Use of codeine no longer indicated in children with cough under 12 years of age

Safety warnings | messages in brief | 22/10/2015

The Federal Agency informs about recommendations of the Committee for Risk Assessment and Pharmacovigilance (PRAC, BASG initial notification 13.3.2015) and the subsequent decision within the European risk assessment procedure according to Article 31 of Directive 2001/83/EC regarding the use of codeine for cough and cold in children (update).

Action at EU level

Due to the risk for serious adverse reactions, in particular respiratory disorders, the use of codeine-containing medicinal products for cough and cold is contraindicated in children under 12 years of age.

The decision reads:

Codeine is contraindicated for cough and cold in children 12 years of age and younger. This means that it may not be used in this patient group in the future.

In adolescents between 12 and 18 years of age, codeine-containing drugs are not recommended for coughs and colds if these patients already have respiratory disorders.

Codeine should also no longer be used in patients of any age who are known to convert codeine to morphine more rapidly than normal.

Codeine must also not be used in nursing mothers, as codeine is passed on to the infant through breast milk.

Codeine achieves its known pharmacological effects primarily through the metabolic conversion of codeine to morphine that occurs in the body. However, some patients convert codeine to morphine much more rapidly than usual (so-called ultra-rapid metabolizers), which can result in high blood levels of morphine. High morphine levels can lead to severe side effects, particularly life-threatening respiratory depression.

Although these side effects can generally occur in patients of all ages, morphine conversion is highly variable and difficult to predict, particularly in children. Therefore, this age group is at particular risk for side effects. If children are already known to have problems with breathing or have a short-term respiratory impairment, these children and also adolescents are particularly susceptible to side effects associated with codeine.

Because coughs and colds are self-limiting illnesses, i.e., they usually resolve on their own without specific therapy, and furthermore because the data that codeine is an effective therapy for coughs are limited, codeine therapy should be critically evaluated for its individual necessity.

Comparable restrictions related to the use of codeine were already made about two years ago in the context of another European risk assessment procedure. The procedure at that time had evaluated the use of codeine for the treatment of pain in children. The current restrictions now recommended for the treatment of coughs and colds in children also largely correspond to the restrictions previously made for the use of codeine for pain relief in children.

Situation in Austria

The following medicinal products are approved in Austria: