Publications

Published: 6 June 2013

MARC's Remarks: March 2013 Meeting

Prescriber Update 34(2):21
June 2013

The latest meeting of the Medicines Adverse Reactions Committee (MARC) took place on 14 March 2013. The minutes of this meeting are available on the Medsafe website (www.medsafe.govt.nz/profs/adverse/Minutes153.htm).

The MARC reviewed the report following the completion of the Intensive Medicines Monitoring Programme (IMMP) for varenicline (Champix).

The MARC noted that of the top ten adverse events reported in the study, 'nightmare' was the only single event not included in the current New Zealand data sheet. The MARC recommended ‘nightmare’ be added to the Champix data sheet.

The MARC also recommended that the precaution regarding psychiatric events in the data sheet be amended to make it more succinct and clearer. The MARC agreed that the benefit-risk profile of varenicline remains positive.

The MARC reviewed the benefits and risks of calcitonin-containing medicines due to a concern of increased risk of cancer with long-term use. The MARC agreed that the available evidence was insufficient to confirm a causal association between exposure to calcitonin-containing medicines and cancer.

The MARC agreed that the potential association between calcitonin-containing medicines and cancer had the potential to affect the balance of benefits and risks for some of the approved indications. The MARC recommended that data sheet changes be made to reflect this.

The MARC first reviewed the risk of reversible cerebral vasoconstriction syndrome (RCVS) associated with the use of serotonergic agents (Selective serotonin reuptake inhibitors [SSRIs] and/or triptans) in March 2012.

At that time, the MARC concluded that the available evidence was insufficient to confirm a causal association between the use of triptans or SSRIs and the development of RCVS.

The MARC recommended that SSRIs/triptans and RCVS/thunderclap headache be placed on Medsafe's M² logo monitoring scheme. In addition, to raise awareness of RCVS, a Prescriber Update article was published in June 20121.

During the six month M² logo monitoring period, there were three reports of severe or thunderclap headache in patients receiving SSRI or triptan therapy. The MARC recommended that thunderclap headaches and/or RCVS be added to the adverse effects section of all SSRI and triptan data sheets.

The MARC reviewed an updated report investigating concerns about mortality and cardiovascular adverse events with tiotropium (Spiriva). This follows the publication of two recent editorials calling for the withdrawal of the Spiriva Respimat inhaler2,3.

The MARC noted that the Respimat inhaler is not available in New Zealand and that to date no concerns have been raised with the currently available tiotropium powder formulation.

The MARC agreed that cardiovascular issues with the Respimat mist inhaler may be a signal. However, the Committee agreed that the benefit/risk profile of Spiriva had not changed since the last MARC review in 2011. The MARC supported the manufacturer’s decision to not market the Respimat product in New Zealand until the results of the TioSpir study are available.

Reference
  1. Medsafe. 2012. Reversible Cerebral Vasoconstriction Syndrome — Medicine Induced? Prescriber Update 33(2): 14–5. URL: www.medsafe.govt.nz/profs/PUArticles/ReversibleCerebralVasoconstrictionSyndromeJune2012.htm (accessed 15 may 2013).
  2. Beasley R, Singh S, Loke YK, et al. 2012. Call for worldwide withdrawal of tiotropium Respimat mist inhaler. BMJ 345: e7390.
  3. Jenkins CR, Beasley R. 2013. Tiotropium Respimat increases the risk of mortality. Thorax 68: 5–7.