FDA Pharmacogenomic biomarkers table updated 2016

Summary of the FDA Table of Pharmacogenomic Biomarkers in Drug Labeling


Kristen K. Reynolds, PhD
Sarah Schroer, PharmD
PGXL Laboratories
August 30, 2016

This is a list of medications approved by the FDA which have pharmacogenetic information in the product labeling or the drug package insert.  The table includes generic drug name, the therapeutic area with which the drug is most commonly associated, the gene (biomarker) referenced in the package insert, and the section of the drug label where that information can be found.

To date (list version 8/23/16), there are 164 unique drugs listed with some having multiple entries for multi-gene information.  The table is periodically updated, so the newest drugs with PGx information may not yet be listed.  For example, Rexulti (brexpiprazole) was approved in July 2015 with CYP2D6 gene-dose information, but was not added to the table until almost a year later during an update.


You can follow a link to a medication’s monograph directly from the FDA biomarkers table by clicking on the drug’s generic name listed in the table.  The table can be sorted by any of the column headers for ease of use.  Want to know how many drugs have labels referencing CYP2D6 in some way?  Just sort by biomarker.

The labeling section is a key aspect of this list.  It tells you exactly where to look in the drug’s package insert to find the information.  This is where it gets tricky…not all of the drugs in this table are DIRECTLY affected by the pharmacogenetic biomarker listed in the table.  The type and clinical relevance of biomarker information found in these different labels varies.  Read more for examples.

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Personalized, Precision, Genomic — What To Call What We Do

In any fast-emerging field, it takes a while for the terminology to standardize. It’s no different in pharmacogenetics. There is no concensus on whether to call what PGXL does personalized medicine, precision medicine, genomic medicine or something else.Search Term Use Personalized Med 050615

That lack of standardization may be confusing the public.

Research shows the general public doesn’t have a clue so far about this new type of medicine. In a survey last year of 1,024 consumers, the Washington DC-based Personalized Medicine Coalition found that 6 in 10 respondents had not heard the term personalized medicine. Among those who had heard the term, only 2 in 10 felt well-informed about it.

Google Trends notes the surge of interest in “precision medicine” (shows above, in red) after President Obama used the term, but for the last few years the most popular term has been “personalized medicine.” (The blue line on the chart.) That’s the term we use most around PGXL, because it keeps the focus on the patient in ways that genomic/precision/molecular don’t. They’re perfectly good terms, we just prefer to keep it personal.

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Pharmacy Practice: Pharmacogenetics is Crucial

Pharmacy Practice News assesses the Personalized Medicine landscape and concludes that continued development and implementation of pharmacogenetic testing and decision support technologies is crucial:

“This really is a drug-related issue. It’s natural for pharmacy to take a leadership role,” said Julie Johnson, PharmD, the dean of the University of Florida College of Pharmacy, and who led the launch of University of Florida’s pharmacogenomics program in 2012. “It’s pretty awesome that it’s risen on Obama’s radar,” she added. “It points to the vision that people are unique and that there are things we have to learn both from studies done on large populations and from teasing out differences in individuals.”

Evidence continues to underscore how variations in human genetic makeup may help explain differences in individual responses to treatments for cancer, HIV/AIDS and depression, among other health conditions. To date, 138 drugs including codeine, proton pump inhibitors, abacavir (Ziagen, ViiV) and irinotecan now have genetic data in their FDA-approved product labeling.


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