Press release: Updated advice - Over-the-counter cough and cold medicines for young children

Press release

Date:	27 Mar 2008
Time:	09:00
Subject:	OTC cough and cold medicines in children
Contact:	Press Office 020 7084 3535/3564 or press.office@mhra.gsi.gov.uk Out-of-hours 07770 446 189

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 2s 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 2, and to add additional instructions in relation to children aged 2-6 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.

Notes to Editor

1. Coughs and colds in young children and babies can be unpleasant and upsetting both for the child and for parents/carers. However, these are self limiting conditions which will get better themselves within 2-3 days. Medicines intended to treat the symptoms will not cure the illness or shorten the length of the illness.
2. 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 2 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 2 years.
3. In the UK there have been far fewer reports, but the data does suggest that children under 2 are at greater risk of any potential harm. This is because children under 2 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.
4. 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 2. 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.
5. The instructions on the medicine about suitable age groups and appropriate doses should be followed carefully. Cough and cold medicines may contain more than one active ingredient and different brands may contain the same active ingredients. These are listed on the medicine packaging. Parents should not give a child more than one cough and cold medicine, as they may contain the same active ingredient(s) and the maximum recommended dose(s) for the drug(s) may be exceeded. The medicine should be administered carefully using the spoon or measuring device supplied to ensure the child does not receive more than the maximum dose.
6. The cough and cold medicines which will no longer be licensed for children under the age of 2, contain the ingredients:

The following products directly targeted at children under 2 should be removed from open shelves:

- these medicines can still be supplied under the supervision of a pharmacist for older children.