Published: 15 December 2014

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MARC's Remarks: September 2014 Meeting

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Prescriber Update 35(4): 54
December 2014

The Medicines Adverse Reactions Committee (MARC) met on 11 September 2014 to review a number of medicine-related safety issues.

The MARC reviewed information on the risk of cardiovascular events (myocardial infarction, venous thromboembolism and stroke) with testosterone replacement therapy. Further information can be found in this edition of Prescriber Update¹.

The MARC initiated a discussion on the possible mechanisms for migration and related complications with Jadelle subcutaneous implants, including insertion technique, implant location difficulties, the effect of subcutaneous fat, and the quality of the device. The MARC requested further information and will discuss this topic again at the next meeting.

Data on efficacy and safety of bromocriptine when used to treat premenstrual symptoms and mastalgia were reviewed by the MARC. The MARC noted there was very little information available to support the use of bromocriptine in these indications. Therefore, the MARC recommended that the indications for treating premenstrual symptoms and mastalgia be removed from the bromocriptine data sheet.

The MARC reviewed the available information on the possible association between macrolides and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). The MARC considered that there was insufficient evidence to support this association.

The publication of a meta-analysis on the use of oseltamivir by Jefferson et al in the British Medical Journal was reviewed by the MARC. The MARC noted that there were significant limitations to this analysis. Therefore, the MARC concluded that no action or change to current advice was required regarding the safety and effectiveness of oseltamivir as a result of this meta-analysis.

Further information on these issues can be found on the Medsafe website (www.medsafe.govt.nz/profs/adverse/Minutes159.htm).

References

1. Medsafe. 2014. Pump up Testosterone Levels Safely. Prescriber Update 35(4): 52