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Pharmacogenomics J. 2017 Dec;17(6):488-493. doi: 10.1038/tpj.2016.40. Epub 2016 May 31.

Comparing cytochrome P450 pharmacogenetic information available on United States drug labels and European Union Summaries of Product Characteristics.

Author information

1
Faculty of Pharmacy, Research Institute for Medicines (iMed.ULisboa), University of Lisbon, Lisbon, Portugal.
2
Post-Graduate Program in Regulatory Affairs, Faculty of Pharmacy, University of Lisbon, Lisbon, Portugal.
3
Institute for Medicines (iMed.ULisboa), Department of Biochemistry and Human Biology, Faculty of Pharmacy, Research University of Lisbon, Lisbon, Portugal.
4
Research Institute for Medicines (iMed.ULisboa), Department of Social Pharmacy, Faculty of Pharmacy, University of Lisbon, Lisbon, Portugal.

Abstract

Regulatory agencies are increasing the pharmacogenomic information in their official drug labeling. However, despite the importance of regulatory harmonization, this implementation may not be running in parallel among major agencies. Comparing labeling of medicines approved by different agencies may identify gaps to solve. Our study compared the cytochrome P450 pharmacogenetic information included in the United States (US) Food and Drug Administration (FDA) drug labels and European Union (EU) Summaries of Product Characteristics (SmPCs). US labels presented significantly more specific pharmacogenetic subheadings (51 vs 26%), more prevalence and pharmacokinetic data for each metabolic phenotype (59 vs 25% and 82 vs 48%, respectively) and more applicable information about dose modifications required (25 vs 5%). Approximately 75% of the US labels evaluated scored higher on the overall quality than the analogous EU SmPCs, and this difference was not associated with the time since the EU SmPCs' last review. To enhance harmonization, regulatory agencies should simultaneously introduce the pharmacogenetic information in their drug labeling.

PMID:
27241061
DOI:
10.1038/tpj.2016.40
[Indexed for MEDLINE]

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