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Regulatory Focus™ > News Articles > EU Committee Wants Additional Restrictions on Codeine Use in Children

EU Committee Wants Additional Restrictions on Codeine Use in Children

Posted 16 March 2015 | By Michael Mezher 

EU Committee Wants Additional Restrictions on Codeine Use in Children

A European committee is recommending a series of restrictions on the use of medicines containing codeine in children.

PRAC’s Recommendations

Citing concerns that codeine can cause breathing problems and other serious adverse effects in children, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is recommending codeine be contraindicated for children less than 12 years of age. Additionally, PRAC says that children between ages 12 and 18 with breathing problems should not take medicine containing codeine. The committee is also asking that liquid codeine-containing drugs come in child-proof packaging.

When codeine is ingested it is converted into morphine. This happens in both children and adults; however, the rate of conversion is more variable in children, which can make side effects less predictable.

Before a final guidance is adopted, the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) will review PRAC’s recommendations on the issue. For the time being, EMA is recommending that patients consult their healthcare providers if they have any concerns regarding pediatric codeine use.

Building on Precedent

These recommendations follow a 2012-2013 review, which recommended codeine only be given to children under 12 as a last resort after less dangerous painkillers such as paracetamol or ibuprofen. PRAC’s new recommendations are more restrictive than before, and if adopted, would completely restrict codeine use in children under 12.

The recommendations also go a step further than recent requirements by the US Food and Drug Administration (FDA). In 2013, FDA issued a requirement for prescription codeine products to be labelled with a black box warning to inform consumers of the risk of fatal complications in children taking codeine after certain surgeries.


EMA Press Release


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