Drug Safety Newsletter – Edition 117 – 29 November 2024
29/11/2024
Medicines for human use
Safety update
The latest edition of the HPRA newsletter includes important updates to support the safe and appropriate use of the following medicines:
- Fluconazole: Update on pregnancy outcomes following use and new advice for women of childbearing potential
- Finasteride and dutasteride: Commencement of EU review regarding association with suicidal ideation and behaviours
- Omega-3-acid ethyl ester medicines: Dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular diseases or risk factors
- Product information updates recommended by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC)