Published: 3 March 2022

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MARC’s remarks: December 2021 meeting

Published 3 March 2022
Prescriber Update 43(1): 5
March 2022

The Medicines Adverse Reactions Committee (MARC) convened via videoconference on 2 December 2021.

The Committee discussed the risks and benefits of dihydrocodeine (DHC), an opioid medicine used for pain management, referred under section 36 of the Medicines Act 1981. The Committee considered that there was insufficient evidence to recommend revoking the consent of DHC in New Zealand. However, regulatory actions to improve the safe use of DHC were recommended, including data sheet updates and for the sponsor to supply a Consumer Medicine Information leaflet. The Committee also recommended highlighting to the clinical leaders at the Ministry of Health the inequities in access to pain services and the need for leadership in the correct use of opioids.

The benefits and risks of Buccaline, indicated for the oral antibacterial prophylaxis of complications of colds, were discussed. The Committee considered the potential harms associated with Buccaline, which included using as an alternative to well-studied vaccines or medicines. Overall, the Committee agreed there was a lack of efficacy and safety data and recommended that Medsafe request the sponsor to supply a review of the safety and efficacy of their product under section 36 of the Medicines Act 1981.

The Committee reviewed the risk of bleeding associated with tocopherol (vitamin E). The Committee considered that there is possibly an association, but there was insufficient evidence to support it, and the clinical significance is not known. The Committee recommended that Medsafe contact the sponsors of oral anticoagulants (ie, medicines that are known to cause bleeding) to review a possible interaction between vitamin E and their products.

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