Over-the-counter cough and cold remedies — not for young children

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Key pointsChildren aged < 6 years should not be given OTC cough or cold medicines |
Limited evidence for use of these medicines in children aged < 6 years
| Why OTC cough and cold medicine are not recommended in children | Adverse events after use of OTC cough and cold medicine in children | References

Summary

The Therapeutic Goods Administration has recommended that children aged < 6 years should not be given over-the-counter (OTC) cough and cold medicines.

There is a lack of evidence for either efficacy or safety to support the continued use of OTC cough and cold medicines in this age group. The potential risks outweigh the limited benefits.

Older children, aged 6 to 11 years, should only be given OTC cough and cold medicines on the advice of a doctor, pharmacist or nurse practitioner. 

Key points

  • Children generally have 5–10 colds per year that are usually viral in origin, generally self-limiting and rarely harmful.
  • Most OTC cough and cold medicines have not been tested adequately in children aged < 6 years.There is no evidence for efficacy of OTC cough and cold medicines in children < 6 years.
  • The number and types of adverse events reported in children indicate that the risk of harm outweighs any benefit from the active ingredients commonly found in OTC cough and cold medicines.

Children aged < 6 years should not be given OTC cough or cold medicines

Labelling changes to OTC cough and cold medicines for winter 2013

The TGA has reviewed the safety and efficacy of OTC cough and cold medicines and recommended that children aged < 6 years should not be given these to treat cough and cold symptoms.1 Labelling and packaging changes will be introduced progressively from September 2012 so that by winter 2013 all affected products will carry a label warning and have child-resistant packaging. Some products may also include a warning regarding use in older children.1

The OTC cough or cold medicine ingredients reviewed by the TGA are listed in Table 1.

Similar recommendations are in place also in Canada, the UK and New Zealand.3–5 In the US, regulatory authorities have recommended that some OTC cough and cold medicines should not be used in children aged < 4 years.6

Table 1
OTC cough and cold medicine ingredients reviewed by the TGA1,2

Antihistamines

brompheniramine maleate, chlorpheniramine maleate, dexchlorpheniramine maleate, diphenhydramine hydrochloride, doxylamine succinate, pheniramine maleate, promethazine hydrochloride, triprolidine hydrochloride

Antitussives

codeine phosphate, dextromethorphan hydrobromide, dihydrocodeine tartrate, pentoxyverine citrate, pholcodine

Expectorants/mucolytics

ammonium chloride, bromhexine hydrochloride, guaifenesin (guaiphenesin), ipecacuanha, senega and ammonia

Decongestants

oxymetazoline hydrochloride, phenylephrine hydrochloride, pseudoephedrine hydrochloride, xylometazoline hydrochloride

Children aged < 6 years experience more coughs and colds than older age groups

Children experience 5–10 upper respiratory tract illnesses each year.7–9 As a result, parents of children in younger age groups are likely to be given OTC cough or cold medicines more frequently than older children. Therefore the potential for harm from these medicines is greater in this younger age group.

Children aged 6–11 years should only be given OTC cough or cold medicines on the advice of a doctor, pharmacist or nurse practitioner.1

Limited evidence for use of these medicines in children aged < 6 years

A Cochrane review assessing the effects of OTC medicines for acute cough in adults and children found that there was no good evidence for or against the effectiveness of these medicines in acute cough.10

A search of the literature since 1991 identified nine clinical trials that examined the efficacy or safety of various cough and cold medicines.11–18 Interpretation of the clinical trial results was limited by:

  • small numbers of participants meant the trials were not adequately powered to show a difference between the active substance and the comparator (or placebo)
  • selection bias because randomisation and allocation details were not included
  • symptoms were not regularly assessed throughout a 24-hour period
  • symptoms other than those related to the therapeutic effect were measured
  • outcome measures were not well defined and therefore not easily compared with other similar trials
  • concomitant use of other medicines (e.g. antibiotics) was permitted.

Seven trials (including one trial with two comparator arms) reported that OTC cough or cold medicines were no more effective than placebo, as follows:

  • antitussive–bronchodilator combinations (in one trial)13
  • antitussives (in three trials)13,17,19
  • antihistamines (in two trials)15,16
  • antihistamine decongestants (in two trials).11,12

Why OTC cough and cold medicine are not recommended in children

Children metabolise drugs differently to adults

Developmental changes in physiology and consequently in pharmacology influence the efficacy, toxicity and dosing regimens of medicines used in young children.20 Young children metabolise many drugs differently to adults due to their size and variable enterohepatic circulation, especially with repeated dosing.20

While rare, some young children may experience central nervous system stimulation (excitation, hallucinations, ataxia or seizures) rather than sedation after use of OTC cough and cold medicines that contain antihistamine.21

Aetiology and management of cough are different to those in adults

In adults and children most coughs are due to the common cold and may resolve spontaneously.22–24 However, some respiratory infections in children can be serious, especially those associated with respiratory syncytial virus (RSV) or Bordetella pertussis, and urgent laboratory confirmation may be indicated.

OTC cough and cold medicine ingredients may interact with concurrent medications

Anaphylactic and hypersensitivity reactions have been reported in all age groups after taking OTC cough and cold medicines.25 A number of these products contain multiple active ingredients, and severe interactions can occur between these and some other drugs.5

In addition, some OTC cough and cold medicines contain both a decongestant and an antitussive, which may counteract the activity of each other.26

Adverse events after use of OTC cough and cold medicine in children

The Medicines and Healthcare Products Regulatory Agency (UK) reported in 2008 that there had been adverse drug reaction reports in more than 360 children aged < 12 years after use of OTC cough and cold medicines.5 A review of poisons centre data after the voluntary withdrawal of OTC cough and cold medicines in 2007 in the US indicated that there was a significant decline in reported overdoses in children aged < 2 years.27 There was no decline in the 2–5 years age group, who were not targeted by the withdrawal.27

In Australia, the TGA Database of Adverse Event Notifications does not always specify age but there have been numerous reports of accidental overdoses with OTC cough and cold medicines in children notified between 2009 and 2012.25,28 Parental confusion over the packaging and dosing instructions with these products has further highlighted the need for the proposed TGA labelling and packaging changes.

References
  1. Therapeutic Goods Administration. OTC cough and cold medicines for children – final outcomes of TGA review. 15th August 2012.  Australian Government, 2012. http://www.tga.gov.au/industry/otc-notices-cough-cold-review-outcomes.htm (accessed 23 October 2012).
  2. Therapeutic Goods Administration. TGA internal panel report on the safety, efficacy and use of cough and cold medicines in the treatment of children aged 2-12 years.  Australian Government, 2009. http://www.tga.gov.au/pdf/archive/consult-labelling-cough-cold-091022-panel-report.pdf (accessed November 2012).
  3. Health Canada. Health Canada Releases Decision on the Labelling of Cough and Cold Products for Children. 2008. http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2008/2008_184-eng.php (accessed 23 October 2012).
  4. MEDSAFE New Zealand. Cough and cold medicines –- an update. 2011. http://www.medsafe.govt.nz/profs/PUArticles/CoughAndColdMedicines.htm (accessed 23 October 2012).
  5. MHRA United Kingdom. Overview – Risk:benefit of OTC cough and cold medicines in children. 2010. http://www.mhra.gov.uk/home/groups/pl-p/documents/websiteresources/con041374.pdf (accessed 23 October 2012).
  6. US Food and Drug Administration. FDA Statement Following CHPA's Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children. 2008. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116964.htm (accessed 23 October 2012).
  7. Leder K, Sinclair MI, Mitakakis TZ, et al. A community-based study of respiratory episodes in Melbourne, Australia. ANZJPH 2003;27:399–404. [PubMed]
  8. Mossad SB. Treatment of the common cold. BMJ 1998;317:33–6. [PubMed]
  9. Shann F. How often do children cough? Lancet 1996;348:699–700. [PubMed]
  10. Smith SM, Schroeder K, Fahey T. Over-the-counter (OTC) medications for acute cough in children and adults in ambulatory settings. Cochrane Database Syst Rev 2012;8:CD001831. [PubMed]
  11. Clemens CJ, Taylor JA, Almquist JR, et al. Is an antihistamine-decongestant combination effective in temporarily relieving symptoms of the common cold in preschool children? J Pediatr 1997;130:463–6. [PubMed]
  12. Hutton N, Wilson MH, Mellits ED, et al. Effectiveness of an antihistamine-decongestant combination for young children with the common cold: a randomized, controlled clinical trial. J Pediatr 1991;118:125–30. [PubMed]
  13. Korppi M, Laurikainen K, Pietikainen M, et al. Antitussives in the treatment of acute transient cough in children. Acta Paediatr Scand 1991;80:969–71. [PubMed]
  14. Paul IM, Beiler J, McMonagle A, et al. Effect of honey, dextromethorphan, and no treatment on nocturnal cough and sleep quality for coughing children and their parents. Arch Pediatr Adolesc Med 2007;161:1140–6. [PubMed]
  15. Paul IM, Yoder KE, Crowell KR, et al. Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for coughing children and their parents. Pediatrics 2004;114:e85–90. [PubMed]
  16. Sakchainanont B, Ruangkanchanasetr S, Chantarojanasiri T, et al. Effectiveness of antihistamines in common cold. J Med Assoc Thai 1990;73:96–101. [PubMed]
  17. Taylor JA, Novack AH, Almquist JR, et al. Efficacy of cough suppressants in children. J Pediatr 1993;122:799–802. [PubMed]
  18. Yoder KE, Shaffer ML, La Tournous SJ, et al. Child assessment of dextromethorphan, diphenhydramine, and placebo for nocturnal cough due to upper respiratory infection. Clin Pediatr (Phila) 2006;45:633–40. [PubMed]
  19. Paul IM, Shaffer ML, Yoder KE, et al. Dose-response relationship with increasing doses of dextromethorphan for children with cough. Clin Ther 2004;26:1508–14. [PubMed]
  20. World Health Organization. Promoting safety of medicines for children.  WHO press, 2007. http://www.who.int/medicines/publications/essentialmedicines/Promotion_safe_med_childrens.pdf (accessed 23 October 2012).
  21. Australian Medicines Handbook 2012 (online). Sedating antihistamines. Adelaide: Australian Medicines Handbook Pty Ltd, 2012. http://www.amh.net.au (accessed November 2012).
  22. Chang AB. Pediatric cough: children are not miniature adults. Lung 2010;188 Suppl 1:S33–40. [PubMed]
  23. Chang AB, Berkowitz RG. Cough in the pediatric population. Otolaryngol Clin North Am 2010;43:181–98, xii.  [PubMed]
  24. Goldsobel AB, Chipps BE. Cough in the pediatric population. J Pediatr 2010;156:352–8. [PubMed]
  25. Therapeutic Goods Administration Department of Health and Ageing. Database of Adverse Event Notifications. 2011. Available at: http://www.tga.gov.au/daen/daen-entry.aspx  (accessed 23 October 2012).
  26. Australian Medicines Handbook 2012 (online). Cough. Adelaide: Australian Medicines Handbook Pty Ltd, 2012. http://www.amh.net.au (accessed November 2012).
  27. Klein-Schwartz W, Sorkin JD, Doyon S. Impact of the voluntary withdrawal of over-the-counter cough and cold medications on pediatric ingestions reported to poison centers. Pharmacoepidemiol Drug Saf 2010;19:819–24. [PubMed]
  28. Isbister GK, Prior F, Kilham HA. Restricting cough and cold medicines in children. J Paediatr Child Health 2012;48:91–8. [PubMed]