An Individual Case Safety Report (ICSR) is the fundamental building block of pharmacovigilance. It is a structured document that captures detailed information about a suspected adverse event (or any other drug-related problem) in a single patient that is potentially associated with a medicinal product. In simple terms, it is the official “incident report” for a possible side effect or safety concern...
Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. In simpler terms, it is the ongoing process of: Monitoring the safety of medicines (and other health products) throughout their entire life cycle, from clinical trials to widespread public use. Identifying new or changing...
This document communicates important safety updates for three different categories of products, focusing on new aspects of known risks. Extracts from PRAC – July 2025.
Ciltabtagene autoleucel (Carvykti), Immune-mediated enterocolitis. Brodalumab, Pyoderma gangrenosum. Enzalutamide & Digoxin, Laboratory test interference leading to falsely elevated digoxin levels. Vortioxetine, Hallucinations, not related to serotonin syndrome
Seyraline, multiple acyl-coenzyme A dehydrogenase deficiency(MADD), Sulfamethoxazole, Trimethoprim (Cotrimoxazole), Circulatory shock
Oxytetracycline HCl, Hydrocortisone Acetate, Polymyxin B Sulfate (Ear/Eye Drops/Ointment), Hearing and vestibular disorders, Regorafenib, Stivarga, Hyperammonaemia, hyperammonaemic encephalopathy
Teysuno (tegafur, gimeracil,and oteracil), Hyperammonaemia
Advancing Medication Safety Through Knowledge and Vigilance
