This document is a European Medicines Agency (EMA) publication, specifically from the Pharmacovigilance Risk Assessment Committee (PRAC). It details new safety information for several medicines, based on recommendations adopted in September 2025.
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
Mogamulizumab, Colitis
Advancing Medication Safety Through Knowledge and Vigilance
