New guidlines on medicines suitable for children published

The Medicines and Healthcare products Regulatory Agency (part of the UK government's Department of Health) has published new guidelines covering the use of Over The Counter (OTC) medicines for treating colds, coughs and other ailments in children under 6.

Should I be worried?

The main answer is no. There is no need to panic, even if you have recently given any of these medicines to your child, or have them in your house. The main message is that these medicines do not have enough evidence to show that they are effective in treating symptoms in small children.

These medicines will NOT be withdrawn or cleared from shelves. Instead the packaging and information provided to pharmacists will change.

What are the new guidelines?

The new guidelines state that certain ingredients used in medicines for children under 6 do not have the evidence to support their use in these cases and therefore should not be marketed as such. For affected medicines the usage instructions for children under 6 will be removed.

Which medicines are affected?

These guidelines cover medicines used to treat colds and coughs in under 6s which are available without prescription.

Are these medicines dangerous?

No, and they will still be available for treating symptoms in children over 6. There have been reports of adverse reactions to these medicines in some children in rare cases(hallucinations, loss of sleep).

Why have the guidelines been changed?

When these ingredients were first introduced, there was no widespread testing of their effects on young children, as this was considered unethical. Instead they were tested on adults. However it is now clear that smaller children do not react to these ingredients like scaled down adults, and some rare side effects have been reported. Because these medicines do not cure the cold or cough, but just help relieve the symptoms, it is now considered that the benefits do not justify the risks in this case.

What can I do if my child has a temperature?

For children over 6 you can proceed as before. For children under 6 you can use products containing paracetamol or ibuprofen, such as Calpol, Disprol, Medinol or Nurofen for Children.

Where can I get more information?

A full list of medicines suitable for use, and those which will no longer be marketed to children under 6, is available here: MHRA list of affected medicines.

This article was published on Mon 2 March 2009