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Comparing risk estimates of sulphonamide-induced agranulocytosis from the Swedish Drug Monitoring System and a case-control study

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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 1.5. 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.

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Authors and Affiliations

  1. Section of Pharmacoepidemiology Medical Products Agency, Uppsala, Sweden

    M. Keisu, E. Ekman & B. E. Wiholm

  2. Department of Clinical Pharmacology of the Karolinska Institute, Huddinge University Hospital, S-14186, Huddinge, Sweden

    M. Keisu & B. E. Wiholm

Authors
  1. M. Keisu
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  2. E. Ekman
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  3. B. E. Wiholm
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Keisu, M., Ekman, E. & Wiholm, B.E. Comparing risk estimates of sulphonamide-induced agranulocytosis from the Swedish Drug Monitoring System and a case-control study. Eur J Clin Pharmacol 43, 211–214 (1992). https://doi.org/10.1007/BF02333011

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  • DOI: https://doi.org/10.1007/BF02333011

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