Published: 3 September 2020


MARC’s remarks: June 2020 meeting

Published: 3 September 2020
Prescriber Update 41(3): 58–59
September 2020

See the Medsafe website for the MARC meeting minutes and the reports presented to the MARC.

The Medicines Adverse Reactions Committee (MARC) met on 11 June 2020 to discuss a number of medicine-related safety concerns.

The MARC discussed the possible association of fluconazole use in pregnancy, including single-dose treatment for vulvovaginal candidiasis, with spontaneous abortion and congenital malformations. The MARC recommended that the data sheets should be updated to include information on the effects of low-dose fluconazole treatment during pregnancy and that the pregnancy information should be harmonised across all data sheets.

The MARC discussed the use of oral sedating antihistamines in children for sedation. The MARC recommended that the indication for sedation of children be removed from over-the-counter medicines containing sedating antihistamines.

The MARC discussed the risk of serious liver injury in patients with advanced liver disease who are treated with hepatitis C medicines, including Maviret. The MARC recommended data sheet updates to strengthen the warning not to use Maviret in patients with advanced liver disease. For more information, see the Maviret article in this edition of Prescriber Update.

The MARC discussed the available evidence relating to associations between antiepileptic medicines and neurodevelopmental disorders. The Committee recommended Medsafe writes to the sponsor about the possible association between lamotrigine and the development of autism spectrum disorder in children exposed in utero and whether this information should be included in the data sheet.

Note that ACC, the Health Quality and Safety Commission, the Ministry of Health and Foetal Anti-Convulsant Syndrome New Zealand (FACS NZ) have released updated information resources about the benefits and risks of anti-seizure/mood stabilising medicines for people who could become pregnant. The resources can be downloaded or ordered from ACC – see the Fetal Anticonvulsant Syndrome section.

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