Gordons Chemists issue the following advice on over-the-counter Cough & Cold medicines for young children:
GORDONS Chemists issue the following advice to concerned parents/guardians, regarding recent news stories relating to cold and cough medicines for children under two years of age.
Why the Change in Cough & Cold Medication for Young Children?
Following a review of the data on the safety and efficacy of cough and cold medicines in children, the Medicines and Healthcare Regulatory Agency (MHRA) has issued new advice and restrictions on the use of cough and cold remedies in young children.
“The key here is not to panic,” urges Helena Buchanan, Head of Health Promotions at Gordons Chemists.
“There are still a number of products available from your pharmacy to treat your children’s colds and coughs. Paracetamol or ibuprofen can still be used to lower the child’s temperature; and if your child has a cough a simple cough syrup (such as Simple Lintus, Glycerol, or Honey and Lemon) can be used. Vapour rubs and inhalant decongestants, which can be applied to a child’s clothing, can also be used to provide relief from a stuffy nose. For young babies, saline nasal drops are recommended to help thin and clear nasal secretions.
“If you have any concerns regarding Cough & Cold Medication for young children, our advice is that you contact your local pharmacist” (click to see a list of where you can find Gordons Chemists pharmacies).
Professor Rosalind Smyth, Chair of the Commission on Human Medicines (CHM) Paediatric Medicines Expert Advisory Group said: “Coughs and colds are generally self limiting conditions which will get better themselves, usually within a few days. The management of symptoms in the under 2s is best achieved with treatment to control fever (ibuprofen or paracetamol), together with simple cough mixtures.”
“The key is to consultant your pharmacist before giving medicines to your children,” says Helena. “Beyond this it is vitally important to follow the product’s own instructions which will give you the maximum daily dose information, and not to use the product with any other cough and cold medicines.”
Gordons Chemists Advice: Some Frequently Asked Questions regarding Cough & Cold Medication for Young Children.
I have several different Children’s Cough & Cold medicines at home – what should I do with these?
Gordons Chemists recommend that these products, if they contain any of the ingredients listed below, should not be used to treat children under the age of 2.
However, we would reassure you that the products are safe - if used at the correct dose - for older children or adults. Please note that the best available evidence may indicate that these products are no better than placebo (a placebo is a tablet or medication with no active ingredient).
We also advise that any unwanted medicines can be returned to your local pharmacy for disposal.
Will there be any long term harm for babies and young children who have used the restricted cough and cold remedies in the past?
We would reassure you that the Children’s Cough & Cold medicines which are no longer recommended, but have been used in the past, will not have caused harm to your children.
The change in the regulations has occurred because of a review of existing information. This review has indicated two things:
(1) that these products may not be beneficial
(2) that in some circumstances (usually overdose, misuse, or where there is an interaction with another medicine) harm can be caused.
Are products safe in children over 2 years?
For children older than 2 years, cough and cold medicines are considered safe at the recommended doses. Gordons Chemists strongly recommend that all dosage information, and any advice provided by your doctor or pharmacist, be followed carefully and not exceeded.
We also advise that a child should not be given more than one cough and cold medicine (unless otherwise advised to do so by your doctor or pharmacist) because different brands may contain the same active ingredient(s) or may interact with each other.
Why the change in Cough & Cold Medication for young children?
Following a review of the data on the safety and efficacy of cough and cold medicines in children, the Medicines and Healthcare Regulatory Agency (MHRA) has issued new advice and restrictions on the use of cough and cold remedies in young children.
This new advice is based on the best available evidence from the UK, and includes data from a recent Food and Drug Administration (FDA) review in the USA.
A study published in the New England Journal of Medicine concluded that the risks involved were from accidental overdose, deliberate misuse, or interactions with other medicines. Children under 2 years old can be particularly sensitive to overdose because of their small size, and different pharmacokinetics (what the body does to a drug) and pharmacodynamics (the effect of drugs on the body).
The pharmaceutical industry has voluntarily agreed to change the labels on affected products - to remove the dosage instructions for children under 2, and to add additional instructions in relation to children aged 2-6 years - in keeping with the new advice. All affected products are currently being changed. Products with the updated advice on their packaging, and in the Patient Information Leaflets, will be in pharmacies and stores by October 2008. A leaflet for patients/carers will be available for additional advice.
For older children, cough and cold medicines will continue to be available to help treat symptoms.
Which products are affected?
To date, it has not been possible to produce a comprehensive list of affected product.
Cough & Cold medicines which will no longer be licensed for children under the age of 2 contain the following ingredients:
- brompheniramine, chlorphenamine & diphenhydramine (anti-histamines);
- dextromethorphan and pholcodine (anti-tussives);
- guaifenesin and ipecacuanha (expectorants);
- phenylephrine, pseudoephedrine, ephedrine, oxymetazoline and xylometazoline (decongestants);
The MHRA will use a number of tests to determine which products are affected.
What Cough & Cold Medication is suitable for children between the ages of 2-6?
The good practice guidance applies to all children of all ages (subject to licensed indications), including those older than 2 years of age. However, cough and cold products containing the ingredients listed above can still be sold for children in this age group, and are believed to be safe when used at the recommended dosage.
However, Gordons Chemists are aware that the MHRA is continuing to review the recommendations for cold and cough products in children over 2 yrs, with findings to be published in the future.
CHANGES IN PRODUCTS FOR SALE, FOR CHILDREN OVER 2 YEARS
Products which contain the ingredients listed, and are licensed for use in children between the ages of 2 and 6 will need to carry the following extra information:
- Maximum daily dose information;
- Warning not to use with other cough and cold medicines;
- A warning to seek the advice of a pharmacist or other healthcare professional before use.