Summary of the FDA Table of Pharmacogenomic Biomarkers in Drug Labeling
Kristen K. Reynolds, PhD
Sarah Schroer, PharmD
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.