The Pharmaceutical Journal
Vol 280 No 7496 p393
5 April 2008

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What to advise for coughs and colds

The Medicines and Healthcare products Regulatory Agency announced last week that certain cough and cold medicines are no longer suitable for children under the age of two years. Matthew Wright (on the staff of The Journal) explains the agency’s rationale and puts to rest some misconceptions surrounding the change

On the basis of available evidence, the balance of risks and benefits associated with the use of most cough and cold medicines for children younger than two years is no longer favourable, the Medicines and Healthcare products Regulatory Agency has declared (see p419).

UK pharmacists used to providing these medicines to parents and carers of infants will no doubt be thinking about how to say “no” to such requests. The MHRA is recommending instead that parents use simple mixtures containing glycerol, honey or lemon for coughs, and vapour rubs, inhalant decongestants or saline drops for messy noses.

The MHRA’s Paediatric Medicines Expert Advisory Group and the Commission on Human Medicines recently assessed the safety of cough and cold medicines for children, following a review by the US Food and Drug Administration.

In an article in April’s Drug Safety Update — released early by the MHRA last week — Rosalind Smyth, chairman of the Paediatric Medicines Expert Advisory Group, says:

“The commission noted that although UK data do not raise the same level of concern as those for the US, five reports of deaths (the first in 1981) associated with use of cough and cold medicines in children younger than two years have been received via the yellow card scheme.

Moreover, the commission noted a lack of robust evidence for the efficacy of these medicines in children. It was noted that medication does not affect the course of the illness: it can only provide, at best, symptomatic relief.”

As stated in last week’s Journal (PJ, 29 March 2008, p353), the MHRA has stipulated that non-prescription cough and cold medicines containing the following active ingredients should not be used in children under two years old:

• Antihistamines — brompheniramine, chlorphenamine and diphenhydramine

• Cough expectorants — guaifenesin and ipecacuanha

• Cough suppressants — dextromethorphan and pholcodine

• Decongestants — phenylephrine, pseudoephedrine, ephedrine, oxymetazoline and xylometazoline

Because most non-prescription cough and cold products contain multiple drug ingredients it is crucial that parents and carers are made aware of the potential dangers of using more than one product. Accordingly, products which contain these ingredients and are licensed for use in children between the ages of two and six years will now need to carry more information:

• Details of maximum daily dose
• Warnings not to use with other cough and cold medicines
• Instructions to seek the advice of a pharmacist or other healthcare professional before use

Professor Smyth acknowledges that children’s cough and cold medicines often come with age-appropriate dose advice and that many are sold under the supervision of a pharmacist.

“However,” she points out, “parents and carers may be unaware of the risk of overdose that results from the simultaneous use of different products that may duplicate ingredients. The small body size of children younger than two years increases the risk of serious adverse events from such dosing errors.”

Confusion

The MHRA attempted to inform pharmacists — as well as The Journal — last week ahead of announcing the changes to the popular press. Unfortunately, a spokeswoman for the MHRA explained, the media found out ahead of the agency’s official statement, erroneously spreading the word that certain paediatric cough and cold products had been banned.

The MHRA was quick to issue a clarification on the matter. “The majority of products currently authorised for children under six can remain on the market and be sold as before.” it said. “Some of these products will be relabelled to include updated advice. Where the product indications include children under two years, our advice is that the product should no longer be used in this age group but can still be used for older children.

“We have requested that a small number of products which are particularly targeted at children under two, although also authorised for older children, are removed from open shelves.”

The National Pharmacy Association has also issued advice — available from the members section of its website. It says: “Cough and cold products targeted at children under the age of two which are licensed as GSL medicines should be removed from open display. You may continue to sell these products as P medicines, subject to the [MHRA] guidance.”

The following GSL products are currently affected:

• Asda Children’s Chesty Cough Syrup
• Bell’s Children’s Chesty Cough
• Boots Chesty Cough Syrup 1 Year Plus
• Boots Sore Throat and Cough Linctus 1 Year Plus
• Buttercup Infant Cough Syrup
• Calcough Chesty

The Proprietary Association of Great Britain said in a statement that these six products were highlighted “because of their name, pictures of babies on the pack or a clear indication of use for under-2s” and are being moved behind the counter “so pharmacists can check that people who are buying them are going to use them for older children”.

Sheila Kelly, PAGB executive director, confirmed: “There is a lot of misunderstanding about what is happening with children’s cough and cold medicines in the UK. Products are not being withdrawn. The industry will be voluntarily removing the doses for children under two years from the labels of many cold and cough remedies.”