UK Introduces Tougher Restrictions On Cough And Cold Medicines For Children

Following a move in March 2008 to restrict the sales of certain cough and cold medicines [1] for children under the age of two, the UK Medicines and Healthcare products Regulatory Agency (MHRA) have now introduced further restrictions up to the age of six. These changes highlight the unproven benefits and certain risks associated with improper use of some of over-the-counter cough and cold medicines. The changes are only effective in the UK.

The affected ingredients are:

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

In response to the MHRA move, the Irish Medicines Board (IMB) released a statement saying that they are satisfied with current restrictions in place in the Irish market, which has always been more restrictive than the UK market.

The review covered all cough and cold treatments for children under the age of 12. It gave no cause for alarm if parents are currently using or have used these products in the past. All affected products will continue to be sold until current supplies are exhausted and new packaging becomes available (expected in the 2009/10 winter cough and cold season). To withdraw these medications immediately would cause a shortage and would be disproportionate considering the risk of side effects. The move is simply aimed at balancing the risks and benefits of these medicines.

The report did not specify safety concerns in same way that the previous review for under 2-years-olds did, however it did show that these over-the-counter cough and cold medicines do not necessarily work, and can be the cause of side effects including allergic reactions, disturbed sleep or hallucinations. The new guidelines advice against the use of medicines containing the affected ingredients in children under six. For these children guidance should be taken from the Department of Health booklet "Birth to Five" [2].

For children age 6 to 12, these medicines will continue to be available, but only from pharmacies, where professional advice is available and with updated dosage instructions on the packaging. Even in these older children, the use should be limited to a maximum of 5 days. The risk of side effects in this age group is decreased because of factors like bigger weight, better general health, and the ability to better describe how the medication if affecting them. The manufacturers are now carrying out further research into the effectiveness of these medicines.

Dr June Raine, the MHRA Director of Vigilance and Risk Management of Medicines, says: “Coughs and colds can be distressing for both you and your child but they will get better by themselves within a few days. Using simple measures to ease symptoms is likely to be most effective.”

She went on to say: “Over-the-counter medicines used to treat coughs and colds have been used for many years. However they came into use when clinical trials were not required to demonstrate that they worked in children. This means they were not specially designed for children. It is not right to assume safety and efficacy based on children being ‘small adults’. Children should have access to medicines that are acceptably safe and designed for their use.”

Young children are still developing their immunity so it's perfectly normal for them to get eight or more colds a year. As they build up their immunity they will get fewer colds. In most cases colds get better on their own and only require that you keep the child comfortable until they pass. Because they're caused by viruses antibiotics do not help.

• If a child develops fever you can use paracetamol if over 2 months and/or ibuprofen if over 3 months old to bring it down. Increased fluid intake is also recommended.
• Cough and sneezing are normal reactions to irritation and blockage in the airways and serve to clear catarrh, phlegm and mucus, so it's best not to suppress them. Simple herbal or glycerine cough mixtures will help with dry cough and warm clear liquids will help to break up the mucus.
• Saline drops, vapour rubs and inhalant decongestants can be used to relieve stuffed noses.
• To prevent overdosing avoid using more than one cough and cold medicine at the same time!
• If you're unsure about anything your pharmacist will help you decide what to do and refer you to a doctor if necessary.

L.W., L.G.