Abstract
Before a new drug is allowed on the market it has been thoroughly tested, first in animals and later in healthy volunteers and in patients. Thus, most of its positive effects and the more common adverse effects are known. However, because of the inherent limitations in premarketing testing with regard to population size and composition, and the limited number of long-term studies available, the full profile of positive and negative effects of a new drug cannot be known prior to marketing. It is therefore of utmost importance that new drugs be continuously monitored for new effects. The objective of postmarketing surveillance (PMS) is therefore to make inferences about new drug-related effects; traditionally PMS studies focus on adverse effects.
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References
G.R. Venning, Identifications of adverse reactions to new drugs, II-How were 18 important adverse reactions discovered and with what delay?, BMJ. 286:289–292 (1983).
B-E. Wiholm, Spontaneous reporting outside the USA, in: “Pharmacoepidemiology,” B. Strom, ed., Churchville Livingstone, New York, 119–134 (1989).
I.R. Edwards, M. Lindquist, B-E Wiholm, and E. Napke, Quality criteria for early signals of possible adverse drug reactions, Lancet. II:156–58 (1990).
The International Agranulocytosis and Aplastic Anemia Study: Risk of agranulocytosis and aplastic anemia, A first report of their relation to drugs with special reference ta analgesics, JAMA. 256:1749–57 (1986).
C. Bénichou, and G. Danan, Criteria of drug-induced liver disorders. Report of an international consensus meeting, J Hepatol. (1990).
Diagnostic cnterions for Guillain-Barré, National Institute for Neurological and Communicative Disorders and Stroke (NINCDS), JAMA. 249:1709–10 (1978).
G. Danan, Consensus meetings on causality assessment of drug-induced liver injury, J Hepatol. 7:132–36 (1988).
B. Beermann, G. Björck, and M. Groschinsky-Grind, Admissions to a medical clinic due to drugs and intoxications, Läkartidningen. 75:959–960 (1978).
U. Bergman, and B-E Wiholm, Drug-Related Problems Causing Admission to a Medical Clinic, Eur J Clin Pharmacol. 20:193–200 (1981).
K.J. Rothman, Causal inference in epidemiology, in: “Modern epidemiology,” Boston, Little, Brown and Company, pp. 7-21 (1986).
J. Carlson and B-E Wiholm, Trimethoprim associated aseptic meningitis, Scand J Infect Dis. 19:687–691 (1987).
Nordic Council on Medicines, Drug Monitoring in the Nordic Countries, An evaluation of simimlarities and differences, NLN Publication No. 25, Nordic Council on Medicines, Uppsala, Sweden.
R. van Leeuwen, and R.H.B. Meyboom, Agranulocytosis and aprinidine, Lancet. 11:1137 (1976).
Nordic Statistics on Medicines 1975–1977, Part II. Nordic Council on Medicines, Box 607, S-751 25 Uppsala, Sweden.
Statistisk sammanställning 1979–88 (Swedish Drug Statistics), “Introduction and codes in English,” National Corporation of Swedish Pharmacies, S-105 14, Stockholm, Sweden.
B-E Wiholm, Spontaneous reporting of ADR. in: “Detection and prevention of adverse drug reactions,” Skandia International Symposia, Almqvist & Wiksell Stockholm, p. 152-167 (1983).
M. Böttiger, V. Romanus, C. deVerdier, and G. Boman, Osteitis and other complications caused by generalized BCG-itis, Experiences in Sweden, Acta Pediat Scand. 71:471–478 (1982).
K. Asplund, and B-E Wiholm, Glibenclamide-associated hypoglycemia, a report on 57 cases, Diabetologia 24:412–417 (1983).
H. Jick, D. Slone, B. Westerholm, W.H.W. Inman, M.P. Vessey, S. Shapiro, G.P. Lewis, and J. Worcester, Venous thromboembolic disease and ABO blood type, Lancet. 1:539–542 (1969).
I. Strandberg, G. Boman, L. Hassler, and F. Sjöqvist, Acetylaltor phenotype in patients with hydralazine-induced lupoid syndrome, Acta Med Scand. 200:267–371 (1976).
J.R. Idle, The various criteria in establishing polymorphism of drug oxidation, in: Workshop on polymorphism of drug oxidation in man, (Oct 11–12, 1980, Bonn).
B-E Wiholm, G. Alvan, L. Bertilsson, and et. al., Hydroxylation of Debrisoquine in Patients with Lactic Acidosis after Phenformin, Lancet. pp. 1099 (1981).
J. Fagius, P.O. Osterman, Å. Siden, and B-E Wiholm, Guillain-Barré Syndrome following zimeldine treatment, J Neurol Neurosurg Psychiatry. 48:65–69 (1985).
F.T. Fraunfelder, M.S. Meyer, G.C. Bagby Jr., and M.N. Dreis, Hematologic reactions to carbonic anhydrase inhibitors, Am J Ophtalmol. 100:79–81 (1985).
M. Keisu, B-E Wiholm, Å. Öst, Ö. Mortimer, Acetazolamide associated Aplastic Anemia, J Intern Med. (in press).
The International Agranulocytosis and Aplastic Anemia Study: Incidence of aplastic anemia, The relevance of diagnostic criteria, Blood. 70:1718–1721.
L.E. Böttiger, and B. Westerholm, Drug-induced blood-dyscrasias in Sweden, Br Med J. 3:339–343 (1973).
P. Hörnsten P. M. Keisu, and B-E Wiholm, The Incidence of Agranulocytosis During Treatment of Dermatitis Herpetiformis With Dapsone as Reported in Sweden 1972–1988, Arch Dermatol. 26:919–922 (1990).
M. Keisu, and E. Ekman, Sulfasalazine associated agranulocytosis in Sweden 1972–1989, Clinical features, and estimation of its incidence, European J Clin Pharmacol. (in press).
J.L. Carson, B.L. Strom, K.A. Soper, S.L. West, M.L. Morse, The association of nonsteroidal anti-inflammatory drugs with upper gastrointestinal tract bleeding, Arch Intern Med. 147:1054–9 (1987).
M. Keisu, E. Ekman, and B-E Wiholm, Comparing risk estimates of sulfa induced agranulocytosis from the Swedish Drug Monitoring System and a case-control study, Eur J Clin Pharmacol, (in press).
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Wiholm, BE. (1992). Postmarketing Surveillance of ADRs by Spontaneous Reporting and Register Data: The Swedish Approach. In: Strom, B.L., Velo, G. (eds) Drug Epidemiology and Post-Marketing Surveillance. NATO ASI Series, vol 224. Springer, Boston, MA. https://doi.org/10.1007/978-1-4899-2587-9_2
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DOI: https://doi.org/10.1007/978-1-4899-2587-9_2
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