Published: 4 June 2020

Publications

MARC’s Remarks: March 2020 meeting

Prescriber Update 41(2): 30
June 2020

The Medicines Adverse Reactions Committee (MARC) met on 12 March 2020 to discuss a number of medicine-related safety issues.

The MARC discussed dosing of paracetamol in obese children and if specific dosing instructions for this group of patients should be included in the data sheets and/or label statements. The MARC considered there is very limited data available on the pharmacokinetics of paracetamol or cytochrome P450 activity in obese children. The MARC determined there is insufficient evidence to recommend an update to the paracetamol data sheets and/or label statements.

The MARC discussed ondansetron exposure in utero and the risk of cleft palate. The MARC considered that there is some evidence suggesting a slightly increased risk of cleft palate when ondansetron is taken during the first trimester of pregnancy. The MARC considered this small risk should be highlighted in New Zealand data sheets. The MARC also recommended that the Committee’s discussion is highlighted to the Society of Obstetric Medicine of Australia and New Zealand and included in a future edition of Prescriber Update (see the Ondansetron article in this edition of Prescriber Update).

The MARC reviewed the benefits and risks of Tdap vaccine (Boostrix) when administered to women in their second trimester of pregnancy. The MARC determined that the data did not indicate that use in the second trimester would expose pregnant women to additional risks and recommended a data sheet update to include this information.

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