12,000

We have over 12,000 students, from over 100 countries, within one of the safest campuses in the UK

93%

93% of Lancaster students go into work or further study within six months of graduating

Home > Research > Publications & Outputs > Pharmacogenomic biomarkers in drug labels
View graph of relations

« Back

Pharmacogenomic biomarkers in drug labels: what do they tell us?

Research output: Contribution to journalJournal article

Forthcoming

Journal publication date2014
JournalPharmacogenomics
Journal number3
Volume15
Original languageEnglish

Abstract

This article investigates the number of drugs on the market with PGx biomarker data in their labels using two public sources – the FDA and the PharmKGB (Pharmacogenomics Knowledge Base). The article analyzes the FDA Table of Pharmacogenomic Biomarkers in Drug Labels to show the number of drugs with PGx biomarker information in their labels. Scrutinizing the language of labels, it also engages with whether this information is intended to direct clinicians to take particular actions or not, and whether biomarker information it is included on grounds of drug efficacy or to improve safety. The FDA table is compared to the PharmKGB Drug Labels with PGx info database to highlight how they differ in the number of drugs which they include. Analysis of the FDA and the Pharmkgb data show that in approximately 12% of drugs licensed in the period 1998-2012 had PGx biomarker information included in their labels at the time of their approval. Of that number, labels only direct clinicians to utilize PGx testing prior to prescribing treatments in only 14 cases. This clearly falls short of expectations many had in the 1990s about the transformative impact of PGx. In most cases, the inclusion of this information currently has limited or no direct clinical utility.