Results 41 to 50 of about 2,244 (146)

Resolving Issues About Efficacy and Safety of Low-Dose Codeine in Combination Analgesic Drugs: A Systematic Review

Pain and Therapy, 2020
Introduction The objective of this systematic review is to reflect on assumptions in relation to codeine use in combination with other analgesics. Methods MEDLINE was searched according to the predetermined keywords and criteria.
Ivan Ćelić, Lidija Bach-Rojecky, Iveta Merćep, Ana Soldo, Anja Kos Petrak, Ana Bučan   +5 more
doaj   +1 more source

An exploratory study of the impact of COVID-19 vaccine spontaneous reporting on masking signal detection in EudraVigilance

, 2023
Introduction: During the signal detection process, statistical methods are used to identify drug-event combinations (DECs) which are disproportionately reported when compared with other drugs and events in the entire database.
Micallef, Benjamin, Sultana, Janet, Borg, John-Joseph, Nistico', Robert Giovanni, Nisticò, Robert, Borg, John Joseph, Straus, Sabine M J M, Serracino-Inglott, Anthony, Dogné, Jean-Michel, Straus, Sabine M.J.M.   +9 more
core   +1 more source

COVID-19 Vaccines and Heavy Menstrual Bleeding:The Impact of Media Attention on Reporting to EudraVigilance [PDF]

Background and Objective: During the COVID-19 vaccination campaign, over 34,000 reports of heavy menstrual bleeding following the administration of COVID-19 vaccines originating in the Economic European Area were submitted to EudraVigilance, the European
Yalmanová, Vladimíra, Szmigiel, Agnieszka, Genov, Georgy, Straus, Sabine, Gordillo-Marañón, María, Caplanusi, Irina, Olsen, David Benee   +6 more
core   +1 more source

Spontaneous reports of adverse reactions to methotrexate: retrospective analysis in the Russian Federation

Фармакоэкономика
Background. Methotrexate (MTX) is a widely prescribed medication known for its pronounced anti-inflammatory and anti-tumor effects. However, its use is associated with risks of adverse drug reactions (ADRs) including gastrointestinal tract, infectious ...
S. A. Stefanova, Ya. D. Belousova, V. V. Rafalskiy   +2 more
doaj   +1 more source

Cell and Gene Therapies Manufacturing Challenges and Integrated Good Manufacturing Practices Solutions: A Lifecycle Perspective

Biotechnology and Bioengineering, EarlyView.
Lifecycle perspective on cell and gene therapy manufacturing challenges and enabling GMP solutions. ABSTRACT Cell and gene therapies (CGTs) are revolutionizing modern medicine; however, making these advanced medicines scalable and readily available to commercial manufacturers worldwide is a major challenge. The number of approved CGT products continues
Rajath Samaga, Udisha Singh, Sachin Dattram Pawar   +2 more
wiley   +1 more source

Immune checkpoint inhibitor‐induced arrhythmias: Mechanistic insights from clinical and preclinical studies

British Journal of Pharmacology, EarlyView.
Immune checkpoint inhibitors (ICIs) have transformed cancer therapy, but their efficacy continues to be limited by immune‐related adverse events. Among these, ICI‐induced cardiac arrhythmias are increasingly recognised as a major adverse reaction, encompassing a broad spectrum of clinical phenotypes, including conduction blocks, atrial fibrillation and
Anand R. Ramalingam, Zoltán Márton Köhler, Péter Ferdinandy, Zoltán V. Varga   +3 more
wiley   +1 more source

Risk of hepatitis B virus reactivation following treatment with abatacept: A retrospective study of international pharmacovigilance databases

EClinicalMedicine, 2022
Summary: Background: Abatacept is a selective T-cell costimulation modulator approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, and psoriatic arthritis.
Jingjing Wang, Xin Zhang, Xiaozhen Geng, Juanjuan Shi, Xiaoli Jia, Shuangsuo Dang, Wenjun Wang   +6 more
doaj   +1 more source

Codeine toxicity via breast Milk: Can this occur and implications for opiate therapy in children

British Journal of Clinical Pharmacology, Volume 92, Issue 9, Page 3012-3016, September 2026.
Codeine is commonly used in combination analgesic products. The use of codeine during breastfeeding can rarely be associated with serious adverse effects related to genetic polymorphisms affecting codeine's metabolism and disposition. Clinicians treating infants of breastfeeding mothers should be aware of this rare but potentially serious complication.
Michael Rieder
wiley   +1 more source

EudraVigilance Medicines Safety Database:Publicly Accessible Data for Research and Public Health Protection

, 2018
The analysis of safety data from spontaneous reporting systems has a proven value for the detection and analysis of the risks of medicines following their placement on the market and use in medical practice.
Anja van Haren, Gianmario Candore, Slattery, Jim, Domergue, Francois, Peter Arlett, Candore, Gianmario, Arlett, Peter, Jim Slattery, Dogné, Jean-Michel, Francois Domergue, van Haren, Anja, Xavier Kurz, Jean-Michel Dogné, Postigo, Rodrigo, Rodrigo Postigo, Brosch, Sabine, Kurz, Xavier, Sabine Brosch   +17 more
core   +1 more source

Neurological Adverse Events Associated With Immune Checkpoint Inhibitors Identified Through Disproportionality Analysis of the FDA Adverse Event Reporting System

Cancer Medicine, Volume 15, Issue 9, September 2026.
ABSTRACT Background Neurological immune‐related adverse events (N‐irAEs) from immune checkpoint inhibitors (ICIs) are rare but potentially fatal. This study aimed to characterize their real‐world profile to support early detection and management.
Tao Chen, Kexin Shu, Hongyi Xiao, Yonghua Yuan, Fujun Zhang, Yu Liu   +5 more
wiley   +1 more source