Published: 2 March 2023

Publications

MARC's remarks: December 2022 meeting

Published: 2 March 2023
Prescriber Update 44(1): 10–11
March 2023

The Medicines Adverse Reactions Committee (MARC) convened on 1 December 2022.

The Committee reviewed the risk of neurotoxicity with cephalosporin antibiotics. Although the available data is limited, the Committee considered an association between neurotoxicity and the cephalosporin class cannot be discounted. They agreed that recognition of neurotoxicity in patients taking cephalosporins may be challenging. The Committee recommended that all cephalosporin data sheets should include consistent messaging on the risk of neurotoxicity. See the Risk of neurotoxicity with cephalosporins article in this edition of Prescriber Update.

The safety of pregabalin when taken during pregnancy was discussed. European prescribing information has been updated to include the results of a Nordic observational study that suggested that the risk of major congenital malformations (MCM) among children exposed to pregabalin in the first trimester of pregnancy was slightly higher compared to unexposed children. However, this association was no longer statistically significant after adjusting for confounding factors.¹

The Committee noted that the current pregabalin data sheet includes a strong warning that use in the first trimester of pregnancy may cause major birth defects in the unborn child and that pregabalin should not be used during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the fetus. The Committee considered that the study results did not change or strengthen this warning, and there was no need to update the data sheet information on use in pregnancy at this time. The Committee recommended that the safety of pregabalin in pregnancy should continue to be monitored and reviewed again as new information becomes available.

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

Reference

1. European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCEPP). 2020. A Population based Cohort Study of Pregabalin to Characterize Pregnancy Outcomes - final study report 1 June 2020. URL: eu/encepp/viewResource.htm?id=36881 (accessed 16 September 2022).