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Prescribing information

Cough and cold products banned in children under the age of 6 years

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Medicines Management provides essential evidence-based information on medicines and prescribing for nurse prescribers and those involved in administering medicines

 

Children under six years of age should not use over-the-counter (OTC) cough and cold products, the Commission on Human Medicines (CHM) advised recently (MHRA, 2009). The CHM also suggested that measures to ensure that children aged 6–12 could safely use OTC cough and cold medicines, which will now be sold in pharmacies only. Pharmacists will offer updated advice and packaging will contain clearer information.

The changes follow a CHM review suggesting there ‘is no robust evidence’ that a number of ingredients in cough and cold products (Table 1) work in children. They can also occasionally cause side-effects, such as allergic reactions, sleep disturbances or hallucinations.

 

Table 1. Ingredients involved

Drug classExample
Nasal decongestantsPseudoephedrine
Ephedrine
Phenylephrine
Oxymetazoline
Xylometazoline
AntihistaminesDiphenhydramine
Chlorphenamine
Bromopheniramine
Promethazine
Triprolidine
Doxylamine
AntitussivesDextromethorphan
Pholcodine
ExpectorantsGuaifenesin
Ipecacuanha

 

When many of the products received authorisation, regulators approved the child’s dose based on studies in adults. However, growing evidence shows that children are not pharmacokinetically ‘small adults’ (Greener, 2008).

After a preliminary review, the CHM advised in 2008 that children aged under two years may be at particular risk from side-effects associated with cough and cold products, especially if given in overdose. A labelling change removed doses for these children.

However, body weight rather than age per se influences the risk of adverse events. The CHM notes that some children aged 2–6 may weigh the same as infants aged under two years. Therefore, after reviewing the available evidence, the CHM concluded that ‘the balance of risks and benefits is unfavourable in children under six’. It also recommended further research on the effectiveness of cough and cold products in children aged over six.

In the meantime, parents and carers can consider using cough and cold products in children aged 6–12 years after they have tried basic care (see Box). The CHM says older children are at less risk from adverse events as they suffer fewer coughs and colds, their biological development and size means they tolerate medicines better and they can let parents and carers know if the medicine works.

Over the coming months, manufacturers will phase in products with updated labelling, accompanied by educational material summarising the management of childhood coughs and colds. They will also phase out ‘illogical’ combinations such as cough suppressants and expectorants. The CHM aims to complete the change by March 2010. Meanwhile, nurses can suggest that parents follow Department of Health (2007) guidance.

Advice for parents

  • Advise parents who treated a child with a cough or cold products not to worry if they used the recommended dose. However, they should contact a health professional or NHS Direct if they are worried about the child’s condition.
  • Parents should check the medicines they have at home and take any that are unsuitable, out of date or no longer needed to a pharmacy for disposal.
  • Remind parents that viruses cause colds so antibiotics do not help. Reassure parents that most colds will resolve in 5–7 days. However, a cough with a temperature and/or breathlessness may indicate a bacterial chest infection. Children with these symptoms should see their GP.
  • Children should also see their GP if symptoms do not improve after five days, the condition worsens or immediately if they have trouble breathing.
  • Nasal decongestants can exacerbate stuffiness so treatment should last for a maximum of two to three days.
  • Saline nose drops can loosen dried nasal secretions or relieve a stuffy nose. Parents could try tickling the nose with a cotton bud to cause sneezing. Clearing the nose in these ways can be especially useful for children experiencing problems feeding.
  • Advise parents to increase the child’s fluid intake and ensure the child gets enough rest. Children aged over one year may benefit from a warm lemon and honey drink.
  • Paracetamol or ibuprofen can alleviate fever and pain but parents must use the correct dose.
  • Advise parents to take a child with chronic cough to see their GP. A persistent cough, especially if particularly troublesome at night or triggered by exercise, might be a sign of asthma.

 

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