Published: 3 September 2026
Publications
MARC’s remarks: June 2026 meeting
Published: 3 September 2026
Prescriber Update 47(3): 45
September 2026
The Medicines Adverse Reactions Committee (MARC) convened for their 206th meeting on 11 June 2026.
The Committee discussed the safety of colecalciferol 50,000 IU capsules in pregnancy. They noted that all overseas product information for similar products either contraindicate use in pregnancy, or state that use is not recommended and a lower-dose formulation should be used. The Committee acknowledged there may be a clinical need for the use of high doses of vitamin D in pregnancy in specific circumstances but considered that such cases should be managed on an individual basis with specialist advice where appropriate. No changes to the safety information in the data sheet were recommended.
The Committee discussed paternal exposure to low-dose methotrexate. Because the contraceptive advice for methotrexate is consistent with regulatory guidance on genotoxic medicines, the Committee agreed that the current recommendation contraception in men during treatment and for three months after cessation should be retained in the data sheet. However, the data sheet should be updated to reflect the current evidence that preliminary studies have not demonstrated an increased risk of congenital malformations or adverse pregnancy outcomes with paternal exposure to low‑dose methotrexate, but a small risk cannot be excluded.
The Committee discussed sexual dysfunction following discontinuation of serotonin reuptake inhibitors (SSRI/SNRI). The Committee was not in favour of adding the term ‘post-SSRI sexual dysfunction’ to data sheets. However, they considered that there would be benefit in reviewing the specific symptoms of sexual dysfunction that have been reported, including whether they continue following discontinuation of treatment. The Committee recommended that Medsafe present a review of specific symptoms of sexual dysfunction with serotonin reuptake inhibitors at a future meeting.
See the Medsafe website for the MARC meeting minutes and the reports presented to the MARC.
