Postmarketing surveillance and adverse drug reactions current perspectives and future needs

JAMA

Volumn 281, Issue 9, 1999, Pages 824-829

  Brewer, Timothy ^a,c   Colditz, Graham A ^a,b  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^c CHANNING LABORATORY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL TRIAL; DATA BASE; DRUG SURVEILLANCE PROGRAM; EPIDEMIOLOGICAL DATA; HUMAN; INFORMATION PROCESSING; LONG TERM CARE; META ANALYSIS; METHODOLOGY; PRIORITY JOURNAL;

EID: 0033518849     PISSN: 00987484     EISSN: None     Source Type: Journal    
DOI: 10.1001/jama.281.9.824     Document Type: Article

References (50)

1. Lortie FM. Postmarketing surveillance of adverse drug reactions: problems and solutions CMAJ. 1986; 135:27-31.
2. Anello C, O'Neill RT. Does research synthesis have a place in drug regulatory policy? synopsis of issues: assessment of safety and postmarketing surveillance. Clin Res Reg Aff. 1996;13:13-21.
3. Sills JIM, Tanner A, Milstein JB. Food and Drug Administration monitoring of adverse drug reactions. Am J Hosp Pharm. 1986;43:2764-2770.
4. Frazier HS, Colditz GA. Oral contraceptives: postmarketing surveillance and rare, late complications of drugs. In: Frazier HS, Mosteller F, eds. Medicine Worth Paying For. Cambridge, Mass: Harvard University Press; 1995:212-219.
5. Enas GG, Goldstein DJ. Defining, monitoring and combining safety information in clinical trials. Stat Med. 1995;14:1099-1111.
6. Grodstein F, Stampfer MJ, Colditz GA, et al. Postmenopausal hormone therapy and mortality. N Engl J Med. 1997;336:1769-1775.
7. Hankinson SE, Colditz GA, Hunter DJ, Spencer TL, Rosner B, Stampfer MJ. A quantitative assessment of oral contraceptive use and risk of ovarian cancer. Obstet Gynecol. 1992;80:708-714.
8. Strom BL. Postmarketing surveillance and other epidemiologic uses of drug prescription data in the United States. Ann Ist Super Sanita. 1991;27:235-237.
9. Venning GR. Identification of adverse reactions to new drugs, IV: verification of suspected adverse reactions. BMJ. 1983;286:544-547.
10. Venulet J. Establishing requirements for the use of terms for reporting adverse drug reactions. Int J Clin Pharm Res. 1992;12:61-64.
11. Rossi AC, Knapp DE, Anello C, et al. Discovery of adverse drug reactions: a comparison of selected phase IV studies with spontaneous reporting methods. JAMA. 1983;249:2226-2228.
12. Kessler DA. Introducing MEDWATCH: a new approach to reporting medication and device adverse effects and product problems. JAMA. 1993;269:2765-2768.
13. White GG, LoveL. The MEDWATCHprogram. Clin Toxicol. 1998;36:145-149.
14. Piazza-Hepp TD, Kennedy DL. Reporting of adverse events to MEDWATCH. Am J Health Syst Pharm. 1995;52:1436-1439.
15. Scott HD, Thacher-Renshaw A, Rosenbaum SE, et al. Physician reporting of adverse drug reactions: results of the Rhode Island adverse drug reaction reporting project. JAMA. 1990;263:1785-1788.
16. Feely J, Moriarty S, O'Connor P. Stimulating reporting of adverse drug reactions by using a fee. BMJ. 1990;300:22-23.
17. Blum MD, Graham DJ, McCloskey CA. Temafloxacin syndrome: review of 95 cases. Clin Infect Dis. 1994;18:946-950.
18. Connolly HM, Crary IL, McGoon MD, et al. Valvular heart disease associated with fenfluramine-phentermine. N Engl J Med. 1997;337:581-588.
19. Graham DJ, Green L. Further cases of valvular heart disease associated with fenfluramine-phentermine. N Engl J Med. 1997;337:635.
20. Sanchez-Guerrero J, Colditz GA, Karlson EW, Hunter DJ, Speizer FE, Liang MH. Silicone breast implants and the risk of connective-tissue diseases and symptoms. N Engl J Med. 1995;332:1666-1670.
21. Case B, Oszko MA. Use of algorithm to evaluate published reports of adverse drug reactions. Am J Hosp Pharm. 1991;48:121-122.
22. Miremont G, Haramburu F, Bégaud B, Péré JC, Dangoumau J. Adverse drug reactions: physicians' opinions versus a causality assessment method. Eur J Clin Pharm. 1994;46:285-289.
23. Inman W, Pearce G. Prescriber profile and postmarketing surveillance. Lancet. 1993;342:658-661.
24. Mitchell AS, Henry DA, Sanson-Fisher IL, O'Connell DL. Patients as a direct source of information on adverse drug reactions. BMJ. 1988;297:891-893.
25. Classen DC, Pestotnik SL, Evans RS, Burke JP. Computerized surveillance of adverse drug events in hospital patients. JAMA. 1991;266:2847-2851.
26. Koch KE. Use of standardized screening procedures to identify adverse drug reactions. Am J Hosp Pharm. 1990;47:1314-1320.
27. Farrington P, Pugh S, Colville A, et al. A new method for active surveillance of adverse events from diphtheria/tetanus/pertussis and measles/mumps/ rubella vaccines. Lancet. 1995;345:567-569.
28. Ellenberg SS, Chen RT. The complicated task of monitoring vaccine safety. Public Health Rep. 1997; 112:10-20.
29. Chen RT. Active surveillance for vaccine adverse effects. Lancet. 1995;345:1369.
30. Chen RT, Rastogi SC, Mullen JR, et al. The Vaccine Adverse Reporting System (VAERS). Vaccine. 1994;12:542-550.
31. The West of Scotland Prevention Study Group. Computerized record linkage: compared with traditional patient follow-up methods in clinical trials and illustrated in a prospective epidemiological study. J Clin Epidemiol. 1995;48:1441-1452.
32. Colditz GA, Hankinson SE, Hunter DJ, et al. The use of estrogens and progestins and the risk of breast cancer in postmenopausal women. N Engl J Med. 1995; 332:1589-1593.
33. Pini LA, Sternieri E. Active reporting scheme: an example to evaluate specific adverse drug reactions Acta Physiol Hung. 1990;75(suppl):237-238.
34. Halvorsen KT, Burdick E, Colditz GA, Frazier HS, Mosteller F. Combining results from independent investigations: meta-analysis in clinical research. In: Bailar JC, Mosteller F, eds. Medical Use of Statistics. 2nd ed. Waltham, Mass: NEJM Books; 1992:413-426.
35. Lau J, Antman EM, Jimenez-Silva J, Kupelnick B, Mosteller F. Cumulative meta-analysis of therapeutic trials for myocardial infarction. N Engl J Med. 1992; 327:248-254.
36. Hine LK, Laird N, Hewitt P, Chalmers TC. Meta-analytic evidence against prophylactic use of lidocaine in acute myocardial infarction. Arch Intern Med. 1989;149:2694-2698.
37. Tuber P, Bégaud B, Péré JC, Haramburu F, Lellouch J. Power and weakness of spontaneous reporting: a probabilistic approach. J Clin Epidemiol. 1992; 45:283-286.
38. Wise RP, Kiminyo KP, Salive ME. Hair loss after routine immunizations. JAMA. 1997;278:1176-1178.
39. Brown RB, Klar J, Lemeshow S, Teres D, Pastides H, Sands M. Enhanced bleeding with cefoxitin or moxalactam: statistical analysis within a defined population of 1493 patients. Arch Intern Med. 1986;146: 2159-2164.
40. Labarthe DR. Methodologic variation in case-control studies of reserpine and breast cancer. J Chronic Dis. 1979;32:95-104.
41. Horwitz RI, Feinstein AR. Exclusion bias and the false relationship of reserpine and breast cancer. Arch Intern Med. 1985;145:1873-1875.
42. Nash JQ, Chandrakumar M, Farrington CP, Williamson S, Miller E. Feasibility study for identifying adverse events attributable to vaccination by record linkage. Epidemiol Infect. 1995;114:475-480.
43. Herbst AL, Ulfelder H, Poskanzer DC. Adenocarcinoma of the vagina: association of maternal stilbestrol therapy with tumor appearance in young women. N Engl J Med. 1971;284:878-881.
44. Senekjian EK, Potkul RK, Frey K, Herbst AL. Infertility among daughters either exposed or not exposed to diethylstilbestrol. Am J Obstet Gynecol. 1988; 158:493-498.
45. Stolley PD. The use of vital and mortality statistics for the detection of adverse drug reactions and for monitoring drug safety. J Clin Pharmacol. 1982; 22:499-504.
46. Capellà D, Laporte JR, Vidal X, et al. European network for the case-population surveillance of rare diseases (Euronet): a prospective feasibility study. Eur J Clin Pharmacol. 1998;53:299-302.
47. Auriche M, Loupi E. Does proof of casualty ever exist in pharmacovigilance? Drug Saf. 1993;9:230-235.
48. Heldenberg D, Harel S, Holtzman M, Levtow O, Tamir I. The effect of chronic anticonvulsant therapy on serum lipids and lipoproteins in epileptic children. Neurology. 1983;33:510-513.
49. Muuronen A, Kaste M, Nikkila EA, Tolppanen EM. Mortality from ischaemic heart disease among patients using anticonvulsive drugs: a case-control study. BMJ. 1985;291:1481-1483.
50. Eiris JM, Lojo S, Del Rio MC, et al. Effects of long-term treatment with antiepileptic drugs on serum lipid levels in children with epilepsy. Neurology. 1995;45: 1155-1157.