Associations of gender and age with the reporting of drug-induced hepatic failure: Data from the vigibase

Journal of Clinical Pharmacology

Volumn 53, Issue 4, 2013, Pages 435-443

  Petronijevic, Marija ^a   Ilic, Katarina ^b  

^a Medicines and Medical Devices Agency of Serbia   (Serbia)

^b UNIVERSITY OF BELGRADE   (Serbia)

Author keywords

Age; Drug induced hepatic failure; Gender; Spontaneous reporting

Indexed keywords

ABACAVIR; AMIODARONE; ANALGESIC AGENT; ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; ANTICONVULSIVE AGENT; ANTIDIABETIC AGENT; ANTIINFECTIVE AGENT; ANTIINFLAMMATORY AGENT; ANTINEOPLASTIC AGENT; ANTIRHEUMATIC AGENT; ANTIVIRUS AGENT; ATORVASTATIN; BETA1A INTERFERON; CENTRAL STIMULANT AGENT; CYCLOPHOSPHAMIDE; DIDANOSINE; EFAVIRENZ; INDINAVIR; LAMOTRIGINE; METHOTREXATE; NEVIRAPINE; PARACETAMOL; RIBAVIRIN; RITONAVIR; ROSIGLITAZONE; STAVUDINE; TENOFOVIR; TROGLITAZONE; UNINDEXED DRUG; VALPROIC ACID;

ADOLESCENT; ADULT; AGE DISTRIBUTION; AGED; ARTICLE; CHILD; COMORBIDITY; CORRELATION ANALYSIS; DATA BASE; DRUG CLASSIFICATION; DRUG SURVEILLANCE PROGRAM; DRUG UTILIZATION; FEMALE; GEOGRAPHIC DISTRIBUTION; HIGH RISK PATIENT; HUMAN; LIVER FAILURE; LIVER TOXICITY; MAJOR CLINICAL STUDY; MALE; POSTMARKETING SURVEILLANCE; RISK FACTOR; SEX DIFFERENCE; TOXIC HEPATITIS; WORLD HEALTH ORGANIZATION;

ADOLESCENT; ADULT; ADVERSE DRUG REACTION REPORTING SYSTEMS; AGE FACTORS; AGED; AGED, 80 AND OVER; CHILD; CHILD, PRESCHOOL; FEMALE; HUMANS; INFANT; INFANT, NEWBORN; LIVER FAILURE; MALE; MIDDLE AGED; PHARMACEUTICAL PREPARATIONS; SEX FACTORS; YOUNG ADULT;

EID: 84877846935     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1002/jcph.3     Document Type: Article

References (40)

1. Au JS, Navarro VJ, Rossi S. Review article: drug-induced liver injury-its pathophysiology and evolving diagnostic tools. Aliment Pharmacol Ther. 2011;34:11-20.
2. Abboud G, Kaplowitz N. Drug-induced liver injury. Drug Saf. 2007;30:277-294.
3. Bernal W, Auzinger G, Dhawan A, Wendon J. Acute liver failure. Lancet. 2010;376:190-201.
4. Ostapowicz G, Fontana RJ, Schiødt FV, et al. Results of a prospective study of acute liver failure at 17 tertiary care centers in the United States. Ann Intern Med. 2002;137:947-954.
5. Bernal W, Auzinger G, Wendon J. Prognostic utility of the bilirubin lactate and etiology score. Clin Gastroenterol Hepatol. 2009;7: 249.
6. Wei G, Bergquist A, Broomé U, et al. Acute liver failure in Sweden: etiology and outcome. J Intern Med. 2007;262:393-401.
7. Chalasani N, Björnsson E. Risk factors for idiosyncratic druginduced liver injury. Gastroenterology. 2010;138:2246-2259.
8. Russmann S, Kullak-Ublick GA, Grattagliano I. Current concepts of mechanisms in drug-induced hepatotoxicity. Curr Med Chem. 2009;16:3041-3053.
9. Reuben A, Koch DG, Lee WM, Acute Liver Failure Study Group. Drug-induced acute liver failure: results of a U.S. multicenter, prospective study. Hepatology. 2010;52:2065-2076.
10. Andrade RJ, Lucena MI, Fernández MC, et al. Drug-induced liver injury: an analysis of 461 incidences submitted to the Spanish registry over a 10-year period. Gastroenterology. 2005;129:512-521.
11. Lucena MI, Andrade RJ, Kaplowitz N, et al. Phenotypic characterization of idiosyncratic drug-induced liver injury: the influence of age and gender. Hepatology. 2009;49:2001-2009.
12. Danan G, Benichou C. Causality assessment of adverse reactions to drugs: I. A novel method based on the conclusions of international consensus meetings: application to drug-induced liver injuries. J Clin Epidemiol. 1993;46:1323-1330.
13. Lindquist M. VigiBase, the WHO Global ICSR Database System: basic facts. Drug Inf J. 2008;42:409-419.
14. WHO-ART-WHO Adverse Reaction Terminology. http://www. umc-products.com/DynPage.aspx? id73589&mn11107&mn21664 Accessed April 25, 2012.
15. WHO Collaborating Center for drugs statistics methodology. Anatomical Therapeutic Chemical (ATC) classification index including defined daily dose (DDDs) for plain substances. Oslo: World Health Organization Collaborating Center for Drug Statistics Methodology, 2005.
16. US Department of Health and Human Services. Centers for Disease Control and Prevention. National Center for Health Statistics. Health, United States, 2010: With Special Feature on Death and Dying. Hyattsville, MD. 2011. http://www.cdc.gov/nchs/data/hus/hus10.pdf#094 Accessed April 25, 2012.
17. Grimbert S, Fisch C, Deschamps D, et al. Effects of female sex hormones on mitochondria: possible role in acute fatty liver of pregnancy. Am J Physiol. 1995;268:G107-G115.
18. Fromenty B, Pessayre D. Inhibition of mitochondrial beta-oxidation as amechanism of hepatotoxicity. Pharmacol Ther. 1995;67:101-154.
19. Björnsson E, Jerlstad P, Bergqvist A, Olsson R. Fulminant druginduced hepatic failure leading to death or liver transplantation in Sweden. Scand J Gastroenterol. 2005;40:1095-1101.
20. Björnsson E, Olsson R. Outcome and prognostic markers in severe drug-induced liver disease. Hepatology. 2005;42:481-489.
21. Björnsson E, Olsson R. Suspected drug-induced liver fatalities reported to the WHO database. Dig Liver Dis. 2006;38:33-38.
22. Sgro C, Clinard F, Ouazir K, et al. Incidence of drug-induced hepatic injuries: a French population-based study. Hepatology. 2002;36: 451-455.
23. Lee WM. Drug-induced hepatotoxicity. N Engl J Med. 2003;349: 474-485.
24. Isacson D, Bingefors K. Epidemiology of analgesic use: a gender perspective. Eur J Anaesthesiol Suppl. 2002;26:5-15.
25. Larson AM, Polson J, Fontana RJ, et al. Acetaminophen-induced acute liver failure: results of a United States multicenter, prospective study. Hepatology. 2005;42:1364-1372.
26. Petronijevic M, Ilic K, Suzuki A. Drug induced hepatotoxicity: data from the Serbian pharmacovigilance database. Pharmacoepidemiol Drug Saf. 2011;20:416-423.
27. Hummer M, Kurz M, Kurzthaler I, Oberbauer H, Miller C, Fleischhacker WW. Hepatotoxicity of clozapine. J Clin Psychopharmacol. 1997;17:314-317.
28. Kuehner C. Gender differences in unipolar depression: an update of epidemiological findings and possible explanations. Acta Psychiatr Scand. 2003;108:163-174.
29. Bigos KL, Pollock BG, Stankevich BA, Bies RR. Sex differences in the pharmacokinetics and pharmacodynamics of antidepressants: an updated review. Gend Med. 2009;6:522-543.
30. Carey EJ, Vargas HE, Douglas DD, et al. Inpatient admissions for drug-induced liver injury: results from a single center. Dig Dis Sci. 2008;53:1977-1982.
31. Joint United Nations Programme on HIV/AIDS (UNAIDS). Unaids report on the global aids epidemic 2010. http://www.unaids.org/globalreport/documents/ 20101123-GlobalReport-full-en.pdf Accessed April 25, 2012.
32. Björnsson E. Hepatotoxicity associated with antiepileptic drugs. Acta Neurol Scand. 2008;118:281-290.
33. Björnsson E, Kalaitzakis E, Olsson R. The impact of eosinophilia and hepatic necrosis on prognosis in patients with druginduced liver injury. Aliment Pharmacol Ther. 2007;25:1411-1421.
34. Stewart JD, Horvath R, Baruffini E, et al. Polymerase g gene POLG determines the risk of sodium valproate-induced liver toxicity. Hepatology. 2010;52:1791-1796.
35. Kaplowitz N, DeLeve L. Drug-Induced Liver Disease. New York, NY: Informa; 2007.
36. Food and Drug Administration. Eulexin®: product information. http://www.accessdata.fda.gov/drugsatfda-docs/label/2001/18554/s23lbl.pdf Accessed April 25, 2012.
37. The Medicines and Healthcare products Regulatory Agency. Cyproterone acetate: summary of product characteristics. http://www.mhra.gov.uk/home/groups/ l-unit1/documents/websiteresources/con2023735.pdf Accessed April 25, 2012.
38. Nygaard B. Hyperthyroidism. Am Fam Physician. 2007;76:1014-1016.
39. Foxman B. The epidemiology of urinary tract infection. Nat Rev Urol. 2010;7:653-660.
40. Palumbo A, Anderson K. Multiple myeloma. N Engl J Med. 2011; 364:1046-1060.