Published: 2 June 2022


MARC’s remarks: March 2022 meeting

Published 2 June 2022
Prescriber Update 43(2): 19
June 2022

The Medicines Adverse Reactions Committee (MARC) convened via videoconference on 10 March 2022.

The Committee reviewed the risk of drug-induced liver injury (DILI) with glucagon-like peptide-1 receptor agonists (GLP1-RAs). The Committee did not consider that the current evidence supports an association between GLP1-RAs and DILI. The Committee recommended removing the requirement for monitoring of liver enzymes from the liraglutide data sheet to align with the product information for other GLP1-RAs.

The Committee discussed the use of venlafaxine in pregnancy and whether the current evidence supports an increased risk of congenital malformations or gestational hypertension. The Committee agreed that the risk of gestational hypertension is biologically plausible, and while the available evidence may suggest an association, it is inconclusive. The Committee considered that the existing information on hypertension and gestational diabetes in the venlafaxine data sheets is sufficient. The Committee noted that the data sheets include the Australian ‘Pregnancy – Category B2’ heading. However, pregnancy category B2 is not consistent with the information in the data sheets on congenital abnormalities, and the Committee recommended removing the heading. The Australian pregnancy categorisation system is no longer used in New Zealand clinical practice and is not required in New Zealand data sheets.

The Committee reviewed the safety of non-steroidal anti-inflammatory drug (NSAID) exposure during the third trimester of pregnancy. The Committee recommended this review following the September 2021 meeting where they discussed the safety of NSAIDs during the second trimester. At that meeting, the Committee noted that the NSAID data sheets had inconsistent information regarding safety during the third trimester and recommended reviewing this topic at a future meeting. At the March 2022 meeting, the Committee concluded that all NSAIDs should be contraindicated in the third trimester of pregnancy. They recommended that Medsafe consult with the Committee to develop information for all NSAID data sheets that reflects the risks of use throughout pregnancy. This information will also be communicated in Prescriber Update when available.

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

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