Children's cough and cold medicines: advice for parents
Publication Date:21/01/2008
Introduction
Parents and other carers have been reminded to be careful how they use cough and cold medicines in children. Always follow the instructions with care, never exceed the maximum recommended dose and use only in the age groups specified on the packaging, say UK drug safety experts.
What do we know already?
There are lots of cough and cold medicines for children that you can buy over the counter (OTC) from pharmacies without a prescription. They can contain a number of different ingredients that are designed to help the different symptoms you can get with a cold.
The Medicines and Healthcare products Regulatory Agency (MHRA) is the government body that checks the effectiveness and safety of drugs in the UK. It has issued the latest advice on using cough and cold medicines in children after the drug safety body in the US warned that these medicines should not be used in babies and children under the age of two years. The US drug safety body is called the Food and Drug Administration (FDA).
Why has the FDA warned against using cough and cold medicines in children under two?
US drug experts have advised parents not to use cough and cold medicines in babies and children under two years because of the side effects that may occur in this age group. Although these are rare they can be serious, even fatal. The FDA says they include convulsions, rapid heart rates and reduced consciousness.
In the UK, drug safety experts point out that the medicines used in the US are often stronger than those in the UK. Also, medicines in the US used to come with droppers. It's very difficult to tell how much medicine you are giving a child when you use one of these. Droppers are now banned in the US for children under two.
The FDA looked at cough and cold medicines that contain the following ingredients:
- Decongestants, which are designed to unclog a blocked nose. Examples include ephedrine, phenylephrine and pseudoephedrine.
- Cough suppressants, which aim to reduce coughing. One example is dextromethorphan.
- Cough expectorants, which aim to help you cough up mucus. One example is guaifenesin.
- Antihistamines, which aim to reduce sneezing and a runny nose. One example is diphenhydramine.
The FDA is currently looking at the safety of cough and cold medicines in children aged 2 to 11.
What does the MHRA say?
The MHRA says that parents and other carers should follow the instructions on using cough and cold medicines carefully. Read these thoroughly and always stick to the dose that’s recommended for your child’s age. If you have two or more children don’t assume both will need the same dose, check the packaging for the dose recommended for each child.
Some products contain more than one ingredient and these are listed on the packaging. If you are giving your child more than one medicine you need to make sure that these do not contain the same active ingredient, otherwise you might exceed the recommended dose.
The MHRA says that new laws have been made in the UK and European Union to improve the safety of medicines for children. It says that drug experts are currently reviewing some children’s cough and cold medicines, such as those for helping with a blocked nose, to see if the benefits of these products outweigh the risks.
What does this mean for me?
OTC cough and cold medicines are commonly used in children. And there have been relatively few reports of harmful effects happening because of them. But side effects can and do happen. For this reason it's important to take care when giving cough and cold medicines to children.
Bear in mind that there is no cure for the common cold. There is some evidence that some ingredients in cold medicines may help with symptoms in the short term, although little research has been done in very young children.
What should I do now?
Most colds and coughs clear up on their own within a few days. In the meantime, you should make sure your child drinks plenty of fluids, and if they have a fever, they may need a mild painkiller such as paracetamol or ibuprofen. Make sure you stick to the recommended dose of painkiller. Some cold medicines also contain painkillers, so be sure to read the labels of all the medicines your child is taking. Aspirin is not recommended for children under 16 because it can cause a dangerous condition called Reye's syndrome.
You may also wish to try non-drug treatments such as saline nasal drops or a humidifier. Ask your pharmacist about these treatments.
If you decide to use cough and cold medicines in children:
- Follow the directions on the packaging carefully. These will tell you how much medicine to give your child and how often to give it.
- Be very careful if you give your child more one medicine at a time. Many cough and cold medicines available over the counter contain more than one "active ingredient". If you use two medicines that have the same or a similar active ingredient your child could exceed the recommended dose.
- Use measuring spoons designed to be used for medicines. These usually come in the pack. Some household spoons may be bigger than those designed for measuring medicines and your child may get a bigger dose than is recommended.
- Choose medicines with childproof caps and keep these out of reach of children.
If you have any questions about using these medicines in children then speak to your pharmacist or doctor. Always call a doctor if you are worried about your child’s symptoms.
From:
U.S. Food and Drug Administration. FDA Releases Recommendations Regarding Use of Over-the-Counter Cough and Cold Products. 17 January 2008. Available at http://www.fda.gov/bbs/topics/NEWS/2008/NEW01778.html.
To find out more, see our information on the common cold.
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© BMJ Publishing Group Limited ("BMJ Group") 2007. All rights reserved
This information does not replace medical advice. If you are concerned you might have a medical problem please ask your Boots pharmacy team in your local Boots store, or see your doctor.




