Published: 1 September 2022
Publications
MARC’s remarks: June 2022 meeting
Prescriber Update 43(3): 37
September 2022
The Medicines Adverse Reactions Committee (MARC) convened on 9 June 2022.
The Committee reviewed the risk of developing serotonin syndrome from taking an opioid in combination with another serotonergic medicine. The Committee considered that this risk differed between different opioids. The Committee recommended that where the interaction is clinically significant, the opioid data sheets should have a standardised warning statement on the risk of serotonin syndrome when taken with a serotonergic medicine. This includes the data sheets for opioids that are high risk (tramadol, pethidine and dextromethorphan) and those that are medium risk (higher doses of fentanyl and methadone). The Committee also recommended updates to the serotonergic medicine data sheets to reflect this interaction. See the Opioids and serotonergic medicines article in this edition of Prescriber Update.
The risk of birth defects and fetal cardiac malformations with methylphenidate exposure in the first trimester was discussed. The Committee considered that recent observational studies did not suggest an overall increased risk of birth defects. However, one study showed a small increased risk of cardiac malformations. The Committee recommended data sheet updates to reflect this study’s results and to emphasise that prescribers should discuss the medicine’s benefits and risks with the individual.
The Committee reviewed the risk of prostaglandin-associated periorbitopathy (PAP) with the ocular prostaglandin analogues: bimatoprost, latanoprost and travoprost. The Committee considered that the overall evidence indicated a class effect and that bimatoprost had the highest risk of PAP. The Committee recommended updates to the ocular prostaglandin analogue data sheets to include information on PAP. See also the Prostaglandin-associated periorbitopathy article in this edition of Prescriber Update.
The benefits and risks of methenamine hippurate were discussed. The Committee noted that the current evidence supporting its efficacy for the suppression or elimination of urinary tract bacteria is weak. However, it may play a role in antimicrobial stewardship. Overall, the Committee considered the risk-benefit balance was favourable. The Committee recommended that the sponsor provide a data sheet and consumer medicine information leaflet to ensure appropriate information is available for healthcare professionals and consumers. The Committee also considered that patients with recurrent urinary tract infection symptoms should consult with a healthcare professional. They recommended that the Medicines Classifications Committee review the general sale classification of methenamine hippurate.
See the Medsafe website for the MARC meeting minutes and the reports presented to the MARC.
