The newsletter is structured into three main sections, each containing crucial safety information:
1. Regulatory Matters
This section details specific regulatory actions taken by authorities worldwide concerning various medicinal products.
- Darvadstrocel: Withdrawn from the EU market due to a lack of demonstrated benefit.
- Glatiramer Acetate (for MS): US FDA added a Boxed Warning for the risk of anaphylaxis, which can be fatal.
- GLP-1 Receptor Agonists (e.g., for diabetes/obesity): UK MHRA warned about the risk of pulmonary aspiration during anesthesia due to delayed gastric emptying.
- Statins (HMG-CoA reductase inhibitors): Health Canada confirmed a possible link to myasthenia gravis as a class effect.
- RSV Vaccines (Abrysvo, Arexvy): US FDA required new warnings about a suggested increased risk of Guillain-Barré syndrome (GBS).
- Topiramate: South African authorities highlighted the risk of neurodevelopmental disorders in children exposed in utero.
2. Safety of Medicinal Products
This section provides important safety reminders and new information on specific drugs.
- Fezolinetant (for menopause): EMA reminded healthcare professionals of the risk of drug-induced liver injury, necessitating liver function tests before and during treatment.
- Semaglutide (e.g., Ozempic, Wegovy): EMA’s safety committee (PRAC) started a review to assess a potential link to a rare eye condition, non-arteritic anterior ischemic optic neuropathy (NAION).
- Systemic Fluoropyrimidines (cancer drugs): Health Canada recommended testing for DPD deficiency before treatment due to the risk of severe, potentially fatal toxicity.
- Thiocolchicoside (muscle relaxant): The Egyptian Pharmacovigilance Center (EPVC) issued a reminder about the risk of genotoxicity and updated contraindications for systemic use.
3. Feature: Key Recommendations from WHO Expert Committees
This section summarizes critical advice from the joint meeting of the WHO Advisory Committee on Safety of Medicinal Products (ACSOMP) and the Global Advisory Committee on Vaccine Safety (GACVS) in November 2024.
- Arpraziquantel (for schistosomiasis in children): Emphasized the need for robust safety monitoring in pediatric populations, especially children under one, using existing national systems.
- Nirsevimab (RSV monoclonal antibody): Recommended continued monitoring for adverse events, especially with co-administration of other vaccines.
- Valproate: Strongly supported global efforts to minimize the use of this known teratogen in women and girls of childbearing potential.
- Tecovirimat (for mpox): Highlighted the need for more data on use in special populations and the importance of taking it with a fat-containing meal for proper absorption.
- Fexinidazole (for sleeping sickness): Stressed the importance of tailored pharmacovigilance and training for healthcare workers on managing psychiatric adverse effects like depression and suicidal ideation.
