Published: 4 March 2021


MARC’s remarks: December 2020 meeting

Published: 4 March 2021
Prescriber Update 42(1): 6
March 2021

The Medicines Adverse Reactions Committee (MARC) convened via videoconference on 3 December 2020.

The Committee reviewed three potential safety concerns with gabapentin and pregabalin: misuse, abuse and dependence; opioid-related death and respiratory depression; and use in elderly patients. The Committee recommended more prescriber education is required to reduce the inappropriate prescribing of these medicines for chronic non-neuropathic pain (such as lower back pain), and to highlight the potential for misuse (see the Spotlight article). The Committee also recommended that Medsafe write to the sponsors of these medicines to strengthen the data sheet wording on some of these potential safety concerns.

The Committee reviewed the available data on opioid use to ascertain if there is a problem of abuse, misuse and dependence in New Zealand or a recent increase in this problem. The Committee noted from the global data that New Zealand is doing comparatively well, but more work is required to reduce the issue of abuse, misuse and dependence. The Committee recommended potential regulatory actions and education to raise prescriber awareness of these issues.

The Committee discussed the use of HER2 and CD receptor-targeted monoclonal antibodies and the risk of interstitial lung disease. The Committee noted that a link was difficult to establish because of potential confounding from the underlying disease and concomitant medicines. Currently there is limited information available and only a small number of cases reported in New Zealand. The Committee recommended that sponsors review the risk of interstitial lung disease as part of their routine benefit-risk evaluation reports for pertuzumab, daratumumab and obinutuzumab. 

The Committee considered the available evidence of congenital malformation when tricyclic antidepressants (TCAs) are taken in the first trimester of pregnancy. The Committee concluded that the current evidence is inconclusive and that the data sheets for TCAs should reflect this uncertainty. The Committee also pointed out that it is essential for prescribers to discuss the benefits and the risk of harm with women who take TCAs to enable them to make informed decisions about use in pregnancy.

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

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