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Published: 7 September 2017

MARC’s Remarks: June 2017 Meeting

Prescriber Update 38(3): 40-41
September 2017

The Medicines Adverse Reactions Committee (MARC) met on 8 June 2017 to discuss a number of medicine-related safety issues.

The MARC discussed the safety of antibiotic ear drops in children with grommets. The MARC discussed the risk of ototoxicity when used in children with grommets or with a perforated tympanic membrane and differences in the risk of ototoxicity between different antibiotic-containing ear drops. The MARC considered the available evidence suggests that ciprofloxacin-containing ear drops have less toxicity than other antibiotic-containing ear drops and recommended updates to data sheets.

The MARC discussed the risk of spontaneous abortion from the use of non-steroidal anti-inflammatory drugs (NSAIDs). The MARC considered the strength of the evidence to be equivocal for an association between NSAIDs and spontaneous abortion at this time. However, the MARC considered that a woman who is trying to get pregnant would want to know that spontaneous abortion from the use of NSAIDs is a potential concern and recommended updates to data sheets and labelling.

The MARC discussed the risk of major haemorrhage or ischaemic stroke from the use of statins in patients taking dabigatran. The MARC identified a number of limitations and confounding factors in the evidence presented to them and overall considered the strength of the available evidence to be weak. The MARC did not consider the evidence suggests a clinically relevant interaction between dabigatran and statins.

The MARC reviewed available evidence on the risk of gadolinium accumulation in the brain after use of gadolinium-based contrast agents. The available evidence indicates that gadolinium is deposited in the brain after administration of gadolinium-based contrast agents. However, the MARC did not consider there was evidence of harm from deposition of gadolinium. Healthcare professionals and consumers should nonetheless be informed about this safety concern.

The MARC noted the United States Food and Drug Administration (FDA) has revised the contraindications for tramadol-containing products. Its use is restricted in children younger than 18 years to treat pain after surgery to remove the tonsils and/or adenoids1. The MARC discussed the use of tramadol in New Zealand and considered there is value in tramadol being available for use post-operatively. However, it is important to monitor for signs of toxicity or overdose when tramadol is used following recent tonsillectomy, adenoidectomy and throat surgery.

Further information on the meeting held on 8 June 2017 can be found on the Medsafe website (www.medsafe.govt.nz/profs/adverse/Minutes170.htm). As of this meeting, papers presented to the MARC will be published on the Medsafe website (www.medsafe.govt.nz/committees/MARC/Reports.asp).

References
  1. Food and Drug Administration. 2017. FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women. FDA Drug Safety Communication. April 2017. URL: fda.gov/Drugs/DrugSafety/ucm549679.htm (accessed 11 July 2017).
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