Published: 4 September 2025
Publications
MARC’s remarks: June 2025 meeting
Published: 4 September 2025
Prescriber Update 46(3): 40
September 2025
The Medicines Adverse Reaction Committee (MARC) convened for their 202nd meeting on 12 June 2025.
The Committee reviewed the safety of macrolide antibiotics (azithromycin, erythromycin, clarithromycin, roxithromycin) in regard to cardiovascular death. The Committee noted the warning in the clarithromycin data sheet about the risk of adverse cardiovascular outcomes. To ensure consistency across the medicine class, the Committee recommended updates to the macrolide data sheets to include this warning.
The Committee discussed the risk of Guillain-Barré Syndrome (GBS) following vaccination with Arexvy, a respiratory syncytial virus (RSV) vaccine. They noted that the risk of GBS was higher following RSV infection compared to vaccination. The Committee considered that the information on GBS in the Australian product information was balanced and reflected the available evidence. This includes that there is insufficient evidence to establish a causal relationship between GBS and Arexvy. The Committee recommended updates to the New Zealand data sheet to align with the Australian product information.
The Committee reviewed the risk of renal adverse events with nintedanib. They agreed that there was sufficient evidence for an association and recommended updates to the nintedanib data sheet to include proteinuria, renal failure and thrombotic microangiopathy as undesirable effects.
See the Medsafe website for the MARC meeting minutes and the reports presented to the MARC.
