Product information updates for desogestrel/etonogestrel and meningioma, levonorgestrel intrauterine systems and ectopic pregnancy, and information concerning atogepant and insomnia, CGRP antagonists and Raynaud's phenomenon, oseltamivir safety in critically ill patients, sacituzumab govitecan and interstitial lung disease, selpercatinib and intestinal lymphangiectasia, and sevoflurane and acute encephalopathy in patients carrying the mitochondrial DNA variant m.11232T>C.
Insulin Syringe Safety, Drug-Drug Interactions with Valproic Acid and Methotrexate, and Denosumab-Induced Mineral Metabolism Disturbances
Pancreatin and HEV Transmission, Amoxicillin-Associated Encephalopathy, SGLT2 Inhibitors and Lichen Sclerosus, GLP-1 RA Peripheral Neuropathies and Volvulus, and More
The year 2025 witnessed significant regulatory actions affecting the safety profiles of multiple gastrointestinal drug classes. From the persistent concerns surrounding PPIs and the emerging risks of GLP-1 receptor agonists, to the serious gastrointestinal toxicities of CAR-T therapy and the cardiac risks of loperamide overuse, the regulatory landscape for GI drugs continues to...
Drug Safety Update on Nasal Decongestants and a Local Case Report on Colistimethate-Induced Neurotoxicity
Regulatory update on isotretinoin prescribing requirements, a detailed local case safety report documenting posterior reversible encephalopathy syndrome (PRES) in two pediatric oncology patients receiving cyclophosphamide-containing chemotherapy.
New aspect of a known risk (aseptic meningitis in healthy young adults following live attenuated chikungunya vaccination), a new adverse reaction for an established acetylcholinesterase inhibitor (nightmares with galantamine), and a request for supplementary information on the increased risk of ectopic pregnancy with lower-dose levonorgestrel intrauterine devices (13.5 mg).
Advancing Medication Safety Through Knowledge and Vigilance
