The European and French Medicines Agencies recommend no longer giving codeine to children under 12 years of age. An excessive measure and which will pose a problem, according to the doctors.
Since last week, the European Medicines Agency (EMA) has advised reducing the use of codeine in the treatment of pediatric pain. These recommendations follow the observations of American doctors who have observed in children an increased risk of respiratory depression, following several surgical interventions (tonsillectomy and adenoidectomy), and pain treatments with these analgesics. But also, “a very low number of serious cases, even fatal”, specifies for its part the National Agency for the Safety of Medicines (Ansm).
Following these accidents, Spain and the United Kingdom then carried out an assessment of the benefit / risk ratio. These are the first elements that led Ema to advise against the use of codeine for children under 12 years old. Pending final conclusions from Europe, Ansm has aligned itself with this position. It also recommends that codeine be used in children over 12 years old only after paracetamol and / or NSAIDs have failed. Finally, codeine is not recommended for breastfeeding women.
However, this recommendation worries French doctors.
For the Dr Christine Ricard, head of the center for analgesia and pediatric palliative care at the University Hospital of Montpellier, this “excessive” decision is “likely to put certain children at risk”.
Precautionary principle: an excessive position for French doctors
Dr Christine Ricard: We went froma principle of prudence to a principle of precaution on few accidents finally and on children treated at home who had related pathologies and who in addition had a survival which also led to possible obstructions of the respiratory tract. To go to a recommendation for children under 12 is, in my opinion, excessive.
France: successful experimentation with a prudent dosage
Dr Christine Ricard: We had adapted for 3-4 years, in France, a dosage of codeine which was no longer of the order of 1 mg / kg but of the order of 0.5 mg / kg. In order to readjust the dose if necessary on these children who are rapid metabolizers. Because of this careful adaptation, we have not experienced this type of accident at home.
A new complicated management
Dr Christine Ricard: Currently, when you take away codeine, you don’t have much for a small child who is 1 year old. We are going to give him paracetamol, but we have a lot of reservations about anti-inflammatory drugs. We could give morphine straight away at 6 months or 1 year old. At present, we do not have the right presentations to protect us from overdose. Average pain, everyday pain, these will be very disadvantaged by the withdrawal of codeine.
The risks unrecognized alternative treatments
Dr Christine Ricard: From the age of 3, they can receive another molecule called tramadol, which we are not sure will not also have rapid metaboliser effects. It is also possible to envisage the administration of another molecule which is given essentially intravenously and incidentally by the rectal route.
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