Annotation of Pharmaceuticals and Medical Devices Agency, Japan (PMDA) label information
for codeine
and CYP2D6
Summary
The PMDA package insert for codeine notes that CYP2D6 ultrarapid metabolizers are at increased risk of developing side effects due to high serum levels of morphine, and that they may also have higher morphine levels in breast milk.
Annotation
Please note that the information contained within this drug label annotation is available through a collaboration with the Japanese Society of Pharmacogenomics, who provided a translation of the pharmacogenetic information contained in the PMDA package insert.
Excerpts from the codeine package insert:
In patients who are known to have high CYP2D6 activity (i.e., ultra-rapid metabolizers), use of this product may lead to higher morphine levels in breast milk.
Patients who are genetically known to have high CYP2D6 activity (i.e., ultra-rapid metabolizers) are at increased risk of developing side effects associated with higher than expected serum levels of the active metabolite of the product, morphine.
For the complete drug label text with sections containing pharmacogenetic information highlighted, see the codeine package insert (in Japanese).
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