The European Medicines Agency (EMA) is recommending that codeine-containing products used to treat coughs and colds should be banned for those aged under 12 years.
The products — available on prescription and, in some countries, over the counter — should also no longer be made available to anyone under 18 years of age if they have breathing problems.
“This is important advice about the use of codeine to treat cough and cold in children,” says Sarah Branch, deputy director of the vigilance and risk management of medicines division at the UK Medicines and Healthcare products Regulatory Agency (MHRA). “While codeine is not commonly used in children, the evidence is clear that there is a risk of side effects.”
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has further recommended that codeine should not be used by people of any age who are known to convert codeine into morphine at a faster rate than normal. The move follows safety concerns originally raised by medicines regulators in Germany in April 2014.
The proposed ban for paediatric products applies to a range of medicines available across the European Economic Area either with or without a prescription. The recommendation still has to be ratified by the European Union’s Co-ordination Group for Mutual Recognition and Decentralised Procedures.
The products — listed on the EMA’s website — include the formulations tablets, capsules, oral drops and rectal suppositories. All liquid codeine medicines should also only be available in child-resistant containers, it recommends.
PRAC is also advising that breast-feeding mothers should not take any codeine-containing products because the drug can be passed to the baby through breast milk.
In the UK, the PRAC recommendation only affects two products — a linctus containing codeine phosphate (0.3% w/v) and an oral solution containing codeine phosphate (0.5% w/v). Both products are manufactured by Wise Pharmaceuticals in Manchester and are only available on prescription, according to the MHRA.
“If anyone has any questions they should speak to their GP or pharmacist who can best advise on alternative treatments,” adds Branch.
The PRAC recommendation would further restrict the availability of codeine-containing medicines for children in the UK following a 2011 decision by the MHRA.
The MHRA banned the sale of all Pharmacy (P) medicines containing codeine for the treatment of cough for children under 18 years of age following a safety review. It concluded that the benefits of the products did not outweigh the risks. It also decided at the time that any codeine-containing products should be available only in child-resistant packaging.