Published: 7 September 2023
Publications
MARC’s remarks: June 2023 meeting
Published: 7 September 2023
Prescriber Update 44(3): 58
September 2023
The Medicines Adverse Reactions Committee (MARC) convened on 8 June 2023.
The Committee reviewed the efficacy of molnupiravir (Lagevrio) and agreed that molnupiravir appears to be less effective than nirmatrelvir/ritonavir (Paxlovid) against the current variants of concern of COVID-19. However, there are some benefits in reducing symptom severity, reducing viral load and accelerating recovery time. The Committee acknowledged that molnupiravir may be appropriate in cases where alternative COVID-19 therapeutics are not suitable or available. The Committee agreed that the available evidence on the efficacy of molnupiravir supports its current indication.
The Committee reviewed the safety and efficacy of pholcodine. A recent study found that exposure to this medicine increases the risk of perioperative anaphylaxis with neuromuscular blocking agents (NMBA) used in surgery.1 Overall, the Committee considered there was evidence of an association between previous pholcodine use and an increased risk of anaphylaxis from NMBA administration. Whilst the risk of anaphylaxis may be small, it can be a serious and life-threatening event. The Committee agreed that the risk minimisation measures proposed by the company were not sufficient to manage this risk and recommended to the Minister’s delegate that the consent for pholcodine be revoked under Section 35 of the Medicines Act 1981 due to safety concerns. The available efficacy data was considered limited.
The Committee reviewed the Risk Management Plan for Epidyolex, an oral cannabidiol medicine indicated for certain severe types of epilepsy. The Committee noted the risk of hepatotoxicity with this medicine but considered that the sponsor’s ongoing monitoring and risk minimisation measures were appropriate. The Committee were satisfied with the Epidyolex Risk Management Plan.
Medsafe updated the Committee on the signal evaluation of pericarditis following mpox vaccination. The Committee noted Medsafe’s plan to continue monitoring this safety concern.
See the Medsafe website for the MARC meeting minutes and the reports presented to the MARC.
Reference
- Mertes PM, Petitpain N, Tacquard C, et al. 2023. Pholcodine exposure increases the risk of perioperative anaphylaxis to neuromuscular blocking agents: the ALPHO case-control study. British Journal of Anaesthesia 131(1): 150–8. DOI: https://doi.org/10.1016/j.bja.2023.02.026.
