Cough medicines for children

On 28th February 2009, The Commission of Human Medicines (CHM) reported on a previous review of the possible benefits and risks of over-the-counter (OTC) cough and cold remedies for children under 12 years old which was recently completed by the Medicines and Healthcare products Regulatory Agency (MHRA).

This report has lead to a radical change in the advice given to parents of children with coughs and colds affecting such areas as age ranges, child resistant packaging and new advice on labelling. The key points to come out of the report are:

  • Cough and cold remedies containing certain ingredients should no longer be used in children under 6 years old as the lack of robust evidence of their benefits is lacking.
  • Products for children from ages 6 to 12 years old will continue to be available in pharmacies. Medicines used to treat this group can be considered after trying basic principles of best care.
  • Some combinations of products in currently available products which are seen as illogical (cough suppressants + cough expectorants) will be phased out.
  • All liquid preparations containing medicines for cough and colds will be in a child resistant container.

Products affected

The OTC (non-prescription) cough and cold remedies containing the following ingredients are affected by the advice:

  • Antitussives – dextromethorphan and pholcodine
  • Expectorants – guaifenesin and ipecacuanha
  • Nasal decongestants – ephedrine, oxymetazoline, phenylephrine, pseudoephedrine and xylometazoline
  • Antihistamines – brompheniramine, chlorphenamine, diphenhydramine, doxylamine, promethazine and triprolidine

Single ingredient pain relief products for children are not affected by this announcement.

Background to the Change

As a parent, you will know that coughs and colds occur frequently in children. They are usually self-limiting and rarely harmful to the child even when left untreated. Coughs also have the physiological function of removing mucus secretions from the airways.

Whilst the combination products have not raised any particular concern about their safety, it is the case that many of the existing products have been in use for a long time and when introduced, the requirement to demonstrate safety and efficacy was less robust than now.

There is no current evidence that the products containing the above ingredients actually help. Given that there have been some reports of side effects with these ingredients, their risks outweigh ther benefits. For children over 6 years old, the risks are less since they have fewer incidences of cough and cold, they are bigger (somewhat obvious, but true nonetheless) and they can tell you if the medicine is working or not. For this group of children, the above products will continue to be available but only through a pharmacy.

Current advice on treating coughs and cold in children

It is hard to believe but it is quite normal for a child to have a cold or upper respiratory tract infection, eight or more times a year. The vast array of viral infections are infectious in children who have not had time to build immunity and thus get fewer colds. The current best advice is:

  • Since colds are caused by viruses and not bacteria, antibiotics do not help.
  • Most colds will improve within 5 to 7 days.
  • Cough and cold remedies have not shown to be effective and can cause side-effects in younger children. The risk of poisoning is a danger if your child accidently takes too much medicine.
  • Decongestants do not work effectively and can make the stuffiness worse. (Saline nose drops can help in infants)
  • An increase in fluid intake is helpful and should be encouraged.
  • A raised pillow can help babies breathe more easily.
  • Fever and pain can be treated with paracetamol and ibuprofen (alternate dosing) using the correct liquid preparations for your child’s age.
  • Wash your hands frequently (and the rest of the family) to reduce the spread of colds from infected secretions.

Children will also often cough when they have a cold. As long as they are eating and breathing normally without wheezing it is usually nothing to worry about. For more severe coughing see your GP. Also, if your child has chronic coughing worsened by exercise or worse at night, see your GP since it may be a sign of asthma. Any signs of trouble breathing should be referred immediately.

Plenty of warm, clear liquids should be given such as lemon and honey. Vapour rubs can be applied to childrens clothing to relieve a blocked nose.

Conclusions

Provided you have given the recommended dose of the above medicines to your child you do not need to worry. These changes will take place gradually over the next few months and any medicines that you have at home at present that are affected can be returned to your pharmacy for disposal.

The most common OTC medicines that will be unavailable for use in under 6 year old children include:

Veno’s Honey and Lemon
Veno’s Expectorant
Benilyn Childrens Range
Calcold
Calpol Night
Cofsed Linctus
Junior Meltus
Medised for Children
Actifed Multi-Action
Sudafed Childrens/Linctus/Expectorant
Otrivine Childrens Drops
Robitussin Chesty
Tixylix Cough and Cold/Chesty/Night
Vicks Cough Syrup for Dry Coughs
Vicks Cough for Chesty Coughs

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