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In December 2022, the European Medicines Agency (EMA) recommended withdrawal of pholcodine-containing medicines from European Union (EU) market, both in over-the-counter (OTC) and prescription medicines.1 Meanwhile, recalls have been announced in Australia (February 2023)2 and now in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA) on 14 March 2023.3 Most cough medicines in the UK do not contain pholcodine, those that do include DayNurse and some own-brand medicines from Boots.4
Pholcodine is a weak opiate developed in the 1950s for the treatment of non-productive cough in children and adults. It has a direct central effect in suppressing the cough reflex. Unlike codeine, it is not metabolised to morphine and therefore considered non-addictive. Compared with codeine, animal and human adult studies of induced cough reveal marginally greater antitussive efficacy.5 Despite its availability in OTC preparations, there are remarkably few published trials and successive systematic reviews that have suggested there is no good evidence for or against the use of any OTC cough medication in adults and insufficient data to draw any conclusions in children.6 7
A randomised double-blind parallel group study in adults with non-productive cough compared pholcodine with dextromethorphan (but not placebo). On day 3 of treatment, there was a small reduction in cough intensity and day-time cough frequency, but in the absence of a placebo comparison these benefits are unconvincing.8 Arguably, honey may be both safer and more effective: a systematic review reported efficacy in children over 1 year of age (honey should be avoided in infants due to risk of botulism), particularly during the first 3 days of symptom onset, compared with no benefit from OTC cough remedies.9
In 2012, due to concerns over the side effects of codeine …
Contributors PT and JOW both conceived and drafted the manuscript together and approved the final version.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Provenance and peer review Commissioned; internally peer reviewed.