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Cough and cold remedies no longer recommended for children under six years

Most over-the-counter cough and cold medicines should no longer be used in children under six years, according to new advice issued by the Medicines and Healthcare products Regulatory Agency on 28 February 2009.

The advice is part of a package of measures recommended by the Commission on Human Medicines to promote the safer use of OTC cough and cold medicines for children under 12 years following a review of the benefits and risks of these medicines by the MHRA.

MHRA review of cough and cold medicines

The review found no evidence that OTC cough and cold medicines have any benefits for children under six years and that they can cause side effects such as allergic reactions, effects on sleep and hallucinations.

OTC cough and cold medicines no longer recommended for children under six years are:

  • Antitussives (dextromethorphan and pholcodine)
  • Expectorants (guaifenesin and ipecacuanha)
  • Nasal decongestants (ephedrine, oxymetazoline, phenylephrine, pseudoephedrine and xylometazoline)
  • Antihistamines (brompheniramine, chlorphenamine, diphenhydramine, doxylamine, promethazine and triprolidine)

For children aged six to 12 years OTC cough and cold medicines containing these ingredients will continue to be available but will only be sold in pharmacies, with clearer advice on the packaging.

The MHRA has stressed that there are no specific safety concerns with these medicines and that companies will be allowed to “sell through” their products.

Other measures include phasing out illogical combinations of ingredients such as cough suppressants and expectorants and ensuring that all cough and cold liquid products, including adult preparations, are in child-resistant containers.

Labelling changes

The pharmaceutical industry has agreed to make the necessary labelling changes to reflect the new advice and will introduce updated labelling and educational material regarding best treatment for coughs and colds in children.

Newly labelled products are expected to start to appear for the 2009 cough and cold season and the changes should be completed by March 2010.

The MHRA has said it will not ask pharmacists to remove medicines with old labelling because many of these products are used in adults and children, and withdrawing the products would cause a shortage. In addition, they say that withdrawing these medicines would not be proportionate to the risk of the side effects.

Products authorised for children aged six to 12 years classified as general sale list (GSL) will have their status changed to pharmacy (P) only medicine.

However, GSL products may continue to be sold on open shelves and remain available through other non-pharmacy settings until new packaging reflecting the P legal status becomes available.

The Society's reaction

Responding (PDF, 47K) to the guidance, David Pruce, director of policy and communications at the Royal Pharmaceutical Society, said the following can be recommended for children under six years who have uncomplicated coughs and colds:

  • Paracetamol or ibuprofen to relieve pain and lower temperature
  • Simple non-pharmacological cough mixtures for the treatment of coughs (eg, paediatric simple linctus or those containing glycerol or honey and lemon)
  • Vapour rubs and inhalant decongestants that can be applied to children's clothing to provide relief of stuffy or blocked nose for children and infants over three months
  • Saline (sodium chloride 0.9 per cent) nose drops — can be helpful particularly in infants who are having difficulty feeding

The Proprietary Association of Great Britain is arranging for leaflets containing information for parents on how to manage coughs and colds in children to be distributed to pharmacies.

Leak forces early release of the information

Asked why the MHRA issued the new advice to the national media at the weekend rather than informing the pharmacy profession of its intentions, a spokesman told The Journal that a leak had forced the MHRA to release the information and that it had not been the agency’s intention to release the information at that time.

He stressed that once the MHRA became aware of this it worked closely with pharmacy groups to give pharmacists, as well as the public, accurate, timely information.

Last year, the MHRA issued advice that children under two years should not be treated with OTC cough and cold medicines. However, the MHRA pointed out that its recent review did not identify the kind of safety issues unearthed at that time.

Citation: The Pharmaceutical Journal URI: 10244795

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