Pharmacogenomics and adverse drug reactions

Personalized Medicine

Volumn 7, Issue 6, 2010, Pages 633-642

  Amur, Shashi ^a   Zineh, Issam ^a   Abernethy, Darrell R ^a   Huang, Shiew Mei ^a   Lesko, Lawrence J ^a  

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

Author keywords

adverse drug reaction; CYP; drug label; drug safety; drug metabolizing enzymes; genetic; genomic; polymorphism; variant

Indexed keywords

ABACAVIR; CARBAMAZEPINE; CLOPIDOGREL; CODEINE; CYTOCHROME P450 2C19; CYTOCHROME P450 2C9; CYTOCHROME P450 2D6; DRUG METABOLIZING ENZYME; IRINOTECAN; MORPHINE; SIMVASTATIN; WARFARIN;

ALTERNATIVE MEDICINE; ARTICLE; BLEEDING; DRUG LABELING; DRUG MARKETING; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HUMAN; HYPERSENSITIVITY REACTION; MYOPATHY; NEUTROPENIA; NONHUMAN; PHARMACODYNAMICS; PHARMACOGENOMICS; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; RISK REDUCTION; STEVENS JOHNSON SYNDROME; TOXIC EPIDERMAL NECROLYSIS;

EID: 78649995976     PISSN: 17410541     EISSN: 1744828X     Source Type: Journal    
DOI: 10.2217/pme.10.63     Document Type: Article

References (40)

1. Berndt ER, Gottschalk AHB, Philipson TJ, Strobeck MW: Industry funding of the FDA: effects of PDUFA on approval times and withdrawal rates. Nat. Rev. Drug Discov. 4, 545-554 (2005).
2. Gurwitz JH, Field TS, Avorn J et al.: Incidence and preventability of adverse drug events in nursing homes. Am. J. Med. 109, 87-94 (2000).
3. Ge F, He Q-Y: Genomic and proteomic approaches for predicting toxicity and adverse drug reactions. Expert Opin. Drug Metab. Toxicol. 5(1), 29-37 (2009).
4. Lazarou J, Pomeranz BH, Corey PN: Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 279(15), 1200-1205 (1998).
5. Yap CW, Cai CZ, Xue Y et al.: Prediction of torsade causing potential of drugs by support vector machine approach. Toxicol. Sci. 79, 170-177 (2004).
6. Kola I, Landis L: Can the pharmaceutical industry reduce attrition rates? Nat. Rev. Drug Discov. 3, 711-715 (2004).
7. Berlin JA, Glasser SC, Ellenberg SS: Adverse event detection in drug development: recommendations and obligations beyond Phase 3. Am. J. Pub. Health 98 (8), 1366-1371 (2008).
8. Woodcock J, Lesko LJ: Pharmacogenetics-tailoring treatment for the outliers. N. Engl. J. Med. 360(8), 811-813 (2009).
9. Phillips KA, Veenstra DL, Oren E et al.: Potentail role of pharmacogenomics in reducing adverse drug reactions. A systematic review. JAMA 286, 2270-2279 (2001).
10. Nebeker JR, Hoffman JM, Weir CB et al.: High rates of adverse drug events in a highly computerized hospital. Arch. Intern. Med. 165, 1111-1116 (2005).
11. Huang S-M, Temple R: Is this the drug or dose for you?-impact of ethnic factors in global drug development, regulatory review and clinical practice. Clin. Pharmacol. Ther. 84(3), 287-294 (2008).
12. Solus JF, Arietta BJ, Harris JR et al.: Genetic variation in eleven Phase I drug metabolism genes in an ethnically diverse population. Pharmacogenomics 5(7), 895-931 (2004).
13. Amur S, Frueh F, Lesko LJ, Huang, S-M: Integration and use of biomarkers in drug development, regulation and clinical practice-a U.S. Regulatory Perspective Biomarkers in Clinical Pharmacology Review. Biomarkers Med. 2(3), 305-311 (2008).
14. Bozina N, Bradamante V, Lovric M: Genetic polymorphism of metabolic enzymes p450 (CYP) as a susceptibility factor for drug response, toxicity, and cancer risk. Arh. Hig Rada. Toksikol. 60, 217-242 (2009).
15. Ginghina C, Stenescu R, Coman IM et al.: Understanding the genetic causes of inter-patient variability. Clinical relevance with focus on cardiovascular drugs. Rom. J. Intern. Med. 45(4), 313-319 (2007).
16. Roederer MW: Cytochrome P450 enzymes and genotype-guided drug therapy. Curr. Opin. Mol. Ther. 11(6), 632-640 (2009).
17. Lenzini P, Wadelius M, Kimmel S et al.: Integration of genetic, clinical, and INR data to refne warfarin dosing. Clin. Pharmacol. Ther. 87(5), 572-578 (2010).
18. Mega JL, Close SL, Wiviott SD: Cytochrome P-450 polymorphisms and response to clopidogrel. N. Engl. J. Med. 360(4), 354-362 (2009).
19. Kirchheiner J, Schmidt H, Tzvetkov M et al.: Pharmacokinetics of codeine and its metabolite morphine in ultra-rapid metabolizers due to CYP2D6 duplication. Pharmacogenomics. J. 7(4), 257-265 (2007).
20. Innocenti F, Ratain MJ: Pharmacogenetics of irinotecan: clinical perspectives on the utility of genotyping. Pharmacogenomics 7(8), 1211-1221(2006).
21. Hoskins JM, Goldberg RM, Pingping Q et al.: UGT1A1*28 genotype and irinotecan-induced neutropenia: dose matters. J. Natl Cancer Inst. 99(17), 1290-1295 (2007).
22. Ghatak A, Faheem O, Thompson PD: The genetics of statin-induced myopathy. Atherosclerosis 210, 337-343 (2010).
23. SEARCH Collaborative Group, Link E, Parish S et al.: SLCO1B1 variants and statin-induced myopathy-a genome wide study. N. Engl. J. Med. 359(8), 789-799 (2008).
24. Voora D, Shah SH, Spasojevic I et al.: The SLCO1B1*5 genetic variant is associated with statin-induced side effects. J. Am. Coll. Cardiol. 54, 1609-1616 (2009).
25. International Transporter Consortium (ITC); Giacomini KM, Huang S-M, Tweedie DJ et al.: Membrane transporters in drug development: report from the FDA Critical Path Initiative Sponsored Workshop. Nat. Rev. Drug Disc. 9, 215-236 (2010).
26. Huang S-M, Woodcock J: Commentary on ITC Membrane Transporters in Drug Development; Report from the FDA Critical Path Initiative Sponsored Workshop. Nat. Rev. Drug Disc. 9, 175-176 (2010).
27. Huang S-M, Zhang L, Giacomini KM: The International Transporter Consortium (ITC): a collaborative group of scientists from academia, industry and FDA. Clin. Pharmacol. Ther. 87, 32-36 (2010).
28. Wadelius M, Chen LY, Downes K et al.: Common VKORC1 and GGCX polymorphisms associated with warfarin dose. Pharmacogenomics J. 5, 262-270 (2005).
29. Epstein RS, Moyer TP, Aubert RE et al.: Warfarin genotyping reduces hospitalization rates. Results from the MM-WES (Medco-Mayo Warfarin Effectiveness Study). J. Am. Coll. Cardiol. 55(25), 2804-2812 (2010).
30. Gandara E, Wells PS: Will there be a role for genotyping in warfarin therapy? Curr. Opin. Hematol. 17(5), 439-443 (2010).
31. Mallal S, Nolan D, Witt C et al.: Association between presence of HLA-B*5701, HLA-DR7, and HLA-DQ3 and hypersensitivity to HIV-1 reverse-transcriptase inhibitor abacavir. Lancet 359, 727-732 (2002).
32. Hetherington S, Hughes AR, Mosteller M: Genetic variations in HLA-B region and hypersensitivity reactions to abacavir. Lancet 359, 1121-1122 (2002).
33. Hughes AR, SpreenWR, Mosteller M et al.: Pharmacogenetics of hypersensitivity to abacavir: from PGx hypothesis to confrmation to clinical utility Pharmacogenomics J. 8(6), 365-374 (2008).
34. Hughes CA, Foisy MM, Dewhurst N et al.: Abacavir hypersensitivity reaction: an update. Ann. Pharmacother. 42, 387-396(2008).
35. Sun H-Y, Hung C-C, Lin P-H et al.: Incidence of abacavir hypersensitivity and its relationship with HLA-B*S701 in HIV-infected patients in Taiwan. J. Antimicrob. Chemother. 60, 599-604 (2007).
36. Chung W-H, Chen Y-T: HLA-B genotyping to detect carbamazepine-induced Stevens-Johnson syndrome: implications for personalized medicine. Per. Med. 2(3), 225-237 (2005).
37. Frueh FW, Amur S, Mummaneni P et al.: Pharmacogenomic biomarker information in drug labels approved by the United States Food and Drug Administration: prevalence of related drug use. Pharmacotherapy 28(8), 992-998 (2008).
38. Zineh I, Lesko LJ: Pharmacogenetics in medicine: barriers, critical factors and a framework for dialogue. Pers. Med. 6(4), 359-361 (2009).
39. Goodsaid FM, Blank M, Dieterle F et al.: Novel biomarkers of acute kidney toxicity. Clin. Pharmacol. Ther. 86, 490-496 (2009).
40. Daly AK: Drug induced liver injury, past, present and future. Pharmacogenomics 11(5), 607-611 (2010