Published: 4 June 2026
Publications
MARC’s remarks: March 2026 meeting
Published: 4 June 2026
Prescriber Update 47(2): 25
June 2026
The Medicines Adverse Reactions Committee (MARC) convened for their 205th meeting on 12 March 2026.
The Committee discussed the safety profile for melatonin in adults. They considered that potential safety signals, such as serotonin syndrome and suicidality, are likely to be confounded by the person’s underlying sleep-related conditions and concomitant medicines. The Committee noted the extensive long-term international use of melatonin, including at higher doses, provides a reasonable level of confidence in its overall safety profile and no regulatory action was recommended.
The Committee discussed the safety of vitamin B6 (pyridoxine) and noted that peripheral neuropathy was the main safety concern. The Committee discussed the limitations of the current regulatory framework, noting that some products that are marketed as dietary supplements fall outside the Medicines Act 1981, yet may contain doses of vitamin B6 that exceed those usually prescribed for therapeutic indications. The Committee considered setting a limit/maximum daily dose of vitamin B6 in dietary supplements, requiring label statements about peripheral neuropathy, and changing the classification to reduce the amount of vitamin B6 permitted in general sale medicines and dietary supplements would be beneficial. The Committee acknowledged that these considerations are outside of their remit and so will communicate them to relevant organisations.
The Committee reviewed the updated medical literature on menopausal hormone therapy (MHT) and the risk of breast cancer, cardiovascular disease and cognitive impairment. They noted that the recent published literature did not change the existing understanding of these risks, and no regulatory action was recommended. The Committee commented that MHT provides substantial benefit in reducing vasomotor symptoms for many women. MHT has additional risks and/or benefits that are relevant for some women but contributes small absolute risk differences in most cases.
See the Medsafe website for the MARC meeting minutes and the reports presented to the MARC.
