Abstract
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency has issued European-wide restrictions on the use of codeine-containing medicines for cough and cold in children at the age of 0-12 because of the risk of serious side effects, including the risk of breathing problems. The PRAC further recommended that "codeine must not be used in people of any age who are known to convert codeine into morphine at a faster rate than normal ('ultra-rapid metabolisers')". The reasons for this variability in codeine biotransformation lay in a genetic polymorphism in the liver enzyme CYP2D6 leading to 3% of the northern European population being ultrarapid metabolisers due to a gene duplication of the enzyme.This is the first restriction of a common drug in CYP2D6 ultrarapid metabolizers, and more use of pharmacogenetic biomarkers for stratified benefit-risk assessment in drug regulation can be expected and will be a first step to Individualized Medicine Regulation.
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