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The New England Journal of Medicine has published an article that gives an insight into recent concerns raised in the United States of America over the risk-benefit profile of children’s cough and cold medications.
The products discussed are widely available direct to the public and contain antihistamines, decongestants, antitussives, and expectorants for the relief of coughs and colds. Despite the huge range of products and sales of 95 million packs each year there is little evidence to support continued use. All six randomised placebo controlled trials conducted since 1985 have failed to show any meaningful difference in efficacy between active ingredients and placebo.
The Cochrane review of over-the-counter medications for acute cough in children and adults in ambulatory settings concludes:-
“There is no good evidence for or against the effectiveness of OTC medicines in acute cough. The results of this review have to be interpreted with caution due to differences in study designs, populations, interventions and outcomes between studies. The numbers of studies in each group were small, and studies often showed conflicting results. Effect sizes in many studies were unclear and it is questionable as to whether all of the positive results are clinically relevant.”
There is however evidence of harm with some 750,000 calls of concern related to cough and cold products made to poison centres since January 2000, and 1,500 visits to emergency rooms by children under two who had taken these products in 2004 and 2005. Finally, over the past few decades, the Food and Drug Administration (FDA) have identified 123 deaths related to the use of such products in children under six.
The article goes on to criticise the marketing and continued availability of these products and the lack of action taken by the FDA in light of the facts laid out above.
Action: Cough medicines have been widely bought over the counter and prescribed for generations. The balance of benefits and harms, certainly for children, seems to be shifting and all clinicians should re-evaluate their advice to patients and parents concerning these products.
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