Published: 7 March 2024

Publications

MARC’s remarks: December 2023 meeting

Published 7 March 2024
Prescriber Update 45(1): 19–20
March 2024

The Medicines Adverse Reactions Committee (MARC) convened on 7 December 2023.

The Committee reviewed the risk of anticoagulant-related nephropathy (ARN) associated with oral anticoagulants (eg, warfarin, dabigatran, rivaroxaban and apixaban). The Committee noted that the risk of haemorrhage from oral anticoagulants is well-known and that ARN is an indirect effect of glomerular haemorrhage. The Committee agreed there was evidence of a class effect and recommended data sheet updates to include ARN.

The Committee reviewed a potential interaction between the use of estrogen-based hormone replacement therapy (HRT) and reduction in plasma lamotrigine levels. The Committee agreed that, despite limited evidence, there was reasonable biological plausibility to support the interaction. Considering the serious outcomes that may arise from this potential interaction, such as increases in seizure frequency and mood instability, the Committee recommended data sheet updates for estrogen-based HRTs (excluding vaginal preparations).

The Committee reviewed the risk of tendon disorders (including tendonitis, tendosynovitis and tendon rupture) with third-generation aromatase inhibitors (eg, anastrozole, letrozole and exemestane). The Committee considered there was sufficient evidence to support a class effect and recommended that the data sheets be updated to include tendon disorders as a warning and adverse event. There was insufficient evidence to support that tendon disorders with third-generation aromatase inhibitors are confined to a specific location.

The Committee reviewed the risk of tumour lysis syndrome (TLS) with tyrosine kinase inhibitors and monoclonal antibodies when used in cancer treatment. The Committee noted that there is a risk of TLS with any cancer medicine, although the risk depends on the type of cancer and how aggressively the cancer is being treated. The nivolumab, pembrolizumab and midostaurin data sheets do not list TLS. The Committee noted that these medicines are indicated for haematological cancers, which generally have a higher risk of TLS, and recommended data sheet updates to include TLS.

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