Regulatory perspectives

Drug-Induced Liver Disease, Second Edition

Volumn , Issue , 2007, Pages 771-788

  Senior, John R ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

EID: 77958552519     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (54)

1. Senior JR. Regulatory perspectives. In: Kaplowitz N, DeLeve L, eds. Drug-Induced Liver Disease. 1st ed. New York: Marcel Dekker Inc., 2003 (Chap. 30).
2. Government Accountability Office. Drug safety: improvement needed in FDA’s postmarket decisionmaking and oversight process. GAO Report 06-402 to Congessional Requestors, March 2006; 1-62. (Accessed 28 July 2006 at http://www.gao.gov/new.items/d06402.pdf).
3. Institute of Medicine. Committee on Assessment of the U.S. Drug Safety System. (Accessed 28 July 2006 at http://www.iom.edu/drugsafety).
4. Drugs and the Liver: What They Do to Each Other. FDA/CDER teaching course, April 1999, University of Maryland Conference Center at Shady Grove, Gaithersburg, MD. (Accessed 28 July at http://www.fda.gov/cder/livertox/courses.pdf).
5. Task Force on Risk Management. Managing the risks from medical product use: creating a risk management framework. Report to the FDA Commissioner, May 1999. (Accessed 28 July at http://www.fda.gov/oc/tfrm/riskmanagement.pdf).
6. Drug-Induced Liver Injury: A National and Global Problem, 12-13 February 2001, Chantilly, VA. (Accessed 28 July at http://www.fda.gov/cder/livertox/default2001.htm).
7. HepTox Steering Group. 2007 Meeting, 24-5 January. (Accessed 25 April 2007 at http://www.fda. gov/cder/livertox).
8. Bissell DM, Gores GJ, Laskin DL, Hoofnagle JH. Drug-induced liver injury: mechanisms and test systems. Hepatology 2001; 33(4):1009-13.
9. Hoofnagle JH. Drug-induced liver injury network (DILIN). Hepatology 2004; 40(4):773.
10. www.fda.gov/cder/livertox
11. FDA. FY 2007 Budget Summary. All Purpose Tables 79-81. (Accessed 25 April 2007 at http://www.fda.gov/oc/oms/ofm/budget/2007/TOC.htm).
12. Adams CP, Brantner VV. Estimating the cost of new drug development: is it really 802 million dollars? Health Aff 2006; 25(2):420-8.
13. Office of the Federal Register. Part 312-Investigational New Drug Application. 21 Code of Federal Regulations. (Accessed 28 July 2006 at http://ecfr.gpoaccess.gov/; select Title 21, 300-499, 312).
14. Friedman LM, Furberg CD, DeMets DL. Fundamentals of Clinical Trials. 3rd ed. New York: Springer, 1998.
15. Office of the Federal Register. Part 314-Applications for FDA Approval to Market a New Drug. 21 Code of Federal Regulations. (Accessed 28 July 2006 at http://ecfr.gpoaccess.gov/; select Title 21, 300-499, 314).
16. Kaitin KI, Manoccchia M, Seibring M, Lasagna L. The new drug approvals of 1990, 1991, and 1992:trends in drug development. J Clin Pharmacol 1994; 34(2):120-7.
17. Kros JF, Qian J. Analysis of U.S. Food and Drug Administration review intervals for drugs approved during the period 1997-2002. Am J Ther 2004; 11(5):337-43.
18. CDER Report to the Nation: 2004. (Accessed 28 July 2006 at http://www.fda.gov/cder/reports/rtn/2004/rtn2004-1.htm).
19. FDA. New Requirements for Prescribing Information. (Accessed 28 July 2006 at http://www.fda. gov/cder/regulatory/physLabel/default.htm).
20. Handbook for Requesting Information and Records from FDA. (Accessed 28 July 2006 at http://www.fda.gov/opacom/backgrounders/foiahand.html).
21. FDA. Postmarketing Study Commitments. (Accessed 28 July 2006 at http://www.fda.gov/cder/pmc/default.htm).
22. FDA. Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products, 16 March 2004. (Accessed 28 July 2006 at http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html).
23. FDA. Mission Statement. (Accessed 28 July 2006 at http://www.fda.gov/opacom/morechoices/mission.html).
24. FDA. Critical Path Opportunities Report and List, March 2006. (Accessed 28 July 2006 at http://www.fda.gov/oc/initiatives/criticalpath/; Opportunities Report and List).
25. Ahmad SR. Adverse drug event monitoring at the Food and Drug Administration. J Gen Intern Med 2003; 18(1):57-60.
26. Begaud B, Martin K, Haramburu F, Moore N. Rates of spontaneous reporting of adverse drug reactions in France. JAMA 2002; 288(13):1588.
27. Gary MM, Harrison DJ. Analysis of severe adverse event related to use of mifepristone as an abortifacient. Ann Pharmacother 2006; 40(2):191-7.
28. Larson AM, Polson J, Fontana RJ, et al. Acetaminophen-induced acute liver failure: results of a United States multicenter, prospective study. Hepatology 2005; 42(6):1364-72.
29. Zimmerman HJ. Hepatotoxicity: The Adverse Effects of Drugs and Other Chemicals on the Liver. 2nd ed. Philadelphia: Lippincott Williams & Wilkins, 1999.
30. Davidson CS, Leevy CM, Chamberlayne EC, eds. Guidelines for detection of hepatotoxicity due to drugs and chemicals. Fogarty Conference, 1978, NIH Publication No. 79-313. Washington, DC: U.S. Government Printing Office, 1979.
31. Lewis JH. “Hy’s Law,” the “Rezulin Rule,” and other predictors of severe drug-induced hepatotoxicity:putting risk-benefit into perspective. Pharmacoepidemiol Drug Saf 2006; 15(4):221-9.
32. Kaplowitz N. Rules and laws of drug hepatotoxicty. Pharmacoepidemiol Drug Saf 2006; 15(4):231-3.
33. Senior JR. How can ‘Hy’ s law’ help the clinician? Pharmacoepidemiol Drug Saf 2006; 15(4):235-9.
34. Temple R. Predicting serious hepatotoxicity. Pharmacoepidemiol Drug Saf 2006; 15(4):241-3.
35. Nolan C, Goldberg SV, Buskin SE. Hepatotoxicity associated with isoniazid preventative therapy: a 7-year survey from a public health tuberculosis clinic. JAMA 1999; 281(11):1014-8.
36. Lee WM, Senior JR. Recognizing drug-induced liver injury: current problems, possible solutions. Toxicol Pathol 2005; 33(1):1155-64.
37. Temple R, Senior J. Clinical white paper. Drug-Induced Liver Injury: A National and Global Problem, 12-13 February 2001, Chantilly, VA. (Accessed 28 July at http://www.fda.gov/cder/livertox/clinical.pdf).
38. Mitchell JR, Long MW, Thorgeirsson UP, Jollow DJ. Acetylationrates and monthly liver function tests during one year of isoniazid preventative therapy. Chest 1975; 68(2):181-90.
39. Danan G. International consensus meeting. Criteria of drug-induced liver disorders. J Hepatol 1990; 11(2):272-6.
40. Neuberger J, Williams R. Halothane hepatitis. Dig Dis 1988; 6(1):52-64.
41. McKenzie R, Fried MW, Sallie R, et al. Hepatic failure and lactic acidosis due to fialuridine (FIAU), an investigational nucleoside analogue for chronic hepatitis B. N Engl J Med 1995; 333(17):1099-105.
42. Linnemann CJ, Jr., Shea L, Partin JC, Schubert WK, Schiff GM. Reye’s syndrome: epidemiologic and viral studies, 1963-1974. Am J Epidemiol 1975; 101(6):517-26.
43. Fontana RJ, Shakil AO, Greenson JK, Boyd I, Lee WM. Acute liver failure due to amoxicillin and amoxicillin/clavulanate. Dig Dis Sci 2005; 50(10):1785-90.
44. Seeff L. The problem of establishing causality. HepTox Steering Group. 2006 Meeting, North Bethesda, 25-26 January. (Accessed 28 July 2006 at http://www.fda.gov/cder/livertox/presentations2006/seeff.htm).
45. Danan G, Bénichou 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(11):1323-30.
46. Freston J. Use and limitations of the RUCAM. HepTox Steering Group. 2006 Meeting, North Bethesda, 25-26 January. (Accessed 28 July 2006 at http://www.fda.gov/cder/livertox/presentations2006/freston.htm).
47. Senior JR. Adaptation to liver injury: tacrine, isoniazid, ethanol, experimental drugs. HepTox Steering Group. 2006 Meeting, North Bethesda, 25-26 January. (Accessed 28 July 2006 at http://www.fda. gov/cder/livertox/presentations2006/senior.htm).
48. Mehendale H. Liver tissue repair, survival factors, and adaptation to injury. HepTox Steering Group. 2006 Meeting, North Bethesda, 25-26 January. (Accessed 28 July 2006 at http://www.fda.gov/cder/livertox/presentations2006/mehendale.htm).
49. Watkins PB. Insight into hepatotoxicity: the troglitazone experience. Hepatology 2005; 41(2):229-30.
50. Bilker WB, Berlin JA, Gail MH, Strom BL. An efficient design for verifying disease outcome status in large cohorts with rare exposures and low disease rates. Stat Med 1999; 18(22):3021-36.
51. Chan KA, Truman A, Gurwitz JH, et al. A cohort study o the incidence of serious acute liver injury in diabetic patients treated with hypoglycemic agents. Arch Int Med 2003; 163(6):728-34.
52. Drug- and toxicant-induced liver disease. In: Action Plan for Liver Disease Research (chap. 8), December 2004. (Accessed 28 July 2006 at http://www.niddk.nih.gov/fund/divisions/ddn/ldrb/ldrb_action_plan.htm).
53. Grassley C, Dodd C. Senators Introduce Bill to Establish New FDA Prescription Drug Safety Office, U.S.A. (Accessed 28 July 2006 at http://www.medicalnewstoday.com/medicalnews.php?newsidZ 23584).
54. Enzi M, Kennedy E. The Enhancing Drug Safety and Innovation Act of 2006. (Accessed 28 July 2006 at http://help.senate.gov/S_.pdf).