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

Reis-Pardal, J; Rodrigues, A; Rodrigues, E; Fernandez-Llimos, F

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

Reis-Pardal, J Rodrigues, A Rodrigues, E Fernandez-Llimos, F

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Publication Type:: Journal Article
Citation:: Pharmacogenomics Journal, 2017, 17 (6), pp. 488 - 493
Issue Date:: 2017-12-01

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Field	Value	Language
dc.contributor.author	Reis-Pardal, J	en_US
dc.contributor.author	Rodrigues, A	en_US
dc.contributor.author	Rodrigues, E	en_US
dc.contributor.author	Fernandez-Llimos, F https://orcid.org/0000-0002-8529-9595	en_US
dc.date.available	2016-05-02	en_US
dc.date.issued	2017-12-01	en_US
dc.identifier.citation	Pharmacogenomics Journal, 2017, 17 (6), pp. 488 - 493	en_US
dc.identifier.issn	1470-269X	en_US
dc.identifier.uri	http://hdl.handle.net/10453/126072
dc.description.abstract	© 2017 Macmillan Publishers Limited, part of Springer Nature. All rights reserved. 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.	en_US
dc.relation.ispartof	Pharmacogenomics Journal	en_US
dc.relation.isbasedon	10.1038/tpj.2016.40	en_US
dc.subject.classification	Pharmacology & Pharmacy	en_US
dc.subject.mesh	Humans	en_US
dc.subject.mesh	Cytochrome P-450 Enzyme System	en_US
dc.subject.mesh	Pharmaceutical Preparations	en_US
dc.subject.mesh	Drug Labeling	en_US
dc.subject.mesh	Pharmacogenetics	en_US
dc.subject.mesh	Polymorphism, Genetic	en_US
dc.subject.mesh	United States Food and Drug Administration	en_US
dc.subject.mesh	European Union	en_US
dc.subject.mesh	United States	en_US
dc.subject.mesh	Precision Medicine	en_US
dc.subject.mesh	Pharmacogenomic Testing	en_US
dc.title	Comparing cytochrome P450 pharmacogenetic information available on United States drug labels and European Union Summaries of Product Characteristics	en_US
dc.type	Journal Article
utslib.citation.volume	6	en_US
utslib.citation.volume	17	en_US
utslib.for	1115 Pharmacology and Pharmaceutical Sciences	en_US
pubs.embargo.period	Not known	en_US
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Graduate School of Health
utslib.copyright.status	closed_access
pubs.issue	6	en_US
pubs.publication-status	Published	en_US
pubs.volume	17	en_US

Abstract:

© 2017 Macmillan Publishers Limited, part of Springer Nature. All rights reserved. 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.

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http://hdl.handle.net/10453/126072