Publications

Published: 5 September 2014

MARC's Remarks: June 2014 Meeting

Prescriber Update 35(3): 40
September 2014

The Medicines Adverse Reactions Committee (MARC) met on 12 June 2014 to review a number of medicine related safety issues.

The MARC reviewed information from a statutory benefit risk review of hydroxyethyl starch. The MARC noted that action had already been taken to restrict the use of these medicines and considered that no further regulatory action is required at this time1.

The MARC reviewed the benefits and risks of treatment with strontium ranelate. The MARC noted that action had already been taken to restrict the use of this medicine and considered that no further regulatory action is required to improve the balance of benefits and risks of strontium ranelate at this time2.

The benefits and risks of domperidone were also reviewed by the MARC. Medsafe is currently working with the relevant sponsors to update these data sheets. An update will be provided in a future edition of Prescriber Update.

The MARC discussed the risk of long-lasting erections (priapism) with the use of methylphenidate. Further information can be found in this edition of Prescriber Update3.

Finally, the MARC discussed levonorgestrel emergency contraception and weight-based efficacy.

The MARC noted that the two randomised controlled trials used in the meta-analysis were not initially designed to examine the effect of body weight on the effectiveness of emergency contraception.

The MARC suggested that data sheets and consumer medicine information for emergency contraceptives containing levonorgestrel should include information on weight-based efficacy.

The MARC recommended that these medicines remain a suitable treatment option for women requiring emergency contraception. The MARC noted that women should use emergency contraception as soon as possible after intercourse as efficacy declines over time.

Further information on these issues can be found on the Medsafe website (www.medsafe.govt.nz/profs/adverse/Minutes158.htm).

References:
  1. Medsafe. 2014. Hydroxyethyl starch (Voluven and Volulyte 6%) — review of benefits and risks of harm. Trans-Tasman Early Warning System - Alert Communication. URL: www.medsafe.govt.nz/safety/EWS/2014/Hydroxyethyl-starch-solutions.asp (accessed 25 July 2014).
  2. Servier Laboratories (New Zealand) Limited. 2014. Protos data sheet. 2 April 2014. URL: www.medsafe.govt.nz/profs/datasheet/p/Protossusp.pdf (accessed 25 July 2014).
  3. Medsafe. 2014. The hard facts on drug-induced priapism (long-lasting erections). Prescriber Update 35(3): 34