BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Codeine: Genetic polymorphism - paediatric deaths

Active substance: codein

Recently, the U.S. licencing authority FDA reported three cases of death and one case of life-threatening respiratory depression following administration of codeine to children between 2 and 5 years of age. According to FDA statements the three children who died were "ultra-rapid" metabolisers, the fourth child was an "extensive" metaboliser.

risk information - full text (available in German only)