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Clinical Impact of Adverse Event Reporting


  1. Hayes PE, Kristoff CA. Adverse reactions to five new antidepressants. Clin Pharm 1986;5:471-480

  2. Kinney JL. Nomifensine maleate: a new second-generation antidepressant. Clin Pharm 1985;4:625-636

  3. Nomifensine withdrawn by manufacturer. FDA Drug Bull 1986;16:7-8

  4. Hoechst-Roussel Pharmaceuticals Inc.. Withdrawal of Merital. Somerville, NJ: Hoechst-Roussel Pharmaceuticals Inc., January 1986

  5. Mamelok RD. Drug discovery and development. In: Melmon KL, Morrelli HF, Hoffman BB, Nierenberg DW, eds. Melmon and Morrelli's Clinical Pharmacology: Basic Principles in Therapeutics. 3rd ed. New York: McGraw-Hill, Inc; 1992:911-921

  6. Venning GR. Identification of adverse reactions to new drugs. II--how were 18 important adverse reactions discovered and with what delays? Br Med J 1983;286:289-292

  7. Wallender M-A. The way towards adverse event monitoring in clinical trials. Drug Saf 1993;8:251-262

  8. Reeves PR, McCormick DJ, Jepson HT. Practolol metabolism in various small animal species. Xenobiotica 1979;9:453-458

  9. Rosenbaum SE, Lindup WE, Orton TC. Practolol and its metabolites: tissue localization and retention in the hamster. J Pharmacol Exp Ther 1985;234:485-490

  10. MedWatch Continuing Education Article. Clinical therapeutics and the recognition of drug-induced disease. Goldman SA, Kennedy DL, Lieberman RL, eds. Rockville, Md: Food and Drug Administration, June 1995

  11. Lewis JA. Post-marketing surveillance: how many patients? Trends Pharmacol Sci 1981;2:93-94

  12. Kessler DA. Introducing MedWatch: a new approach to reporting medication and device adverse effects and product problems. JAMA 1993;269:2765-2768

  13. American Medical Association. Reporting adverse drug and medical device events: report of the AMA's Council on Ethical and Judicial Affairs. Food and Drug Law Journal 1994;49:359-366

  14. Advisory Opinion No. 1 to Section 4-A, Devices and Therapeutic Methods, of the American Dental Association Principles of Ethics and Code of Professional Conduct

  15. The Journal of the American Medical Association. JAMA instructions for authors. JAMA 1996;275:5-12

  16. Chen RT, Rastogi SC, Mullen JR, Hayes SW, Cochi SL, Donlon JA, et al. The Vaccine Adverse Event Reporting System (VAERS). Vaccine 1994;12:542-550

  17. The National Childhood Vaccine Injury Act of 1986, at Section 2125 of the Public Health Service Act as codified at 42 U.S.C. 300aa-25(Suppl 1987)

  18. 21 CFR 803 and 807

  19. Protecting the identities of reporters of adverse events and patients; preemption of disclosure rules. Fed Regist 1995; 60(April 3);16962-16968

  20. Joint Commission on Accreditation of Healthcare Organizations. 1996 Comprehensive Accreditation Manual for Hospitals. Oakbrook Terrace, IL: Joint Commission on Accreditation of Healthcare Organizations, 1995

  21. ASHP guidelines on adverse drug reaction monitoring and reporting. Am J Health Syst Pharm 1995;52:417-419

  22. 21 CFR 314.80

  23. 21 CFR 600.80

  24. Dietary Supplement Health and Education Act (DSHEA) of 1994

  25. Faich GA. Adverse-drug-reaction monitoring. N Engl J Med 1986;314:1589-1592

  26. Koch-Weser J, Sellers EM, Zacest R. The ambiguity of adverse drug reactions. Eur J Clin Pharmacol 1977;11:75-78

  27. Green DM. Pre-existing conditions, placebo reactions, and "side effects". Ann Intern Med 1964;60:255-265

  28. Reidenberg MM, Lowenthal DT. Adverse nondrug reactions. N Engl J Med 1968;279:678-679

  29. Karch FE, Smith CL, Kerzner B, Mazzullo JM, Weintraub M, Lasagna L. Adverse drug reactions - a matter of opinion. Clin Pharmacol Ther 1976;19:489-492

  30. Rawlins MD. Pharmacovigilance: paradise lost, regained or postponed? The William Withering Lecture 1994. J R Coll Physicians Lond 1995;29:41-49

  31. Strom BL, Tugwell P. Pharmacoepidemiology: current status, prospects, and problems. Ann Intern Med 1990;113:179-181

  32. Scott HD, Rosenbaum SE, Waters WJ, Colt AM, Andrews LG, Juergens JP, et al. Rhode Island physicians' recognition and reporting of adverse drug reactions. R I Med J 1987;70:311-316

  33. Sachs RM, Bortnichak EA. An evaluation of spontaneous adverse drug reaction monitoring systems. Am J Med 1986;81(suppl 5B):49-55

  34. Weber JCP. Epidemiology of adverse reactions to nonsteroidal antiinflammatory drugs. In: Rainsford KD, Velo GP, eds. Advances in Inflammation Research. Vol 6. New York: Raven Press; 1984:1-7

  35. Begaud B, Moride Y, Tubert-Bitter P, Chaslerie A, Haramburu F. False-positives in spontaneous reporting: should we worry about them? Br J Clin Pharmacol 1994;38:401-404

  36. Serradell J, Bjornson DC, Hartzema AG. Drug utilization study methodologies: national and international perspectives. Drug Intell Clin Pharm 1987;21:994-1001

  37. Fletcher AP. Spontaneous adverse drug reaction reporting vs event monitoring: a comparison. J R Soc Med 1991;84:341-344

  38. Finney DJ. The detection of adverse reactions to therapeutic drugs. Stat Med 1982;1:153-161

  39. Finney DJ. Statistical aspects of monitoring for dangers in drug therapy. Methods Inf Med 1971;10:1-8

  40. Standardization of definitions and criteria of causality assessment of adverse drug reactions: drug-induced liver disorders: report of an international consensus meeting. Int J Clin Pharmacol Ther Toxicol 1990;28:317-322

  41. Auriche M, Loupi E. Does proof of causality ever exist in pharmacovigilance? Drug Saf 1993;9:230-235

  42. Temple RJ, Jones JK, Crout JR. Adverse effects of newly marketed drugs. N Engl J Med 1979;300:1046-1047

  43. Rossi AC, Knapp DE. Discovery of new adverse drug reactions: a review of the Food and Drug Administration's Spontaneous Reporting System. JAMA1984;252:1030-1033

  44. Turner WM, Milstien JB, Faich GA, Armstrong GD. The processing of adverse event reports at FDA. Drug Information Journal 1986;20:147-150

  45. Sekul EA, Cupler EJ, Dalakas MC. Aseptic meningitis associated with high-dose intravenous immunoglobulin therapy: frequency and risk factors. Ann Intern Med 1994;121:259-262

  46. Scribner CL, Kapit RM, Phillips ET, Rickles NM. Aseptic meningitis and intravenous immunoglobulin therapy. Ann Intern Med 1994;121:305-306

  47. Feczko PJ, Simms SM, Bakirci N. Fatal hypersensitivity reaction during a barium enema. AJR Am J Roentgenol 1989; 153:275-276

  48. Ownby DR, Tomlanovich M, Sammons N, McCullough J. Anaphylaxis associated with latex allergy during barium enema examinations. AJR Am J Roentgenol 1991;156:903-908

  49. Hertzman, PA. L-trytophan related eosinophilia-myalgia syndrome. In: Drug and Device Induced Disease: Developing a Blueprint for the Future." Proceedings of a MedWatch Conference 1994 Jan 21-22; Washington, DC. Rockville, Md: Food and Drug Administration, 1994

  50. Love LA, Rader JI, Crofford LJ, Raybourne RB, Principato MA, Page SW, et al. Pathological and immunological effects of ingesting L-tryptophan and 1,1'-ethylidenebis (L-tryptophan) in Lewis rats. J Clin Invest 1993;91:804-811

  51. Farinelli S, Mariani A, Grimaldi A, Mariani M, Iannessi A, De Rosa F. [Eosinophilia-myalgia syndrome associated with 5-OH-tryptophan. Description of a case]. Recenti Prog Med 1991;82:381-384

  52. Lampert A, Joly P, Thomine E, Ortoli JC, Lauret P. [Scleroderma-like syndrome with bullous morphea during treatment with 5-hydroxytryptophan, carbidopa and flunitrazepam]. Ann Dermatol Venereol 1992;119:209-211

  53. Flockhart DA, Clauw DJ, Sale EB, Hewett J, Woosley RL. Pharmacogenetic characteristics of the eosinophilia-myalgia syndrome. Clin Pharmacol Ther 1994;56:398-405

  54. Okada S, Sullivan EA, Kamb ML, Philen RM, Miller FW, Love LA. Human leukocyte antigen (HLA) DRB1 alleles define risk factors for the development of eosinophilia myalgia syndrome (EMS) [abstract]. Arthritis Rheum 1994;37(Suppl):S274

  55. Blum MD, Graham DJ, McCloskey CA. Temafloxacin syndrome: review of 95 cases. Clin Infect Dis 1994;18:946-950

  56. Sobel S. The role of epidemiology in the regulation of oral contraceptives. Public Health Rep 1984;99:350-354

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The MedWatch program would like to thank Mary W. Brady, R.N., M.S.N., Suzanne E. Rich, R.N., and Marie H. Reid, R.N., B.S.N (CDRH) for their contributions to the medical device clinical synopsis. In addition, the editorial contributions of Vincent F. Guinee, M.D., M.P.H. and Robert C. Nelson, Ph.D.(CDER) are gratefully acknowledged.

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