, Shaohong Huang   +8 more
doaj   +2 more sources

The real-world safety evaluation of the selective NaV1.8 inhibitor suzetrigine: disproportionality analysis and flexible empirical bayes signals from FAERS with external triangulation [PDF]

Frontiers in Pharmacology
BackgroundSuzetrigine (Journavx; VX-548), the first selective NaV1.8 voltage-gated sodium channel inhibitor approved by the FDA on 30 January 2025, represents a novel non-opioid option for moderate-to-severe acute pain.
Kun Lai, Kun Lai, Lan Luo, Fuzhao Zhang, Eugenie Sin Sing Tan, Anand Gaurav, Jianghua Zheng, Jianghua Zheng, Chung Keat Tan   +8 more
doaj   +2 more sources

Global insights into [177Lu]Lu-DOTATATE safety: a comprehensive disproportionality analysis from the WHO pharmacovigilance database [PDF]

Scientific Reports
Peptide receptor radionuclide therapy with [177Lu]Lu-DOTATATE is an effective treatment for metastatic or inoperable neuroendocrine tumors. While clinical trials have demonstrated its efficacy and safety in a limited number of selected patients, real ...
Typhanie Ladrière, Basile Chrétien, Anne-Laure Bignon, Karine Bouhier-Leporrier, Charles Dolladille, Jonathan Vigne   +5 more
doaj   +2 more sources

Calcitonin gene-related peptide antagonists in pregnancy: a disproportionality analysis in VigiBase® [PDF]

The Journal of Headache and Pain
Background Current evidence on the safety of calcitonin gene–related peptide antagonists (CGRP-A) in pregnancy for the treatment of both episodic and chronic migraine is scarce and does not yet provide definitive information.
Roberta Noseda, Francesca Bedussi, Claudio Gobbi, Alessandro Ceschi, Chiara Zecca   +4 more
doaj   +2 more sources

Revealing the reporting disparity: VigiBase highlights underreporting of clozapine in other Western European countries compared to the UK. [PDF]

, 2023
BACKGROUND: Pharmacovigilance studies indicate clozapine history is marked by adverse drug reactions (ADRs). OBJECTIVE: In a 2021 article, the United Kingdom (UK) had >90 % of European clozapine-related fatal outcomes in VigiBase, the World Health ...
Verdoux, Hélène; https://orcid.org/, Correll, Christoph U; https://orcid.org/, Schulte, Peter F J; https://orcid.org/, Schoretsanitis, Georgios; https://orcid.org/, Sanz, Emilio J; https://orcid.org/, Bostrom, Adrian D; https://orcid.org/, Fernandez-Egea, Emilio; https://orcid.org/, de Filippis, Renato; https://orcid.org/, Gross, Jason A; https://orcid.org/, De las Cuevas, Carlos; https://orcid.org/, de Leon, Jose; https://orcid.org/, Lally, John; https://orcid.org/, Arrojo-Romero, Manuel; https://orcid.org/, Molden, Espen; https://orcid.org/   +13 more
core   +4 more sources

Risk Factors for Respiratory Depression Associated with Tramadol Based on the Global Pharmacovigilance Database (VigiBase)

Pharmaceuticals
Tramadol, a weak μ-opioid receptor agonist, has been used worldwide for pain management. It is considered to have a favorable safety profile without serious adverse events; however, safety issues of respiratory depression were proposed by regulatory ...
Sunny Park, Geon-Ho Lee, Soyun Kim, Solee Kim, Yeju Kim, Soo-An Choi   +5 more
doaj   +2 more sources