Published: 8 June 2018

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MARC’s Remarks: March 2018 Meeting

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Prescriber Update 39(2): 27-28
June 2018

The Medicines Adverse Reactions Committee (MARC) met on 8 March 2018 to discuss a number of medicine-related safety issues.

The MARC noted a case reported to the Centre for Adverse Reactions Monitoring (CARM) regarding the effects of stopping smoking on theophylline. Interactions between medicines and smoking have been described in a previous edition of Prescriber Update¹ and a Consumer Information Leaflet².

The MARC also noted a case of hypocalcaemia following a zoledronic acid infusion. Further information is available in this edition of Prescriber Update³ .

The MARC discussed the latest evidence for levonorgestrel and its weight-based efficacy. The current information was insufficient for MARC to make a recommendation on the benefit of using an unapproved dose (3 mg) of levonorgestrel in women over 70 kg or a body mass index greater than 26 kg/m² . The MARC and Medsafe remind health professionals that patients must give informed consent before using this unapproved dose.

The MARC discussed the safety of codeine in children. Further information on the recommendations made by the MARC is available in this edition of Prescriber Update⁴ .

The MARC was presented with a case report where a woman experienced discontinuation symptoms upon stopping her three-monthly medroxyprogesterone depot injection (brand name Depo-Provera). The MARC noted that while there is limited information on this issue in the medical literature, there are many reports on social media platforms where women discuss problems upon stopping Depo-Provera. The MARC determined that the evidence was too weak to require data sheet updates, however health professionals should always discuss the potential risks and discontinuation effects that women may experience from this medicine.

The MARC was asked to comment on a request by the sponsor to change the contraindications and precautions in the celecoxib data sheet regarding use in patients with cardiovascular conditions. The MARC asked Medsafe to request further information from the manufacturer before recommendations can be made.

The MARC was presented with the Risk Management Plan (RMP) for nusinersen, which is a novel, antisense oligonucleotide medication for the management of spinal muscular atrophy. The RMP was considered to be thorough, appropriate and complete.

The MARC discussed a potential association between ulipristal acetate and drug-induced liver injury. The MARC discussed individual cases and agreed that there was an association between the medicine and the adverse drug reaction. The MARC recommended that Medsafe conducts a risk-benefit review of ulipristal acetate under section 36 of the Medicines Act 1981.

Further information on this meeting is available on the Medsafe website (www.medsafe.govt.nz/profs/adverse/Minutes173.htm). The reports presented to the MARC are also available (www.medsafe.govt.nz/committees/MARC/Reports.asp).

References

1. Medsafe. 2013. Smoking can interact with medicines. Prescriber Update 34(4): 41–2. URL: www.medsafe.govt.nz/profs/PUArticles/PDF/PrescriberUpdate_December2013.pdf(accessed 19 April 2018).
2. Medsafe. 2016. Quitting smoking can affect the medicines you are taking. URL: www.medsafe.govt.nz/consumers/educational-material/QuittingSmokingCanAffectYourMedicines.pdf (accessed 19 April 2018).
3. Medsafe. 2018. Hypocalcaemia – a risk with zoledronic acid. Prescriber Update 39(2): 24–5.
4. Medsafe. 2018. Spotlight on Codeine. Prescriber Update 39(2): 18–19.