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Published: 6 September 2013

MARC's Remarks: June 2013 Meeting

Prescriber Update 34(3):34
September 2013

The Medicines Adverse Reactions Committee (MARC) met on 13 June 2013 to review a number of medicine related safety issues.

The MARC discussed a recent review by Medsafe following reported cases of synovitis in association with zoledronate and pamidronate. The MARC considered that the association of bisphosphonates and the risk of synovitis may be under-recognised. The MARC recommended that awareness be raised. Further information can be found in this edition of Prescriber Update1.

The MARC reviewed studies published on diclofenac since the previous MARC review in 2007. The MARC concluded that there was a small increase in the risk of cardiovascular events with the use of diclofenac, particularly with increasing dose and duration of use.

The MARC agreed that the latest studies had a number of limitations and the risk was very low. However, with the widespread use of diclofenac, the MARC agreed that even a small increased risk of cardiovascular adverse effects may translate to a large number of patients potentially affected. Overall, the MARC agreed that the benefit-risk balance of diclofenac remains positive.

The MARC recommended changes to the diclofenac data sheets, package inserts and consumer medicine information. The MARC also recommended that this information be communicated via a Prescriber Update article and by publishing an early warning system alert communication on the Medsafe website2,3.

The MARC reviewed a report on the use of diphtheria, pertussis and tetanus combination vaccine (Tdap, Boostrix®) in pregnant women during the current pertussis epidemic in New Zealand. The MARC agreed that pertussis is an important cause of infant death both in New Zealand and worldwide. The MARC considered that the potential benefits of vaccinating pregnant women with Boostrix outweighed any potential harm.

Further information on these issues can be found on the Medsafe website (www.medsafe.govt.nz/profs/adverse/Minutes154.htm).

References
  1. Medsafe. 2013. Joint swelling associated with zoledronate and pamidronate. Prescriber Update 34(3): 29.
  2. Medsafe. 2013. NSAIDs and risk of cardiovascular events. Prescriber Update 34(3): 26.
  3. Medsafe. 2013. Diclofenac (Voltaren) and risk of cardiovascular events (heart attack and stroke). Alert Communication 8 July 2013. URL: www.medsafe.govt.nz/safety/EWS/2013/diclofenac-cardio.asp (accessed 6 August 2013).
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