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HealthInfo Canterbury

Over-the-counter cold medicines & children

In 2009, the MHRA (Medicines and Healthcare products Regulatory Agency) produced the following advice after extensive research into the use of cold medicines in children:

"The new advice is that parents and carers should no longer use over-the-counter (OTC) cough and cold medicines in children under 6. There is no evidence that they work, and can cause side effects, such as allergic reactions, effects on sleep or hallucinations.

"For 6- to 12-year-olds these medicines will continue to be available but will only be sold in pharmacies, with clearer advice on the packaging and from the pharmacist. This is because the risks of side effects are reduced in older children because they weigh more, get fewer colds and can say if the medicine is doing any good. More research is being done by industry on how well these medicines work in children aged 6 to 12 years."

This evidence was reviewed in New Zealand by the Medsafe Cough and Cold Review Group and they agreed with the findings. The group has recommended to Medsafe that oral cough and cold medicines containing the following substances should not be used in children under 6 years of age:

brompheniramine

chlorphenamine

dextromethorphan

diphenhydramine

doxylamine

guaifenesin

ipecacuanha

phenylephrine

pholcodine

promethazine

pseudoephedrine

triprolidine

Medsafe has accepted this recommendation and is working closely with the sponsors (pharmaceutical companies) to update the package labelling of the affected cough and cold medicines.

The Cough and Cold Review Group considered that the use of cough and cold medicines containing only bromhexine, or intra-nasal decongestants (such as oxymetazoline and xylometazoline) should remain restricted to adults and children 2 years of age and over.

Parents should also be aware that traditional vapour rubs to relieve congestion should not be used in babies under 2, as they can cause airway irritation and breathing distress. Always read the directions on any medication or speak to a pharmacist if you are not sure.

This link provides a summary of these recommendations.

Written by HealthInfo clinical advisers. Updated February 2015.

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Page reference: 59375

Review key: HICIC-150982