Published: 5 March 2026
Publications
MARC’s remarks: December 2025 meeting
Published: 5 March 2026
Prescriber Update 47(1): 5
March 2026
The Medicines Adverse Reaction Committee (MARC) convened for their 204th meeting on 4 December 2025.
The Committee discussed the risk of psychiatric disorders with cystic fibrosis transmembrane conductance regulator (CFTR) modulators. CFTR modulators include ivacaftor (Kalydeco) and ivacaftor/tezacaftor/elexacaftor (Trikafta). The Committee agreed that while a causal relationship has not been established, the data sheets for CFTR modulators should be updated to state that psychiatric disorders have been reported and that patients should be monitored for these symptoms.
The Committee discussed antipsychotic-induced hyperprolactinemia and the risk of breast cancer. The Committee considered that there was biological plausibility for an association, but the epidemiological evidence was unconvincing. The current data sheet information was considered appropriate, and no regulatory action was recommended.
The Committee reviewed the risk of drug reaction with eosinophilia and systemic symptoms (DRESS) with calcium channel blockers. The Committee considered the evidence for an association to be limited and concluded that no regulatory action is needed.
Medsafe presented a summary of New Zealand adverse reaction reports for pregabalin. The Committee noted that usage of pregabalin is increasing in New Zealand and commented that misuse and abuse of pregabalin is a significant problem internationally.
See the Medsafe website for the MARC meeting minutes and the reports presented to the MARC.
