Article date: April 2009
The Commission on Human Medicines (CHM) has advised on measures to improve the safe use of cough and cold medicines for children under 12 years. This follows a thorough review by the MHRA of the benefits and possible risks of over-the-counter (OTC) cough and cold medicines for children under 12 years.
OTC cough and cold medicines containing the following active ingredients are affected by the advice: antitussives (dextromethorphan and pholcodine); expectorants (guaifenesin and ipecacuanha); nasal decongestants (ephedrine, oxymetazoline, phenylephrine, pseudoephedrine, and xylometazoline); and antihistamines (brompheniramine, chlorphenamine, diphenhydramine, doxylamine, promethazine, and triprolidine).
Overall these measures include changes to age ranges, introduces new advice on labelling, introduces child-resistant packaging (to help prevent overdoses), and recommends research into how effective the medicines are in children over six years.
Colds and coughs occur frequently in children but they are self-limiting and rarely harmful if left untreated. Moreover, many medicines given to children have not been properly studied in this population. Specific paediatric studies are needed because of differences between adults and children in drug handling or drug effects, which may lead to different dose requirements.
OTC cold and cough remedies 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.
Cough and cold remedies containing the above ingredients should no longer be used in children under 6 years as the balance of benefits and risk has not been shown to be favourable.
Products for children from 6 to 12 years will continue to be available in pharmacies where advice can be given.
Medicines to treat cough and colds in older children (6 to 12 years) can be considered supplementary to basic principles of best care.
Some combinations (such as cough suppressants and expectorants) are being phased out while all liquid products containing these ingredients will be in a child resistant container in future.
Newly packaged products reflecting the above advice will start to be introduced to pharmacies later this year in time for the 2009/10 winter cough and cold season. In the meantime medicines with the older labelling will continue to be available and can be supplied for use by older children and adults. Immediate withdrawal of products with older labelling is not necessary because of the absence of a safety issue.
Products currently authorised with General Sales List (GSL) legal status may continue to be sold on open shelves and remain available through other retail outlets, such as supermarkets, until the new packaging reflecting Pharmacy (P) legal status becomes available. We expect the change to be complete by March 2010.
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, the risk of toxicity is lower; 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 where advice can be given.
More research is required on how effective these products are in children over six years
Helpful advice for parents and carers on the basic principles of best care for children of all ages with coughs and colds can be found in the Department of Health’s book “Birth to 5”. Key aspects of this advice will be reflected in new Patient Information Leaflets accompanying all licensed products containing the active substances included in the review.
For more information see the medicines for children section of our website
See the regulation of children’s medicines drug safety update January 2009.
See the safety messages for medicines section of our website for further information for healthcare professionals
Article citation: Drug Safety Update April 2009, vol 2 issue 9: 8.