Published: 6 December 2019
Publications
MARC’s Remarks: September 2019 meeting
Prescriber Update 40(4): 81December 2019
The Medicines Adverse Reactions Committee (MARC) met on 12 September 2019 to discuss a number of medicine-related safety issues.
Based on case 132801 reported to the Centre for Adverse Reactions Monitoring (CARM), the MARC recommended that a submission is made to the Medicines Classification Committee to review the classification of Bonjela (choline salicylate).
The MARC discussed benefits and risks of harm of Cafergot (ergotamine tartrate + caffeine) under section 36 of the Medicines Act 1981. Cafergot is indicated for the treatment of acute attacks of migraine with or without aura in adults. The MARC considered the benefits of use of Cafergot no longer outweigh the risks of harm. The MARC therefore recommended that consent to distribute Cafergot in New Zealand be revoked. The MARC recommended a 6-month transition period to enable patients to change to alternative treatment.
The MARC discussed the use of topiramate for migraine prevention during pregnancy and recommended that topiramate should not be used to treat migraine in women of child bearing potential unless they are taking adequate contraception.
The MARC discussed serotonin reuptake inhibitors and the risk of persistent sexual dysfunction. The MARC recommended data sheet updates to outline this risk for serotonin reuptake inhibitor products.
A benefit-risk review of dextromethorphan was also considered. The MARC discussed the available evidence presented to them and considered that, although marginal, the benefit-risk balance was favourable. The MARC recommended that data sheets should contain information on dependence, serotonin syndrome and overdose for dextromethorphan-containing products. The MARC noted they are fully in favour of the reclassification of dextromethorphan to Pharmacist Only.
The MARC reviewed the Risk Management Plan (RMP) for the recombinant varicella zoster virus vaccine (Shingrix) and considered the RMP to be thorough, appropriate and complete at this time.
See the Medsafe website for the MARC meeting minutes and the reports presented to the MARC.
