Published: 7 December 2023

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MARC's remarks: September 2023 meeting

Published: 7 December 2023
Prescriber Update 44(4): 79
December 2023

The Medicines Adverse Reactions Committee (MARC) convened on 14 September 2023.

The risk of toxicity in younger children and infants with oromucosal lidocaine containing products was reviewed. The Committee agreed that the risk of toxicity in this age group was dose related and that the greatest risk was from accidental overdose or when the package label instructions were not followed correctly. The Committee also questioned whether the current classification of these products was appropriate. The Committee recommended referral of oromucosal lidocaine products to the Medicines Classification Committee for review of the classification and whether mandatory label statements are needed.

The Committee reviewed whether there was a class association between glucagon-like peptide-1 receptor agonists (GLP-1 RAs) or dipeptidyl peptidase-4 (DPP-4) inhibitors and intestinal obstruction (including ileus). Given the known effect on gastrointestinal motility with GLP-1 RAs, the Committee recommended data sheet updates to include the risk of intestinal obstruction (including ileus) for this class of medicines. The Committee considered that more data is needed for DPP-4 inhibitors, and recommended that Medsafe publish a monitoring communication to collect more information.

The risk of QT prolongation and torsade de pointes with acetylcholinesterase inhibitors (donepezil, rivastigmine and galantamine) was discussed. The Committee agreed that the available evidence supports a relationship between acetylcholinesterase inhibitors and QT prolongation and torsade de pointes, and recommended data sheet updates to describe this risk.

Following new safety measures announced in the United Kingdom,¹ the Committee reviewed the available information on oral isotretinoin and the risk of psychiatric disorders and sexual dysfunction. The Committee noted the risk of psychiatric disorders with isotretinoin has been well-studied and a clear attributable effect has not been established. The Committee considered that the evidence supporting the risk of sexual dysfunction with isotretinoin was not strong. However, data sheet updates were recommended to include vulvovaginal dryness as an adverse reaction and modification of certain psychiatric terms. The Committee also recommended that Medsafe contact the sponsor to review the data sheet dosing information as it differs from local clinical guidelines.

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

Reference

1. Medicines and Healthcare products Regulatory Agency (MHRA). 2023. Isotretinoin (Roaccutane): new safety measures to be introduced in the coming months, including additional oversight on initiation of treatment for patients under 18 years 26 April 2023. URL: gov.uk/drug-safety-update/isotretinoin-roaccutanev-new-safety-measures-to-be-introduced-in-the-coming-months-including-additional-oversight-on-initiation-of-treatment-for-patients-under-18-years (accessed 20 October 2023).