Publications

Published: May 2009

Cough and cold products - an update

Prescriber Update 30(2): 11
May 2009

MUST NOT BE USED IN CHILDREN UNDER TWO YEARS OF AGE

Healthcare professionals will recall that following a review of the safety and efficacy of cough and cold products in children in December 2007, the MARC considered that the risk-benefit profile of these products is unfavourable for children under two years of age.

The MARC recommended that cough and cold products be contraindicated in children under two years of age based on limited evidence for efficacy in this age group, an absence of evidence-based dosing, and evidence of significant toxicity in overdose.

Medsafe has been working together with New Zealand sponsors to amend the product packaging for cough and cold products. Affected products will now include the statement "Must not be used in children under two years of age", or words to this effect.

The packaging amendments are required for all cough and cold products containing bromhexine, brompheniramine, chlorphenamine, dextromethorphan, diphenhydramine, doxylamine, guaifenesin, ipecacuanha, oxymetazoline, phenylephrine, pholcodine, promethazine, pseudoephedrine, triprolidine and xylometazoline. A list of currently marketed cough and cold products (as at 1 March 2009) that require the new warning is provided on the Medsafe web site: www.medsafe.govt.nz/hot/alerts/CoughAndCold.asp

It is expected that all affected retail stock will include this warning by 1 May 2009 and will either be on the product label or as a sticker affixed to the product. The sticker is a temporary labelling compromise agreed between Medsafe and the New Zealand Self-Medication Industry Association.

Medsafe and the MARC are continuing to review the safety and efficacy of cough and cold products in children over two years of age, and are considering the risks and benefits of these products.