Published: 6 September 2018

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MARC’s Remarks: July 2018 Meeting

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Prescriber Update 39(3): 45
September 2018

The Medicines Adverse Reactions Committee (MARC) met on 3 July 2018 to discuss a number of medicine-related safety issues.

The MARC discussed benefits and risks of harm of ulipristal acetate (Esmya) under section 36 of the Medicines Act 1981. Ulipristal acetate is indicated for treatment of uterine fibroids in adult women. The MARC considered the risk-benefit balance of ulipristal acetate is favourable only for women where surgery is not an appropriate treatment option.

The MARC reviewed the Risk Management Plan (RMP) for the recombinant meningococcal B vaccine (Bexsero) and considered the RMP to be thorough, appropriate and complete at this time.

The MARC discussed the association between atypical antipsychotics and sleepwalking/sleep-related eating disorder. Given the available evidence, the MARC agreed the association is likely due an individual drug effect rather than a class effect. The Committee recommended the New Zealand data sheets for aripiprazole, olanzapine, paliperidone, quetiapine, risperidone and ziprasidone should include information about these adverse reactions.

A potential drug-drug interaction between nefopam (Acupan) and tramadol was also considered. The MARC recommended a precaution is added to the New Zealand nefopam data sheet. The warning should highlight the potential for serotonin syndrome when nefopam is used concomitantly with any medicine(s) that can increase serotonin availability, including tramadol.

The MARC reviewed two topics relating to isotretinoin.

• Pregnancy prevention measures: The MARC considered increased use of the bestpractice isotretinoin module would help to manage the teratogenic risk of isotretinoin as it includes information about pregnancy prevention. The MARC also recommended pharmacists dispense isotretinoin for women of childbearing potential in the original manufacturer’s pack.
• Obsessive-Compulsive Disorder (OCD): The MARC recommended that this possible association is further investigated through Medsafe’s Medicines Monitoring (M²) system¹.

See the Medsafe website for the MARC meeting minutes (www.medsafe.govt.nz/profs/MARC/Minutes.asp) and the reports presented to the MARC (www.medsafe.govt.nz/committees/MARC/Reports.asp).

References

1. Medsafe. 2018. Isotretinoin and obsessive compulsive disorder. URL: www.medsafe.govt.nz/safety/EWS/2018/Isotretinoin.asp (accessed 15 August 2018).