Codein: Neue Anwendungsbeschränkungen bei Kindern und Jugendlichen

Zusammenfassung

Wegen erhöhter Anfälligkeit für Atemstörungen wird auch für Kinder und Jugendliche im Alter von 12–18 Jahren Codein nicht mehr empfohlen. Aber nicht nur bei Kindern mit Husten, sondern auch für Patienten jeglichen Alters die „Codein sehr schnell zum Morphin verstoffwechseln“ sind codeinhaltige Arzneimittel ab sofort kontraindiziert. Zugrunde liegt ein pharmakogenetischer Polymorphismus, also genetisch bedingte Unterschiede im Arzneimittelstoffwechsel eines körpereigenes Leberenzyms der “Cytochrom-P450-Familie“, das CYP2D6, das Medikamente und Fremdstoffe mehr oder weniger schnell in unserem Körper abbaut. Wir erwarten, dass in Zukunft durch genetische oder molekulare Marker eine noch genauere und besser stratifizierte Einschätzung des Nutzen-Risikoverhältnisses bei Arzneimitteln für verschiedene Patientengruppen im Sinne einer “individualisierte Medizin“ möglich wird.

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.

Schlüsselwörter

Codein - CYP2D6 - pharmakogenetischer Polymorphismus

Keywords

codeine - CYP2D6 - pharmacogenetic polymorphisms

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