Published: 12 December 2013

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MARC's Remarks: September 2013 Meeting

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Prescriber Update 34(4): 45-46
December 2013

The Medicines Adverse Reactions Committee (MARC) met on 12 September 2013 to review a number of medicine related safety issues.

The MARC reviewed the safety of hydroxyethyl starch containing solutions following concerns about mortality and renal injury.

The MARC noted that the meta-analyses and clinical studies had limitations sufficient to preclude a firm conclusion being made on the benefits and risks of these medicines in critically ill patients. The use in surgical patients did not raise any safety concerns.

The MARC considered that there were differences in the effects of different starches and recommended that a statutory benefit risk review should be performed.

The MARC reviewed recently published studies that indicated a direct increased risk of acute kidney injury or renal failure with the use of high-potency statins. The MARC concluded that the evidence that statins cause acute kidney injury through a direct effect rather than secondary to rhabdomyolysis was weak and the balance of benefits and risks of harm for statins remains positive.

The MARC agreed that more information would be valuable and that the topic of acute kidney injury, not associated with rhabdomyolysis, be added to Medsafe's scheme.

The MARC reviewed the use of N-acetylcysteine in the treatment of paracetamol overdose following changes to the United Kingdom guidelines. The MARC noted the efficacy of n-acetylcysteine and recommended changing the data sheet indications to state more clearly when N-acetylcysteine could be used.

In addition, the MARC recommended removal of the hypersensitivity contraindication, using the Australasian poisons centres recommended treatment nomogram, adding weight based dosing tables and adding additional information on adverse effects.

Calcium supplements and the risk of adverse cardiovascular outcomes was also reviewed by the MARC. The MARC concluded that there is insufficient evidence to support an association between the use of calcium supplements and adverse cardiovascular outcomes. Further information can be found in this edition of Prescriber Update¹.

The MARC discussed a Medsafe risk-benefit review of propofol when used to sedate paediatric patients undergoing ICU care. After reviewing the available data, the MARC concluded that the benefits of short term propofol use outweigh the potential risks. The MARC recommended that all propofol data sheets be updated to include more detailed information on the risk of propofol related infusion syndrome occurring.

Further information on these issues can be found on the Medsafe website (www.medsafe.govt.nz/profs/adverse/Minutes155.htm).

References

1. Medsafe. 2013. Do Calcium Supplements Increase Cardiovascular Risk? Prescriber Update 34(4): 40.