- Medicines and Healthcare products Regulatory Agency
- Therapeutic area:
- Ear, nose and throat, Paediatrics and neonatology, and Respiratory disease and allergy
Should not be used for cough under 18 years
Article date: October 2010
We have completed an evaluation of the benefits and risks of over-the-counter (OTC) oral liquids containing codeine for the treatment of cough in children, based on all available data. These products are currently available for supply by a pharmacist.
Risks and benefits of codeine as a cough suppressant
The Commission on Human Medicines and its Paediatric Medicines Expert Advisory Group have advised that codeine-containing OTC liquid medicines should not be used for cough suppression in children and young people younger than age 18 years.
Manufacturers are currently updating the packaging and leaflets for OTC liquid cough medicines that contain codeine to include the updated advice. The new information will begin to appear in pharmacies from April 2011, and in the meantime existing packaged medicines will continue to be sold and pharmacists have been asked to consider the new advice when recommending cough medicines for children.
Coughs and colds are self-limiting conditions
Coughs and colds occur frequently in children, but they are self-limiting and rarely harmful if left untreated. Coughs have a physiological function of clearing mucus secretions from the airways. Many medicines given to children have not been properly studied in this age-group. Specific paediatric studies are needed because of differences between adults and children in drug handling or drug effects, which may lead to different dose requirements.
In February 2009, we announced a package of measures to ensure safer use of other over-the-counter (OTC) cough and cold medicines for children younger than age 12 years. The MHRA is working to improve the availability of high-quality, ethically researched and properly authorised medicines for children.
Reminder: codeine and very rare risk of side effects in breastfed babies
Healthcare professionals are reminded that breastfed babies might very rarely develop side effects due to the presence of morphine in breast milk. Further information is available from the November 2007 issue of Drug Safety Update.
Further information on the review of the benefits and risks of OTC oral liquids containing codeine for the treatment of cough in children is available in a report available on our website.
Article citation: Drug Safety Update Oct 2010, vol 4 issue 3: H3.