Published: 2 September 2021
Publications
MARC’s remarks: June 2021 meeting
Published: 2 September 2021
Prescriber Update 42(3): 35
September 2021
The Medicines Adverse Reactions Committee (MARC) convened via videoconference on 10 June 2021.
Due to serious skin reactions reported overseas, medicines containing bufexamac were referred to the Committee under section 36 of the Medicines Act 1981. Bufexamac is a non-steroidal anti-inflammatory medicine for topical application and is a general sale medicine in strengths 5% or less. The Committee considered that medicines containing bufexamac had an unfavourable risk-benefit profile and recommended to the Minister’s delegate that the consent to distribute these medicines be revoked. In addition, the Committee recommended that Medsafe make an application to the Medicines Classifications Committee to review the classification of bufexamac.
The Committee discussed concerns associated with the use of medicines with boron-containing excipients in children and a potential impact on fertility later in life. The Committee noted that the evidence for fertility concerns associated with boron use was based on animal studies and appeared to be dose related. The relevance to humans was uncertain. The Committee recommended data sheet updates for medicines with boron-containing excipients to reflect what is known from animal and human studies.
The misuse of stimulant laxatives in New Zealand was discussed. The Committee recommended that Medsafe undertake a consultation regarding adding warning and advisory statements on the manufacturers’ original pack for all stimulant laxatives.
The Committee considered regulatory options for minimising opioid misuse, abuse and dependence in New Zealand. Several regulatory actions were recommended by the Committee, such as updating the data sheets, adding new warning labels, enhanced safety monitoring, and communication activities. The Committee questioned the clinical benefits of dihydrocodeine and its role in pain management and recommended that Medsafe undertake a risk benefit review.
See the Medsafe website for the MARC meeting minutes and the reports presented to the MARC.
