Published: November 2009

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Cough and cold medicines - further contraindication recommended

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Prescriber Update 30(4): 26
November 2009

Medsafe recently convened the Cough and Cold Review Group (CCRG) to review the benefits and risks of using cough and cold medicines in children. The CCRG consisted of representatives from CARM, the MARC, the New Zealand College of Pharmacists, the Royal New Zealand College of General Practitioners, the Paediatric Society of New Zealand, the Pharmaceutical Society of New Zealand, the pharmaceutical industry, Plunket and the public.

After considering all available safety and efficacy data, the CCRG considers the risk-benefit balance of these medicines to be unfavourable in children under six years of age. The CCRG has therefore recommended that cough and cold medicines be contraindicated for use in children under six years of age.

This recommendation applies to all medicines indicated for the treatment of the symptoms of the common cold that contain one or more of the following substances: brompheniramine, chlorphenamine, dextromethorphan, diphenhydramine, doxylamine, guaifenesin, ipecacuanha, phenylephrine, pholcodine, promethazine, pseudoephedrine, and triprolidine.

The CCRG considered that cough and cold medicines containing bromhexine alone, or intra-nasal decongestants (such as oxymetazoline and xylometazoline) should remain available to adults and children over two years of age.

This recommendation is due to there being less evidence of harm with these medicines.

Medsafe has accepted the advice of the CCRG and will work closely with the pharmaceutical industry to implement the recommendations as soon as possible. Medsafe has decided not to recall these medicines to ensure stock remains available for adults.

Medsafe will advise healthcare professionals when the contraindication comes into effect, at which point the affected cough and cold medicines must not be used in children under six years of age. In the meantime healthcare professionals are encouraged to familiarise themselves with the risk-benefit information available on the Medsafe website to understand the reasons for the CCRG recommendation.

Further information on the recommendations made by the CCRG, including the minutes of the Group’s meetings and a list of the affected medicines, can be found at: www.medsafe.govt.nz/hot/alerts/CoughandCold/CoughandCold.asp