Pharmacogenomic biomarker information in drug labels approved by the United States food and drug administration: prevalence of related drug use.
OBJECTIVE
To review the labels of United States Food and Drug Administration (FDA)-approved drugs to identify those that contain pharmacogenomic biomarker information, and to collect prevalence information on the use of those drugs for which pharmacogenomic information is included in the drug labeling.


METHODS
Retrospective analysis.


METHODS
The Physicians' Desk Reference Web site, Drugs@FDA Web site, and manufacturers' Web sites were used to identify drug labels containing pharmacogenomic information, and the prescription claims database of a large pharmacy benefits manager (insuring > 55 million individuals in the United States) was used to obtain drug utilization data.


RESULTS
Pharmacogenomic biomarkers were defined, FDA-approved drug labels containing this information were identified, and utilization of these drugs was determined. Of 1200 drug labels reviewed for the years 1945-2005, 121 drug labels contained pharmacogenomic information based on a key word search and follow-up screening. Of those, 69 labels referred to human genomic biomarkers, and 52 referred to microbial genomic biomarkers. Of the labels referring to human biomarkers, 43 (62%) pertained to polymorphisms in cytochrome P450 (CYP) enzyme metabolism, with CYP2D6 being most common. Of 36.1 million patients whose prescriptions were processed by a large pharmacy benefits manager in 2006, about 8.8 million (24.3%) received one or more drugs with human genomic biomarker information in the drug label.


CONCLUSIONS
Nearly one fourth of all outpatients received one or more drugs that have pharmacogenomic information in the label for that drug. The incorporation and appropriate use of pharmacogenomic information in drug labels should be tested for its ability to improve drug use and safety in the United States.
Frueh
Felix W
FW
Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA), Silver Spring, MD 20993, USA.
Amur
Shashi
S
Mummaneni
Padmaja
P
Epstein
Robert S
RS
Aubert
Ronald E
RE
DeLuca
Teresa M
TM
Verbrugge
Robert R
RR
Burckart
Gilbert J
GJ
Lesko
Lawrence J
LJ
D015415:Biomarkers; D019389:Cytochrome P-450 CYP2D6 / Q000502:physiology; D017277:Drug Approval; D004348:Drug Labeling; D004363:Drug Utilization; D006801:Humans; D010597:Pharmacogenetics; D012189:Retrospective Studies; D014481:United States; D014486:United States Food and Drug Administration
D015415:Biomarkers; D019389:Cytochrome P-450 CYP2D6