Pharmacogenomic biomarker information in drug labels approved by the United States Food and Drug Administration: Prevalence of related drug use

Pharmacotherapy

Volumn 28, Issue 8, 2008, Pages 992-998

  Frueh, Felix W ^a   Amur, Shashi ^a   Mummaneni, Padmaja ^a   Epstein, Robert S ^b   Aubert, Ronald E ^b   DeLuca, Teresa M ^b   Verbrugge, Robert R ^b   Burckart, Gilbert J ^a   Lesko, Lawrence J ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b Medco Health Solutions   (United States)

Author keywords

Biomarkers; Drug labels; FDA; Pharmacogenomics; Pharmacy benefits manager; U.S. Food and Drug Administration

Indexed keywords

AZATHIOPRINE; BIOLOGICAL MARKER; BUSULFAN; CAPECITABINE; CELECOXIB; CHLOROQUINE; CYTOCHROME P450; CYTOCHROME P450 2C19; CYTOCHROME P450 2D6; DAPSONE; EPIDERMAL GROWTH FACTOR RECEPTOR; ERLOTINIB; ESOMEPRAZOLE; FLUOROURACIL; FLUOXETINE; GEFITINIB; GLUCOSE 6 PHOSPHATE DEHYDROGENASE; IMATINIB; ISONIAZID; MERCAPTOPURINE; METOPROLOL; OMEPRAZOLE; RETINOIC ACID; RIFAMPICIN; STEM CELL FACTOR; TRASTUZUMAB; UNINDEXED DRUG; VALPROATE SEMISODIUM; VALPROIC ACID; WARFARIN;

ADULT; ARTICLE; CHILD; DATA BASE; DRUG APPROVAL; DRUG INFORMATION; DRUG LABELING; DRUG SAFETY; DRUG USE; FEMALE; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; GENETIC MARKER; GENETIC POLYMORPHISM; GENETIC VARIABILITY; HUMAN; INFORMATION CENTER; INFORMATION DISSEMINATION; INTERNET; MAJOR CLINICAL STUDY; MALE; OUTPATIENT; PHARMACOGENOMICS; PHARMACY BENEFIT MANAGER; PRESCRIPTION; RETROSPECTIVE STUDY; SCREENING; UNITED STATES;

BIOLOGICAL MARKERS; CYTOCHROME P-450 CYP2D6; DRUG APPROVAL; DRUG LABELING; DRUG UTILIZATION; HUMANS; PHARMACOGENETICS; RETROSPECTIVE STUDIES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 48249123433     PISSN: 02770008     EISSN: None     Source Type: Journal    
DOI: 10.1592/phco.28.8.992     Document Type: Article

References (22)

1. Woodcock J. The prospects for "personalized medicine" in drug development and drug therapy. Clin Pharmacol Ther 2007;81:164-9.
2. Lesko LJ. Personalized medicine: elusive dream or imminent reality? Clin Pharmacol Ther 2007;81:807-16.
3. Davies SM. Pharmacogenetics, pharmacogenomics and personalized medicine: are we there yet? Hematology Am Soc Hematol Educ Program 2006;1:111-17.
4. Fox JL. Despite glacial progress, U.S. government signals support for personalized medicine. Nat Biotechnol 2007;25:489-90.
5. Weatherall D. Sir David Weatherall reflects on genetics and personalized medicine. Drug Discov Today 2006;11:576-9.
6. U.S. Food and Drug Administration. Guidance for industry: pharmacogenomic data submissions. March 2005. Available from http://www.fda.gov/cber/gdlns/pharmdtasub.pdf. Accessed October 30, 2007.
7. Zineh I, Gerhard T, Aquilante CL, Beitelshees AL, Beasley BN, Hartzema AG. Availability of pharmacogenomics-based prescribing information in drug package inserts for currently approved drugs. Pharmacogenomics J 2004;4:354-8.
8. Zineh I, Pebanco GD, Aquilante CL, et al. Discordance between availability of pharmacogenetics studies and pharmacogenetics-based prescribing information for the top 200 drugs. Ann Pharmacother 2006;40:639-44.
9. Thomson Healthcare. Physicians' desk reference, electronic version. Available from http://www.pdr.net. Accessed October 30, 2007.
10. U.S. Food and Drug Administration. Drugs@FDA: FDA-approved drug products. Available from http://www.accessdata.fda.gov/scripts/cder/drugsatfda/. Accessed October 30, 2007.
11. Lacana E, Amur S, Mummanneni P, Zhao H, Frueh FW. The emerging role of pharmacogenomics in biologics. Clin Pharmacol Ther 2007;82:466-71.
12. Mummaneni P, Amur S, Goodsaid F, Rudman A, Frueh FW. Genomic biomarkers in FDA-approved drug labels [abstract]. J Clin Pharmacol 2006;46:1088.
13. U.S. Food and Drug Administration. Table of valid genomic biomarkers in the context of approved drug labels. Available from http://www.fda.gov/cder/genomics/genomic_biomarkers_table.htm. Accessed October 30, 2007.
14. Grice GR, Seaton TL, Woodland AM, McLeod HL. Defining the opportunity for pharmacogenetic intervention in primary care. Pharmacogenomics 2006;7:61-5.
15. Calvert J, Lehmann H, Silk E, Slack WK. Prolonged apnoea after suxamethonium: a case study of pseudocholinesterase. Lancet 1954;267:354-6.
16. Mitchell JR, Thorgeirsson UP, Black M, et al. Increased incidence of isoniazid hepatitis in rapid acetylators: possible relation to hydrazine metabolites. Clin Pharmacol Ther 1975;18:70-9.
17. Davies DM, Beedie MA, Rawlins MD. Antinuclear antibodies during procainamide treatment and drug acetylation. Br Med J 1975;3:682-3.
18. Phillips KA, Veenstra DL, Oren E, Lee JK, Sadee W. Potential role of pharmacogenomics in reducing adverse drug reactions: a systematic review. JAMA 2001;286:2270-9.
19. Koren G, Cairns J, Chitayat D, et al. Pharmacogenetics of morphine poisoning in a breastfed neonate of a codeine-prescribed mother. Lancet 2006;368:704.
20. Borges S, Desta Z, Li L, et al. Quantitative effect of CYP2D6 genotype and inhibitors on tamoxifen metabolism: implication for optimization of breast cancer treatment. Clin Pharmacol Ther 2006;80:61-74.
21. Goetz MP, Knox SK, Suman VJ, et al. The impact of cytochrome P450 2D6 metabolism in women receiving adjuvant tamoxifen. Breast Cancer Res Treat 2007;101:113-21.
22. Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group. Recommendations from the EGAPP working group: testing for cytochrome P450 polymorphisms in adults with nonpsychotic depression treated with selective serotonin reuptake inhibitors. Genet Med 2007;9:819-25.