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Medicines and Healthcare products Regulatory Agency
Updated advice: Over–the–counter cough and cold medicines for young children
Parents and carers are being advised that children suffering from a cough or cold should be treated with paracetamol or ibuprofen to lower the child’s temperature and if they have a cough to use a simple cough syrup [such as glycerol, honey or lemon]. For young babies, who are having difficulty feeding, nasal saline drops are recommended to help thin and clear nasal secretions. Vapour rubs and inhalant decongestants, which can be applied to a child’s clothing, can also be used to provide relief from a stuffy nose. The Commission on Human Medicines [CHM] has reviewed over–the–counter [OTC] products used for treating cough and colds in children, and has advised that certain medicines should no longer be used in children under the age of two. Professor Rosalind Smyth, chair of the CHM Paediatric Medicines Expert Advisory Group said: “Coughs and colds are generally self–limiting conditions which will get better themselves usually within a few days. The management of symptoms in the under two's is best achieved with treatment to control fever [ibuprofen or paracetamol], together with simple cough mixtures.” The pharmaceutical industry has voluntarily agreed to change the labels on products to remove the dosage instructions for children under two, and to add additional instructions in relation to children aged two–six years, in keeping with the new advice. All affected products are currently being changed. Products with the updated advice on their packaging, and in the Patient Information Leaflets, will be in pharmacies and stores by October 2008. A leaflet for patients/carers will be available for additional advice. For older children, cough and cold medicines will continue to be available to help treat symptoms. If you are concerned about your child’s condition, or about the correct medicine to use, then you should speak to your pharmacist, health visitor, or other healthcare professional. Additional information
The CHM took account of experience in the United States where a safety review of children’s cough and cold medicines revealed a number of serious reports. The vast majority of these reports involved children under two years, and in many cases children had been given too much medicine because parents /caregivers had been confused about the correct dose or had given more than one product containing the same active ingredient. As a result, the Food and Drug Administration recently announced that OTC cough and cold preparations should no longer be used in children under two years. In the UK there have been far fewer reports, but the data does suggest that children under two are at greater risk of any potential harm. This is because children under two are more vulnerable due to their small size and therefore may be particularly susceptible to the effects of overdose. This new advice will reduce that possibility and is a precautionary measure. Some products already comply with the new advice but to change all the labels on all the products which are affected is a massive exercise. Many of the remedies which are affected by this new advice are also used for older children and carry dosage instructions for children over two. Some of them are products intended for adults which also have dosage instructions for infants although this is not their main use. It is essential that it is done in a way that ensures that the medicines remain available for use by the rest of the population.
The majority of products currently authorised for children under six can remain on the market and be sold as before. Some of these products will be re–labelled to include updated advice. These products may also be authorised for older children and adults. 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. However, these products can still be sold over the pharmacy counter for older children. We have asked that these products be removed from general sale, until they have been repackaged with new dosage instructions and updated advice. They will still be available under the supervision of a pharmacist, for children over the age of two.
The cough and cold medicines which will no longer be licensed for children under the age of two, contain the ingredients:
Infolink: Medicines and Healthcare products Regulatory Agency, Central enquiry point, Information Centre, 10–2 Market Towers, 1 Nine Elms Lane, London SW8 5NQ. Telephone: 020 7084 2000 [weekdays] 020 7210 3000 [other times]. Email: info@mhra.gsi.gov.uk. Website: www.mhra.gov.uk.
The MHRA is an executive agency of the Department of Health. The MHRA is responsible for ensuring that medicines and medical devices work and are acceptably safe. From your browser | Email the page | Email the page link | Print the page | Add page to favourites Handy guide to wellbeing series | For you, family and friends
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