12th March 2009
In the absence of robust evidence for their effectiveness, and the risk of harm, the MHRA has warned against the use of many commonly used over-the-counter cough and cold medicines for children under six years of age. Supply of these medicines for children aged 6–12 years is restricted to pharmacies.
Parents and carers should no longer give over-the-counter (OTC) cough and cold medicines containing certain ingredients (see below) to children less than six years of age. They should follow advice to relieve symptoms as outlined in the Department of Health’s 2007 guidance ‘Birth to Five’. For 6 to 12 year olds, these medicines will continue to be available but will only be sold in pharmacies, with clearer advice on the packaging.
Which medicines are affected?
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
- antihistamines: brompheniramine, chlorphenamine, diphenhydramine, doxylamine, promethazine and triprolidine.
A list of branded products affected are available on the MHRA website. These have details of:
- the products parents can still use to treat coughs and colds in children under 6 years of age (‘List 1’);
- the products which already only have dosages for children aged 6 years and over (‘List 2’); and
- the products which currently have doses for children aged under 6 and are changing their labelling to remove these doses. These can still be used to treat children over 6 years old (‘List 3’)
A list of combination products that will be phased out from the market for use in children under 12 years is also available on the MHRA website.
We have previously blogged the MHRA preliminary advice issued in March 2008 which stated that certain cough and cold medicines should not be used in children under 2 years. This followed similar earlier advice from the FDA in response to reports of serious adverse events, including death with these medicines, in children aged under 2 years (see blog). The present MHRA advice follows a thorough review of the benefits and risks of these medicines in children under the age of 12 years.
The MHRA review did not identify the safety issues of the kind which prompted their action in the under-2s in March 2008. However, the review found no robust evidence for their effectiveness but recognised that they can cause side effects, such as allergic reactions, effects on sleep or hallucinations.
The MHRA suggest that certain cough and cold medicines should not be used at all in children under the age of 6 years. They go on to advise that they should not be used first-line in children aged 6–12 years but, if they are, this should be for no more than five days. For children aged over 6 years, the MHRA considered that 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 will still be available for these older children, but only through pharmacies.
Although these medicines will still be available in their current packaging, they will eventually have strengthened warnings on labels, and all liquid cough and cold medicines (including those for adults) will be supplied in child resistant containers. The MHRA recognised that some combinations of ingredients are illogical (such as cough suppressants and expectorants) and medicines containing these combinations will be phased out.