PharmGKB Drug Labels: Description, Update and New Features

PharmGKB has recently added new information to drug label entries, standardized the annotations, and updated the website display.  The overview page for drug labels contains high level information about each label at a glance, including:

• Whether the drug label is currently on the FDA's Table of Pharmacogenomic Biomarkers in Drug Labels.  Drugs are occasionally added to and removed from this list, so it changes over time.
• The level of pharmacogenomic information in the label.  Does the label require or recommend genetic testing?  Or does the label merely mention genes involved in the metabolism of the drug without discussing gene variation?
• The date of the last major update to the label annotation on PharmGKB.

The user has the ability to sort by level of pharmacogenomic information or restrict the list of labels to those on the FDA's Biomarker list.

Drug label curation can be subjective, and some of the issues are discussed in a previous blog.  Below, we describe how the PharmGKB drug labels are sourced and curated, the updates we have just released, and new features of these labels.

FDA-approved drug labels

• Source:
• The most recent FDA-approved drug labels for drugs found in the FDA's Table of Pharmacogenomic Biomarkers in Drug Labels are retrieved through the link to Drugs@FDA or alternatively from DailyMed.
• Some labels are of FDA-approved drugs that are not within the PGx Biomarker table, however we have found PGx related information in them. These are sourced from DailyMed.
• Curation process:
• PharmGKB Curators download the PDF for the most recently approved label and highlight PGx-related information within this label. The PDF, along with a summary explaining the PGx and excerpts from the label, are added to the drug page.
• Labels are tagged with the Biomarker icon if they are found in the FDA's PGx Biomarker table.
• Each label is now assigned a PGx Level (see definitions):

• Phenotypes/diseases that have been found in the label by the PHONT (PGRN Ontology Network Resource) group are provided at the bottom section of PharmGKB's drug label page.  The phenotype terms from the drug label have been standardized to the MeSH ontology, and link to PharmGKB phenotype web pages.  The section(s) of the label in which each phenotype term was found is provided.
• Genes and/or phenotypes found in the label by manual curation may also be added by PharmGKB Curators.  This may include many genes not found in the Biomarker table that are discussed in the label.  The section(s) of the label in which each gene/phenotype term was found is provided.  In most cases, PharmGKB curators specify the relationship of the gene to the drug using these terms:  toxicity, dosage, efficacy, metabolism/PK.
• The date a label was last updated is provided on the drug label page. All FDA drug labels were updated on 25th October 2013.

EMA-approved drug labels

• Source:
• There is no PGx Biomarker table for European drug labels. We are working with the EMA to establish a list of European Public Assessment Reports (EPARs) that contain PGx information.
• We are constructing this list by initially searching for drugs in the FDA PGx Biomarker table - of these 44 EMA EPARs were identified.
• Curation process:
• PharmGKB Curators download the EPAR Product Information PDF and highlight PGx-related information within this label. The PDF, along with a summary explaining the PGx and excerpts from the label, are added to the drug page.
• A PGx level is added to each EMA label.

You can view all PharmGKB drug labels and Filter by PGx level or if they are found in the FDA's Biomarker table.