Codeine not to be used for cough in children, says UK MHRA

The UK MHRA has declared that the risks associated with the use of OTC oral liquid cough medicines containing codeine outweigh any benefits among paediatric individuals aged < 18 years.1

This advice follows a UK review of available literature, from which the Commission on Human Medicines and its Paediatric Medicines Expert Advisory Group concluded that oral liquid codeine-containing medicines should not be used to treat cough in paediatric individuals, and that all such medicines should now be supplied in child-resistant containers.

In a Drug Safety Update, the MHRA says that specific paediatric studies on the use of codeine are needed, as the differences between children and adults in drug handling or drug effects may lead to different dosage requirements.2 Manufacturers are currently updating their packaging and leaflets to comply with the new recommendations, which will take effect in April 2011. In the meantime, pharmacists are asked to consider the new advice when selling existing stock of codeine-containing products.

A reminder about the possibility of toxicity among breastfed neonates if the mother is an ultra metaboliser of codeine has also been issued by the MHRA.

[Reference]

1. Medicines and Healthcare Products Regulatory Agency.Oral liquid cough medicines containing codeine: should not be used in children and young people under 18 years. Internet Document: [1 page], 11 Oct 2010. Available from: URL: http://www.mhra.gov.uk. .

2. Codeine-containing liquid over-the-counter medicines: should not be used for cough under 18 years. Drug Safety Update 4: H3, No. 3, Oct 2010.