Skip to main content
SpringerLink
Log in

Adverse Drug Reactions

  • Chapter
Topics in Clinical Pharmacology and Therapeutics

Abstract

Until the mid-1960s, our knowledge of adverse drug effects in the clinical setting derived from two primary sources: 1) the known pharmacology of the drugs used, and 2) informal observations leading to anecdotal case histories reported to journals, government agencies, and other interested parties. For example, it was recognized that as a concomitant of their primary pharmacologic effect, anticoagulants were responsible for bleeding in some patients; that CNS-depressant drugs sometimes produced excessive respiratory depression, drowsiness, and even coma on occasion; and that insulin sometimes caused hypoglycemia. This knowledge was primarily qualitative because data providing the frequency of the clinical toxicity of the many drugs used in clinical practice were not available. Unanticipated serious toxicity of drugs was discovered after substantial clinical usage as anecdotal case reports accumulated.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
eBook
USD 16.99
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. Jick H, Miettinen OS, Shapiro S, Lewis GP, Siskind V, Slone D: Comprehensive drug surveillance. JAMA 213: 1455–1460, 1970.

    Article  PubMed  CAS  Google Scholar 

  2. Jick H, Walker AM, Spriet-Pourra C: Post-marketing follow-up. JAMA 242: 2310–2314, 1979.

    Article  PubMed  CAS  Google Scholar 

  3. Jick H, Madsen S, Nudelman PM, Perera DR, Stergachis A: Post-marketing follow-up at Group Health Cooperative of Puget Sound. Pharmacotherapy 4: 99–100, 1984.

    PubMed  CAS  Google Scholar 

  4. Jick H: The discovery of drug-induced illness. N Engl J Med 296: 481–485, 1977.

    Article  PubMed  CAS  Google Scholar 

  5. Jick H, Vessey MP: Case-control studies in the evaluation of drug-induced illness. Am J Epidemiol 107: 1–7, 1978.

    PubMed  CAS  Google Scholar 

  6. Miller RR: Drug surveillance utilizing epidemiologic methods. A report from the Boston Collaborative Drug Surveillance Program. Am J Hosp Pharm 30: 584–592, 1973.

    PubMed  CAS  Google Scholar 

  7. Jick H: Drugs—remarkably non-toxic. N Engl J Med 291: 824–828, 1974.

    Article  PubMed  CAS  Google Scholar 

  8. Cohen MR: A compilation of abstracts and an index of articles published by the Boston Collaborative Drug Surveillance Program. Hosp Pharm 12: 455–492, 1977.

    PubMed  CAS  Google Scholar 

  9. Lawson DH: Analgesic consumption and impaired renal function. J Chronic Dis 26: 39–45, 1973.

    Article  PubMed  CAS  Google Scholar 

  10. Boston Collaborative Drug Surveillance Program: Oral contraceptives and venous thromboembolic disease, surgically confirmed gallbladder disease, and breast tumours. Lancet 1: 1399–1404, 1973.

    Google Scholar 

  11. Boston Collaborative Drug Surveillance Program: Surgically confirmed gallbladder disease, venous thromboembolism and breast tumors in relation to postmenopausal estrogen therapy. N Engl J Med 290: 15–19, 1974.

    Article  Google Scholar 

  12. Boston Collaborative Drug Surveillance Program: Regular aspirin intake and acute myocardial infarction. Br Med J 1: 440–443, 1974.

    Article  Google Scholar 

  13. Boston Collaborative Drug Surveillance Program: Functional ovarian cysts and oral contraceptives; negative association confirmed surgically. JAMA 228: 68–69, 1974.

    Article  Google Scholar 

  14. Danielson DA, Porter JB, Dinan BJ, O’Connor PC, Lawson DH, Kellaway GSM, Jick H: Drug monitoring of surgical patients. JAMA 248: 1482–1485, 1982.

    Article  PubMed  CAS  Google Scholar 

  15. Slone D, Jick H, Lewis GP, Shapiro S, Miettinen OS: Intravenously given ethacrynic acid and gastrointestinal bleeding. A finding resulting from comprehensive drug surveillance. JAMA 209: 1668–1671, 1969.

    Article  PubMed  CAS  Google Scholar 

  16. Jick H, Porter J: Drug-induced gastrointestinal bleeding. Lancet 2: 87–89, 1978.

    Article  PubMed  CAS  Google Scholar 

  17. Arndt KA, Jick H: Rates of cutaneous drug reactions. A report from the Boston Collaborative Drug Surveillance Program. JAMA 235: 918–923, 1976.

    Article  PubMed  CAS  Google Scholar 

  18. Danielson DA, Porter JB, Lawson DH, Soubrie C, Jick H: Drug-associated psychiatric disturbances in medical inpatients. Psychopharmacology 74: 105–108, 1981.

    Article  PubMed  CAS  Google Scholar 

  19. Porter J, Jick H: Drug-induced anaphylaxis, convulsions, deafness, and extrapyramidal symptoms. Lancet 1: 587–588, 1977.

    Article  PubMed  CAS  Google Scholar 

  20. Boston Collaborative Drug Surveillance Program: Relation of body weight and insulin to the frequency of hypoglycemia. JAMA 228: 192–194, 1974.

    Article  Google Scholar 

  21. Boston Collaborative Drug Surveillance Program: Acute adverse reactions to prednisone in relation to dosage. Clin Pharmacol Ther 13: 694–698, 1972.

    Google Scholar 

  22. Miller RR: Hospital admissions due to adverse drug reactions: A report from the Boston Collaborative Drug Surveillance Program. Arch Intern Med 134: 219–223, 1974.

    Article  PubMed  CAS  Google Scholar 

  23. Porter J, Jick H: Drug-related deaths among medical inpatients. JAMA 237: 879–881, 1977.

    Article  PubMed  CAS  Google Scholar 

  24. Levy M: Aspirin use in patients with major upper gastrointestinal bleeding and peptic-ulcer disease: a report from the Boston Collaborative Drug Surveillance Program. N Engl J Med 290: 1158–1162, 1974.

    Article  PubMed  CAS  Google Scholar 

  25. Jick H, Slone D, Borda I, Shapiro S: Efficacy and toxicity of heparin in relation to age and sex. N Engl J Med 279: 284–286, 1968.

    Article  PubMed  CAS  Google Scholar 

  26. Shapiro S, Slone D, Siskind V, Lewis GP, Jick H: Drug rash with ampicillin and other penicillins. Lancet 2: 969–972, 1969.

    Article  PubMed  CAS  Google Scholar 

  27. Boston Collaborative Drug Surveillance Program: Clinical depression of the central nervous system due to diazepam and chlordiazepoxide in relation to cigarette smoking and age. N Engl J Med 288: 277–280, 1973.

    Article  Google Scholar 

  28. Greenblatt DJ, Koch-Weser J: Adverse reactions to spironolactone: a report from the Boston Collaborative Drug Surveillance Program. JAMA 225: 40–43, 1973.

    Article  PubMed  CAS  Google Scholar 

  29. Boston Collaborative Drug Surveillance Program: Diphenylhydantoin side effects and serum albumin levels. Clin Pharmacol Ther 14: 529–532, 1973.

    Google Scholar 

  30. Lewis GP, Jusko WJ, Burke CW, Graves L, Boston Collaborative Drug Surveillance Program: Prednisone side effects and serum protein levels. Lancet 2: 778–781, 1971.

    Article  PubMed  CAS  Google Scholar 

  31. Jick H, Slone D, Westerholm B, Inman WHW, Vessey MP, Shapiro S, Lewis GP, Worcester J: Venous thromboembolic disease and ABO blood type. A cooperative study. Lancet 1: 539–542, 1969.

    Article  PubMed  CAS  Google Scholar 

  32. Boston Collaborative Drug Surveillance Program: Relation between digoxin arrhythmias and ABO blood groups. Circulation 45: 352–357, 1972.

    Google Scholar 

  33. Jick H: Smoking and clinical drug effects. Med Clin North Am 58: 1143–1149, 1974.

    PubMed  CAS  Google Scholar 

  34. Jick H: Computer analysis of epidemiologic data about drug interactions in hospital patients. Drug Infor J January/June: 72–80, 1972.

    Google Scholar 

  35. Boston Collaborative Drug Surveillance Program: Interaction between chloral hydrate and warfarin. N Engl J Med 286: 53–55, 1972.

    Article  Google Scholar 

  36. Boston Collaborative Drug Surveillance Program: Excess of ampicillin rashes associated with allopurinol or hyperuricemia. N Engl J Med 286: 505–507, 1972.

    Article  Google Scholar 

  37. Boston Collaborative Drug Surveillance Program: Allopurinol and cytotoxic drugs: interaction in relation to bone marrow depression. JAMA 227: 1036–1040, 1974.

    Article  Google Scholar 

  38. Jick H, Watkins RN, Hunter JR, Dinan BJ, Madsen S, Rothman KJ, Walker AM: Replacement estrogens and endometrial cancer. N Engl J Med 300: 218–222, 1979.

    Article  PubMed  CAS  Google Scholar 

  39. Jick H, Walker AM, Watkins RN, D’Ewart DC, Hunter JR, Danford A, Madsen S, Dinan BJ, Rothman KJ: Oral contraceptives and breast cancer. Am J Epidemiol 112: 577–585, 1980.

    PubMed  CAS  Google Scholar 

  40. Jick H, Walker AM, Watkins RN, D’Ewart DC, Hunter JR, Danford A, Madsen S, Dinan BJ, Rothman KJ: Replacement estrogens and breast cancer. Am J Epidemiol 112: 586–594, 1980.

    PubMed  CAS  Google Scholar 

  41. Jick H, Walker AM, Rothman KJ, Hunter JR, Holmes LB, Watkins RN, D’Ewart DC, Danford A, Madsen S: Vaginal spermicides and congenital disorders. JAMA 245: 1329–1332, 1981.

    Article  PubMed  CAS  Google Scholar 

  42. Porter JB, Jick H, Dinan BJ: Acute cholecystitis and thiazides. N Engl J Med 304: 954–955, 1981.

    Article  PubMed  CAS  Google Scholar 

  43. Jick H, Holmes LB, Hunter JR, Madsen S, Stergachis A: First-trimester drug use and congenital disorders. JAMA 246: 343–346, 1981.

    Article  PubMed  CAS  Google Scholar 

  44. Lawson DH, Jick H, Hunter JR, Madsen S: Exoge¬nous estrogens and breast cancer. Am J Epidemiol 114: 710–713, 1981.

    PubMed  CAS  Google Scholar 

  45. O’Connor PC, Jick H, Hunter JR, Stergachis A, Madsen S: Propranolol and pregnancy outcome [Letter]. Lancet 2: 1168, 1981.

    Article  PubMed  Google Scholar 

  46. Jick H, Dinan BJ, Hunter JR, Madsen S, Stergachis A: Sedating drugs and automobile accidents leading to hospitalization. Am J Publ Health 71:1399–1400, 1981.

    Article  CAS  Google Scholar 

  47. Porter JB, Hunter JR, Danielson DA, Jick H, Stergachis A: Oral contraceptives and nonfatal vascular disease—recent experience. Obstet Gynecol 59: 299–302, 1982.

    PubMed  CAS  Google Scholar 

  48. Jick H, Dinan BJ, Hunter JR: Triamterene and renal stones. J Urol 127: 224–225, 1982.

    PubMed  CAS  Google Scholar 

  49. Danielson DA, Hannan MT, Jick H: Metronidazole and cancer [Letter]. JAMA 247: 2498–2499, 1982.

    Article  PubMed  CAS  Google Scholar 

  50. Jick H, Shiota K, Shepard TH, Hunter JR, Stergachis A, Madsen S, Porter JB: Vaginal spermicides and miscarriage seen primarily in the emergency room. Teratogen Carcinogen Mutagen 2: 205–210, 1982.

    Article  CAS  Google Scholar 

  51. Danielson DA, Jick H, Hunter JR, Stergachis A, Madsen S: Nonestrogenic drugs and breast cancer. Am J Epidemiol 116: 329–332, 1982.

    PubMed  CAS  Google Scholar 

  52. Jick H, Hannan MT, Stergachis A, Heidrich F, Perera DR, Rothman KJ: Vaginal spermicides and gonorrhea. JAMA 248: 1619–1621, 1982.

    Article  PubMed  CAS  Google Scholar 

  53. Jick H, Dinan BJ, Hunter JR, Stergachis A, Ronning A, Perera DR, Madsen S, Nudelman PM: Tricyclic antidepressants and convulsions. J Clin Psychopharmacol 3: 182–185, 1983.

    Article  PubMed  CAS  Google Scholar 

  54. Stergachis A, Perera DR, Schnell MM, Jick H: Antibiotic-associated colitis. West J Med 140: 217–219, 1984.

    PubMed  CAS  Google Scholar 

  55. Fox DA, Jick H: Nonsteroidal anti-inflammatory drugs and renal disease. JAMA 251: 1299–1300, 1984.

    Article  PubMed  CAS  Google Scholar 

  56. Danielson DA, Jick H, Perera DR, Porter JB, Hunter JR, Werrbach JH: Drug toxicity and hospitalization among lithium users. J Clin Psychopharmacol 4: 108–110, 1984.

    Article  PubMed  CAS  Google Scholar 

  57. Jick H, Aselton P, Hunter JR: Phenylpropanolomine and cerebral hemorrhage [Letter]. Lancet 1: 1017, 1984.

    Article  PubMed  CAS  Google Scholar 

  58. Aselton P, Jick H, Chentow SJ, Perera DR, Hunter JR, Rothman KJ: Pyloric stenosis and maternal Bendectin exposure. Am J Epidemiol 120: 251–256, 1984.

    PubMed  CAS  Google Scholar 

  59. Jick H, Aselton P, Habakangas JS: Benzodiazepine- induced convulsions [Letter]. Pharmacotherapy 4: 164, 1984.

    PubMed  Google Scholar 

  60. Jick H, Brandt DE: Allopurinol and cataracts. Am J Ophthalmol 98: 355–358, 1984.

    PubMed  CAS  Google Scholar 

  61. Jick SS, Jick H, Habakangas JS, Dinan BJ: Cotrimoxazole toxicity in children [Letter]. Lancet 2: 631, 1984.

    Article  PubMed  CAS  Google Scholar 

  62. Porter JB, Perera DR, Janeway CM, Stergachis A, Hunter JR, Jick H: Absence of a causal association between cimetidine and gastric cancer [Letter]. Gastroenterology (accepted for publication).

    Google Scholar 

  63. Porter JB, Jick H, Perera DR, Ylvisaker JT, Hunter JR: Long-term follow-up study of cimetidine. Pharmacotherapy (accepted for publication).

    Google Scholar 

  64. Danielson DA, Douglas SW III, Herog P, Jick H, Porter JB: Drug-induced blood disorders. JAMA (accepted for publication).

    Google Scholar 

  65. Jick H, Perera DR: Serious toxicity to allopurinol [Letter]. JAMA 252: 1411, 1984.

    Article  PubMed  CAS  Google Scholar 

  66. Perera DR, Seiffert AK, Greeley HM: Ibuprofen associated meningoencephalitis in a patient without collagen vascular disease. Ann Intern Med 100: 619, 1984.

    PubMed  CAS  Google Scholar 

Download references

Authors
  1. Hershel Jick
    View author publications

    You can also search for this author in PubMed Google Scholar

Editor information

Editors and Affiliations

  1. Clinical Pharmacology Section, University of Southern California, School of Medicine, Los Angeles, California, 90033, USA

    Robert F. Maronde (Professor of Medicine, Head) (Professor of Medicine, Head)

Rights and permissions

Reprints and permissions

Copyright information

© 1986 Springer-Verlag New York Inc.

About this chapter

Cite this chapter

Jick, H. (1986). Adverse Drug Reactions. In: Maronde, R.F. (eds) Topics in Clinical Pharmacology and Therapeutics. Springer, New York, NY. https://doi.org/10.1007/978-1-4612-4864-4_21

Download citation

  • DOI: https://doi.org/10.1007/978-1-4612-4864-4_21

  • Publisher Name: Springer, New York, NY

  • Print ISBN: 978-1-4612-9336-1

  • Online ISBN: 978-1-4612-4864-4

  • eBook Packages: Springer Book Archive

Publish with us

Policies and ethics

Search

Navigation