May 10, 2026
Safety recommendations for two medicinal products: the CAR-T cell therapy axicabtagene ciloleucel (Yescarta) and the tyrosine kinase inhibitor ponatinib (Iclusig).
Safety recommendations for two medicinal products: the CAR-T cell therapy axicabtagene ciloleucel (Yescarta) and the tyrosine kinase inhibitor ponatinib (Iclusig).
World Tuberculosis Day 2026 – "Yes! We Can End TB: Led by Countries, Powered by People" From a pharmacovigilance perspective, TB presents two distinct challenges: Drug-Induced TB: Immunosuppressive medications—particularly biologics used in autoimmune diseases—can reactivate latent TB infection or predispose to new active TB. Anti-TB Drug Adverse Reactions: First-line and second-line anti-TB drugs carry significant...
This comprehensive review examines the pharmacovigilance landscape of major GI drug classes, including proton pump inhibitors (PPIs), prokinetic agents (domperidone, metoclopramide), sphingosine-1-phosphate (S1P) receptor modulators, and small molecule drugs for inflammatory bowel disease (IBD).
From a pharmacovigilance standpoint, Ramadan represents a period of systematic medication schedule disruption, altered drug pharmacokinetics, and increased vulnerability to adverse drug reactions (ADRs).
At its January 2026 meeting, PRAC adopted important new safety information concerning three distinct medicinal products: cefazolin (and cefazolin with lidocaine), erdatinib, and pegylated liposomal doxorubicin.
Chronic Kidney Disease (CKD) significantly alters the pharmacokinetics and pharmacodynamics of many drugs, making medication management a critical aspect of patient care. In the context of dialysis access procedures—such as central venous catheter insertion or arteriovenous fistula placement—drug safety becomes even more paramount. This article synthesizes key recommendations and evidence-based practices from the...
This document is a supplementary publication from the European Medicines Agency (EMA). It provides the exact legal wording that must be inserted into the official product information for medicines, based on the safety recommendations made by the Pharmacovigilance Risk Assessment Committee (PRAC) during its October 2025 meeting.
Advancing Medication Safety Through Knowledge and Vigilance
