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Cough and Cold Remedies for Children – CHM and MHRA Advice

The Commission on Human Medicines (CHM) has just released advice following a comprehensive review that was conducted by the Medicines and Healthcare products Regulatory Agency (the UK’s equivalent to the FDA) on Cough and Cold Remedies for Children.

The review was conducted to assess the benefits and potential risks of over-the-counter (OTC) cough and cold remedies that are currently available on the market for children aged 12 and under.

The MHRA assessed the following ingredients in OTC medications:

Antitussives (cough suppressants): dextromethorphan and pholcodine
Expectorants (for productive coughs): guaifenesin and ipecacuanha
Nasal decongestants: ephedrine, oxymetazoline, phenylephrine, pseudoephedrine and xylometazoline
Antihistamines: brompheniramine, chlorphenamine, diphenhydramine, doxylamine, promethazine and triprolidine

They concluded that:

There is no robust evidence that cold and cough medicines containing the above ingredients work. Given that there have been some reports of harm with these ingredients, the risks of cough and cold medicines containing them outweigh the benefits;

For children aged over 6 years, the risk from these ingredients is reduced because: they suffer from cough and cold less frequently and consequently require medicines less often; with increased age and size, they tolerate the medicines better; and they can say if the medicine is working. For these reasons cold and cough medicines containing the above ingredients can continue to be available for these older children, but only through pharmacies;

Further research is required on how effective these products are in children over 6 years.

The upshot:

Don’t panic! As you’ll have read, they are still available and will remain indicated for children 6 and over (albeit more stringently). It’s simply a review to weed out unnecessary, and to be quite honest, questionable medications that appear to offer little benefit when weighed up against the potential risks to children under 6. In some cases, they have been known to cause side effects such as allergic reactions, effects on sleep and hallucinations.

Why have they decided to wait until now?

The MHRA is working hard to improve the availability of high-quality, ethically researched and properly authorised medicines for children.

OTC cold and cough remedies, which have been in use for a very long time, were introduced when the requirement to demonstrate safety and efficacy was less robust compared to today’s standards. However, over the years, the products have raised no special concern about safety.

What should I do?

Always consult your General Practioner/Doctor if you are concerned about the health of your child. But remember, when kids catch coughs and colds, most of the time all you need to do is follow the time old premise that nature will sort itself out!

We usually stick to Calpol/Calprofen (paracetamol/ibuprofen for kids) to manage the headaches/sore throats/temperature and let nature take its course with the rest. Just make sure you follow the guide on the packet.

Here is the full MHRA Review on Cough and Cold Remedies for Children.

For the latest advice on all aspects of child health, immunisation, healthy eating, childhood illnesses and child safety, the Department of Health have produced an easy-to-use practical guide for parents called Birth to Five.

Category: Medicines

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