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 between active ingredients and placebo.
There is however evidence of harm with some 750,000 calls made to poison centres since January 2000 and 1,500 visits to emergency rooms by children under two who had taken these products between 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: The harms associated with cough and cold medications for children appear to outweigh any potential benefits. Clinicians should avoid recommended or supporting the use of these products. Pharmacies should also avoid recommending these products and may even consider removing them from sale.
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