Abstract
Several constituencies are interested in the safety of drugs, and therefore in the discovery of adverse effects and in valid estimates of their incidence, which are the main objectives of drug surveillance. The constituencies include government regulatory agencies, pharmaceutical manufacturers, academic scientists and the medical community at large, and the public.
This is a preview of subscription content, log in via an institution to check access.
Preview
Unable to display preview. Download preview PDF.
References
Anonymous (1980) Ticrynafen recalled. FDA Drug Bull 10:3–4
Borden EK, Lee JG (1982) A methodologie study of postmarketing drug evaluation using a pharmacy-based approach. J Chron Dis 35: 803–816
Colin-Jones DG, Langman MJS, Lawson DH, Vessey MP (1985) Postmarketing surveillance of the safety of cimetidine: mortality during second, third, and fourth years of follow-up. Br Med J 291:1084–1088
Committee of Principal Investigators (1978) A co-operative trial in the primary prevention of ischaemic heart disease using cloflbrate. Br Heart J 40:1069–1118
Edmondson HA, Henderson B, Benton B (1976) Liver cell adenomas associated with use of oral contraceptives. N Engl J Med 294:470–472
Friedman GD, Ury HK (1980) Initial screening for carcinogenicity of commonly used drugs. JNCI 1980; 65
Herbst AL, Ulfelder H, Poskanzer DC (1971) Adenocarcinoma of the vagina. Association of maternal stilbestrol therapy with tumor appearance in young women. N Engl J Med 284: 878–881
Inman WHW (1984) P & M news 2:4–10
International Agranulocytosis and Aplastic Anemia Study (1983) The design of a study of the drug etiology of agranulocytosis and aplastic anemia. Eur J Clin Pharmacol 24: 833–836
Jick H, Walter AM, Rothman KJ et al. (1981) Vaginal spermicides and congenital disorders. JAMA 245:1329–1332
Kaufman DW, Miller DR, Rosenberg L, Heimlich SP, Stolley PD, Schottenfeld D, Shapiro S (1984) Noncontraceptive estrogen use and the risk of breast cancer. JAMA 252: 63–67
Kay CR (1977) Oral contraceptives — the clinical perspective. In: Garattini S, Berendes HW (eds) Pharmacology of steroid contraceptive drugs. Raven, New York, pp 1–24
Levy M (1974) Aspirin use in patients with major upper gastrointestinal bleeding and peptic ulcer disease. N Engl J Med 290:1158
Louik C, Lacouture PG, Mitchell AA, Kaufman R, Lovejoy FH, Shapiro S (1985) A study of adverse reaction algorithms in a drug surveillance program. Clin Pharmacol Ther 38:183–187
Mitchell AA, Rosenberg L, Shapiro S, Slone D (1981) Birth defects related to use of Bendectin in pregnancy. 1. Oral clefts and cardiac defects. JAMA 245: 22, 2311–2314
Mitchell AA, Schwingl PJ, Rosenberg L, Louik C, Shapiro S (1983) Birth defects in relation to Bendectin use in pregnancy. 2. Pyloric stenosis. Am J Obstet Gynecol 147:737–742
Rosenberg L, Shapiro S, Slone D, Kaufman DW, Heimlich SP, Mietinen OS, Stolley PD, Rosenshein NB, Schottenfeld D, Engle RL (1982) Epithelial ovarian cancer and the use of combination oral contraceptives. JAMA 247: 3210–3212
Rosenberg L, Miller DR, Kaufman DW, Heimlich SP, Stolley PD, Schottenfeld D, Shapiro S (1984) Breast cancer and oral contraceptive use. Am J Epidemiol 119:167–176
Royal College of General Practitioners (1974) Oral contraceptives and health. Pitman, New York
Sartwell P (1974) Retrospective studies. Ann Intern Med 81: 381–386
Shapiro S, Slone D, Rosenberg L, Kaufman DW, Stolley PD, Miettinen OS (1979) Oral contraceptive use in relation to myocardial infarction. Lancet 1: 743–746
Shapiro S, Parsells JL, Rosenberg L, Kaufman DW, Helmrich SP, Rosenshein N, Lewis J, Rnapp R, Stolley PD, Schottenfeld D (1985) Risk of localized and widespread endometrial cancer in relation to recent and discontinued use of conjugated estrogens. N Engl J Med 313:968–972
Slone D, Shapiro S, Miettinen OS (1977) Case-control surveillance of serious illnesses attributable to ambulatory drug use. In: Columbo F, Shapiro S, Slone D, Tognoni G (eds) Epidemiological evaluation of drugs. Littleton, Mass. PSG, pp 59–74
Stampfer MJ, Willett WC, Colditz GA, Rosner B, Speizer FE, Hennekens CH (1985) A prospective study of postmenopausal estrogen therapy and coronary heart disease. N Engl J Med 313: 1044–1049
Strom BL, Carson JL, Morse MML, LeRoy AA (1985) The computerized on-line Medicaid pharmaceutical analysis and surveillance system: a new resource for postmarketing drug surveillance. Clin Pharmacol Ther 38:359–364
University Group Diabetes Program (1970) A study of the effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes. Diabetes 19 [Suppl 2]: 747–830
Vessey MP (1976) A long-term follow-up of women using different methods of contraception: an interim report. J Biosoc Sci 8:373–427
Weiss NS, Sayvetz TA (1980) Incidence of endometrial cancer in relation to the use of oral contraceptives. N Engl J Med 302: 551–554
World Health Organization. International agency for Research on Cancer (LARC) (1977) Some miscellaneous pharmaceutical substances. Monographs on the evaluation of carcinogenic risk of chemicals to man 13:131–138
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 1987 Springer-Verlag Berlin, Heidelberg
About this paper
Cite this paper
Shapiro, S. (1987). Reasons for the Successes and Failures of Specific Models in Drug Epidemiology. In: Kewitz, H., Roots, I., Voigt, K. (eds) Epidemiological Concepts in Clinical Pharmacology. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-71043-8_3
Download citation
DOI: https://doi.org/10.1007/978-3-642-71043-8_3
Publisher Name: Springer, Berlin, Heidelberg
Print ISBN: 978-3-642-71045-2
Online ISBN: 978-3-642-71043-8
eBook Packages: Springer Book Archive