September 29, 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.
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
Afatinib, Lenvatinib, Lenvima, Kisplyx
Advancing Medication Safety Through Knowledge and Vigilance
