Comedications alter drug-induced liver injury reporting frequency: Data mining in the WHO VigiBase™

Regulatory Toxicology and Pharmacology

Volumn 72, Issue 3, 2015, Pages 481-490

  Suzuki, Ayako ^a   Yuen, Nancy A ^b   Ilic, Katarina ^c   Miller, Richard T ^b   Reese, Melinda J ^b   Brown, H Roger ^b   Ambroso, Jeffrey I ^b   Falls, J Gregory ^b   Hunt, Christine M ^d  

^a CENTRAL ARKANSAS VETERANS HEALTHCARE SYSTEM   (United States)

^b GLAXOSMITHKLINE   (United States)

^c Pharmacovigilance and Risk Management   (United States)

^d DURHAM VA MEDICAL CENTER   (United States)

Author keywords

Concomitant medications; Drug induced liver injury; Hepatotoxicity; Quantitative signal detection methods; Spontaneous adverse event reporting system

Indexed keywords

ALKYLATING AGENT; ALPHA ADRENERGIC RECEPTOR BLOCKING AGENT; AMOXICILLIN PLUS CLAVULANIC ACID; ANESTHETIC AGENT; ANTICONVULSIVE AGENT; ANTIVITAMIN K; BARBITURIC ACID DERIVATIVE; BETA 2 ADRENERGIC RECEPTOR BLOCKING AGENT; BILE ACID SEQUESTRANT; CEPHALOSPORIN DERIVATIVE; CORTICOSTEROID; CYCLOOXYGENASE 2 INHIBITOR; DIHYDROPYRIDINE DERIVATIVE; DIURETIC AGENT; EXPECTORANT AGENT; FOLIC ACID; HALOGENATED HYDROCARBON; HYDANTOIN DERIVATIVE; ISONIAZID; MACROLIDE; MUCOLYTIC AGENT; NARCOTIC ANALGESIC AGENT; PARACETAMOL; PENICILLIN DERIVATIVE; SULFONAMIDE; THIAZIDE DIURETIC AGENT; TRIMETHOPRIM DERIVATIVE; TUMOR NECROSIS FACTOR ALPHA INHIBITOR; UNINDEXED DRUG; VALPROIC ACID;

ARTICLE; DATA MINING; DISEASE ASSOCIATION; DRUG CLASSIFICATION; DRUG SAFETY; HUMAN; LIVER TOXICITY; POLYPHARMACY; PRIORITY JOURNAL; RISK ASSESSMENT; TOXIC HEPATITIS; CHEMICAL AND DRUG INDUCED LIVER INJURY; DRUG INTERACTION; DRUG SURVEILLANCE PROGRAM; FACTUAL DATABASE; STATISTICS AND NUMERICAL DATA; WORLD HEALTH ORGANIZATION;

ACETAMINOPHEN; ADVERSE DRUG REACTION REPORTING SYSTEMS; AMOXICILLIN-POTASSIUM CLAVULANATE COMBINATION; CHEMICAL AND DRUG INDUCED LIVER INJURY; DATA MINING; DATABASES, FACTUAL; DRUG INTERACTIONS; ISONIAZID; VALPROIC ACID; WORLD HEALTH ORGANIZATION;

EID: 84930630272     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2015.05.004     Document Type: Article

References (79)

1. Aleo M.D., et al. Human drug-induced liver injury severity is highly associated with dual inhibition of liver mitochondrial function and bile salt export pump. Hepatology 2014, 60(3):1015-1022.
2. Alisi A., et al. Thyroid status affects rat liver regeneration after partial hepatectomy by regulating cell cycle and apoptosis. Cell. Physiol. Biochem. 2005, 15(1-4):69-76.
3. Almenoff J.S., et al. Disproportionality analysis using empirical Bayes data mining: a tool for the evaluation of drug interactions in the post-marketing setting. Pharmacoepidemiol. Drug Saf. 2003, 12(6):517-521.
4. Almenoff J., et al. Perspectives on the use of data mining in pharmaco-vigilance. Drug Saf. 2005, 28(11):981-1007.
5. Argikar U.A., Remmel R.P. Effect of aging on glucuronidation of valproic acid in human liver microsomes and the role of UDP-glucuronosyltransferase UGT1A4, UGT1A8, and UGT1A10. Drug Metab. Dispos. 2009, 37(1):229-236.
6. Bjornsson E., Olsson R. Suspected drug-induced liver fatalities reported to the WHO database. Dig. Liver Dis. 2006, 38(1):33-38.
7. Carayon P., et al. Involvement of peripheral benzodiazepine receptors in the protection of hematopoietic cells against oxygen radical damage. Blood 1996, 87(8):3170-3178.
8. Carey E.J., et al. Inpatient admissions for drug-induced liver injury: results from a single center. Dig. Dis. Sci. 2008, 53(7):1977-1982.
9. Caster O., et al. Methylprednisolone-induced hepatotoxicity: experiences from global adverse drug reaction surveillance. Eur. J. Clin. Pharmacol. 2014, 70(4):501-503.
10. Chalasani N.P., et al. ACG Clinical Guideline: the diagnosis and management of idiosyncratic drug-induced liver injury. Am. J. Gastroenterol. 2014, 109(7):950-966. quiz 967.
11. Chen M., et al. A testing strategy to predict risk for drug-induced liver injury in humans using high-content screen assays and the 'rule-of-two' model. Arch. Toxicol. 2014, 88(7):1439-1449.
12. Cheng X., et al. Regulation of hepatic bile acid transporters Ntcp and Bsep expression. Biochem. Pharmacol. 2007, 74(11):1665-1676.
13. Cheung C.K., et al. Use of complementary and alternative therapies in community-dwelling older adults. J. Altern. Complement. Med. 2007, 13(9):997-1006.
14. Cullen J.M., et al. Time course gene expression using laser capture microscopy-extracted bile ducts, but not hepatic parenchyma, reveals acute alpha-naphthylisothiocyanate toxicity. Toxicol. Pathol. 2010, 38(5):715-729.
15. Davit-Spraul A., et al. The spectrum of liver diseases related to ABCB4 gene mutations: pathophysiology and clinical aspects. Semin. Liver Dis. 2010, 30(2):134-146.
16. de Abajo F.J., et al. Acute and clinically relevant drug-induced liver injury: a population based case-control study. Br. J. Clin. Pharmacol. 2004, 58(1):71-80.
17. Dictionary, 2014. World Health Organization, Anatomical Therapeutic Chemical Classification.
18. DuMouchel W. Bayesian data mining in large frequency tables, with an application to the FDA Spontaneous Reporting System (with discussion). Am. Stat. 1999, 53:177-202.
19. DuMouchel, W., P.D., 2001. Empirical Bayes Screening for Multi-item Associations the Seventh ACM SIGKDD International Conference on Knowledge Discovery and Data Mining San Francisco, California Association for Computing Machinery.
20. DuMouchel, W., 2007. A new family of link functions extending logistic regression Joint Statistical Meetings, Salt Lake City, July 30, 2007 (Invited presentation).
21. Estes J.D., et al. High prevalence of potentially hepatotoxic herbal supplement use in patients with fulminant hepatic failure. Arch. Surg. 2003, 138(8):852-858.
22. Felix K., et al. The antioxidative activity of the mucoregulatory agents: ambroxol, bromhexine and N-acetyl-l-cysteine. A pulse radiolysis study. Life Sci. 1996, 59(14):1141-1147.
23. Fontana R.J., et al. Idiosyncratic drug-induced liver injury is associated with substantial morbidity and mortality within 6 months from onset. Gastroenterology 2014, 147(1):96-108. e104.
24. Garcia-Pagan J.C., et al. Nicardipine increases hepatic blood flow and the hepatic clearance of indocyanine green in patients with cirrhosis. J. Hepatol. 1994, 20(6):792-796.
25. Gurwitz J.H., et al. Incidence and preventability of adverse drug events among older persons in the ambulatory setting. JAMA 2003, 289(9):1107-1116.
26. Han D., et al. Regulation of drug-induced liver injury by signal transduction pathways: critical role of mitochondria. Trends Pharmacol. Sci. 2013, 34(4):243-253.
27. Hauben M. A brief primer on automated signal detection. Ann. Pharmacother. 2003, 37(7-8):1117-1123.
28. Huang R.F., et al. Folate depletion and elevated plasma homocysteine promote oxidative stress in rat livers. J. Nutr. 2001, 131(1):33-38.
29. Hubner C., et al. Sodium, hydrogen exchange type 1 and bile ductular secretory activity in the guinea pig. Hepatology 2000, 31(3):562-571.
30. Indiana University Division of Clinical Pharmacology P450 Drug Interaction Table, 2015. Available at: <> (accessed 09.02.15). http://medicine.iupui.edu/clinpharm/ddis/main-table/.
31. James R.C., et al. Phenylpropanolamine potentiation of acetaminophen-induced hepatotoxicity: evidence for a glutathione-dependent mechanism. Toxicol. Appl. Pharmacol. 1993, 118(2):159-168.
32. Jolley C.D., et al. Induction of bile acid synthesis by cholesterol and cholestyramine feeding is unimpaired in mice deficient in apolipoprotein AI. Hepatology 2000, 32(6):1309-1316.
33. Kacevska M., et al. Perspectives on epigenetics and its relevance to adverse drug reactions. Clin. Pharmacol. Ther. 2011, 89(6):902-907.
34. Kohane I.S. Using electronic health records to drive discovery in disease genomics. Nat. Rev. Genet. 2011, 12(6):417-428.
35. Kozlov A.V., et al. Effect of estrogen on mitochondrial function and intracellular stress markers in rat liver and kidney following trauma-hemorrhagic shock and prolonged hypotension. Mol. Med. 2010, 16(7-8):254-261.
36. Kunduzova O.R., et al. Involvement of peripheral benzodiazepine receptor in the oxidative stress, death-signaling pathways, and renal injury induced by ischemia-reperfusion. J. Am. Soc. Nephrol. 2004, 15(8):2152-2160.
37. Lammert C., et al. Relationship between daily dose of oral medications and idiosyncratic drug-induced liver injury: search for signals. Hepatology 2008, 47(6):2003-2009.
38. Law V., et al. DrugBank 4.0: shedding new light on drug metabolism. Nucleic Acids Res. 2014, 42(D1):D1091-D1097.
39. Leitzmann M.F., et al. Thiazide diuretics and the risk of gallbladder disease requiring surgery in women. Arch. Intern. Med. 2005, 165(5):567-573.
40. Lu J., et al. Amiodarone exposure during modest inflammation induces idiosyncrasy-like liver injury in rats: role of tumor necrosis factor-alpha. Toxicol. Sci. 2012, 125(1):126-133.
41. Lucena M.I., et al. Determinants of the clinical expression of amoxicillin-clavulanate hepatotoxicity: a prospective series from Spain. Hepatology 2006, 44(4):850-856.
42. Lucena M.Isabel, et al. Susceptibility to amoxicillin-clavulanate-induced liver injury is influenced by multiple HLA class I and II alleles. Gastroenterology 2011, 141(1):338-347.
43. Maes M. The immunoregulatory effects of antidepressants. Hum. Psychopharmacol. 2001, 16(1):95-103.
44. McWhirter D., et al. Chemotherapy induced hepatotoxicity in metastatic colorectal cancer: a review of mechanisms and outcomes. Crit. Rev. Oncol. Hematol. 2013, 88(2):404-415.
45. Moore T.J., et al. Serious adverse drug events reported to the Food and Drug Administration, 1998-2005. Arch. Intern. Med. 2007, 167(16):1752-1759.
46. Morgan R.E., et al. Interference with bile salt export pump function is a susceptibility factor for human liver injury in drug development. Toxicol. Sci. 2010, 118(2):485-500.
47. Morgan R.E., et al. A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development. Toxicol. Sci. 2013, 136(1):216-241.
48. Murata K., et al. A novel mechanism for drug-induced liver failure: inhibition of histone acetylation by hydralazine derivatives. J. Hepatol. 2007, 46(2):322-329.
49. Navarro V.J., et al. Liver injury from herbals and dietary supplements in the U.S. Drug-Induced Liver Injury Network. Hepatology 2014, 60(4):1399-1408.
50. Oben J.A., et al. Sympathetic nervous system inhibition increases hepatic progenitors and reduces liver injury. Hepatology 2003, 38(3):664-673.
51. Okamoto T., et al. Histamine H1-receptor antagonists with immunomodulating activities: potential use for modulating T helper type 1 (Th1)/Th2 cytokine imbalance and inflammatory responses in allergic diseases. Clin. Exp. Immunol. 2009, 157(1):27-34.
52. Perez M.J., Briz O. Bile-acid-induced cell injury and protection. World J. Gastroenterol. 2009, 15(14):1677-1689.
53. Pessayre D., et al. Central role of mitochondria in drug-induced liver injury. Drug Metab. Rev. 2012, 44(1):34-87.
54. Peterson P.K., et al. The opioid-cytokine connection. J. Neuroimmunol. 1998, 83(1-2):63-69.
55. Pirmohamed M., et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ 2004, 329(7456):15-19.
56. Poirier L.A., Wise C.K. On the chemical causation of methyl deficiency and its attendant pathologies. Regul. Res. Perspect. 2003, 3:1-31.
57. Qato D.M., et al. Use of prescription and over-the-counter medications and dietary supplements among older adults in the United States. JAMA 2008, 300(24):2867-2878.
58. Ramirez E., et al. Proton pump inhibitors are associated with hypersensitivity reactions to drugs in hospitalized patients: a nested case-control in a retrospective cohort study. Clin. Exp. Allergy 2013, 43(3):344-352.
59. Randall L.H., et al. Cholelithiasis in infants receiving furosemide: a prospective study of the incidence and one-year follow-up. J. Perinatol. 1992, 12(2):107-111.
60. Reuben A., et al. Drug-induced acute liver failure: results of a U.S. multicenter, prospective study. Hepatology 2010, 52(6):2065-2076.
61. Romanque P., et al. Thyroid hormone administration induces rat liver nrf2 activation: suppression by N-acetylcysteine pretreatment. Thyroid 2011, 21(6):655-662.
62. Roy S., Loh H.H. Effects of opioids on the immune system. Neurochem. Res. 1996, 21(11):1375-1386.
63. Sakatis M.Z., et al. Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds. Chem. Res. Toxicol. 2012, 25(10):2067-2082.
64. Senior J.R. Drug hepatotoxicity from a regulatory perspective. Clin. Liver Dis. 2007, 11(3):507-524. vi.
65. Sgro C., et al. Incidence of drug-induced hepatic injuries: a French population-based study. Hepatology 2002, 36(2):451-455.
66. Shimizu I., Ito S. Protection of estrogens against the progression of chronic liver disease. Hepatol. Res. 2007, 37(4):239-247.
67. Stieger B., et al. Drug- and estrogen-induced cholestasis through inhibition of the hepatocellular bile salt export pump (Bsep) of rat liver. Gastroenterology 2000, 118(2):422-430.
68. Suzuki A., et al. Co-medication with adrenoreceptor antagonists is associated with lower MELD scores at admission in patients with acetaminophen-induced acute liver failure. Gastroenterology 2009, 136(5 (Suppl. 1)):A-810.
69. Suzuki A., et al. Co-medications modulating liver injury and repair influence clinical outcome of acetaminophen-associated liver injury. Clin. Gastroenterol. Hepatol. 2009, 7(8):882-888.
70. Suzuki A., et al. Drugs associated with hepatotoxicity and their reporting frequency of liver adverse events in VigiBase: unified list based on international collaborative work. Drug Saf. 2010, 33(6):503-522.
71. Takikawa H., et al. Drug-induced liver injury in Japan: an analysis of 1676 cases between 1997 and 2006. Hepatol. Res. 2009, 39(5):427-431.
72. Tatonetti N.P., et al. Detecting drug interactions from adverse-event reports: interaction between paroxetine and pravastatin increases blood glucose levels. Clin. Pharmacol. Ther. 2011, 90(1):133-142.
73. Uetrecht J., Naisbitt D.J. Idiosyncratic adverse drug reactions: current concepts. Pharmacol. Rev. 2013, 65(2):779-808.
74. Vacca G., et al. Inhibition of granulocyte migration by tiotropium bromide. Respir. Res. 2011, 12:24.
75. Wang W., et al. Fenoterol, a beta(2)-adrenoceptor agonist, inhibits LPS-induced membrane-bound CD14, TLR4/CD14 complex, and inflammatory cytokines production through beta-arrestin-2 in THP-1 cell line. Acta Pharmacol. Sin. 2009, 30(11):1522-1528.
76. Watkins Paul B., et al. Aminotransferase elevations in healthy adults receiving 4 grams of acetaminophen daily: a randomized controlled trial. JAMA 2006, 296(1):87-93.
77. Yazici C., et al. Risk factors for severe or fatal drug-induced liver injury from amoxicillin-clavulanic acid. Hepatol. Res. 2014, 10.1111/hepr.12410.
78. Yu K., Geng X., Chen M., Zhang J., Wang B., Ilic K., Tong W. High daily dose and being a substrate of cytochrome P450 enzymes are two important predictors of drug-induced liver injury. Drug Metab. Dispos. 2014, 42(4):744-750.
79. Zimmerman H.J. Vulnerability of the liver to toxic injury. Chapter 3 in Hepatotoxicity: The Adverse Effects of Drugs and Other Chemicals on the Liver 1999, Lippincott Williams and Wilkins, Philadelphia, PA, USA. 2nd ed.