Comparing risk estimates of sulphonamide-induced agranulocytosis from the Swedish drug monitoring system and a case-control study

A comparison has been made of risk estimates for agranulocytosis connected with sulphasalazine and trimethoprim-sulphamethoxazole (T-SM) therapy calculated from data in the Swedish Drug Monitoring System ("spontaneous" reports, sales and prescription information) and a population based cas...

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Bibliographic Details
Published in:European journal of clinical pharmacology 1992-09, Vol.43 (3), p.211-214
Main Authors: KEISU, M, EKMAN, E, WIHOLM, B.-E
Format: Article
Language:English
Subjects:
Adolescent
Adult
Aged
Agranulocytosis - chemically induced
Agranulocytosis - physiopathology
Biological and medical sciences
Case-Control Studies
Drug Monitoring
Drug toxicity and drugs side effects treatment
Female
Humans
Male
Medical sciences
Middle Aged
Pharmacology. Drug treatments
Risk
Sulfasalazine - adverse effects
Sweden
Toxicity: blood
Trimethoprim, Sulfamethoxazole Drug Combination - adverse effects
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Summary:A comparison has been made of risk estimates for agranulocytosis connected with sulphasalazine and trimethoprim-sulphamethoxazole (T-SM) therapy calculated from data in the Swedish Drug Monitoring System ("spontaneous" reports, sales and prescription information) and a population based case-control study (the IAAAS). The relative risk for agranulocytosis during sulphasalazine treatment was calculated to be 107 and 123 by the spontaneous reporting system and the case-control study, respectively. The corresponding excess risk in both systems was 1.8. For T-SM the relative risk was 17 in the spontaneous reporting system and 12 in the case-control study, while the excess risk calculated for 3 days of treatment was 0.9 in the spontaneous reporting system, and 1.6 for 3 or more days of treatment in the case-control study. It is concluded that the Swedish Drug Monitoring System gives an appropriate estimate of the risk of developing agranulocytosis in association with the two drugs studied.
ISSN:0031-6970
1432-1041
DOI:10.1007/BF02333011