A population based case-cohort study of drug-induced anaphylaxis

Abstract

1. In order to determine the risk of anaphylaxis as an adverse reaction to drugs, a case-cohort study was performed. Cases consisted of all admissions in 1987 and 1988 to all Dutch hospitals with anaphylaxis as the principal diagnosis, and a random sample of admissions with related symptoms. Hospital discharge summaries were classified according to probability to anaphylaxis by a blinded Audit Committee. Of admissions classified as probable or possible anaphylaxis, the causative agent was assessed. The reference cohort consisted of all persons in the catchment area of a sample of pharmacies in The Netherlands, in the period between January 1, 1987 and December 31, 1988. 2. Out of 934 admissions, discharge summaries on 811 admissions were received, of which 727 contained enough clinical details. Out of 727, 391 were classified as probable or possible anaphylaxis. In 336 of these 391, anaphylaxis was reason for admission. This group consisted of 158 men and 178 women. Drug-induced anaphylaxis occurred in 107 patients. 3. Drug-induced anaphylaxis was most frequently caused by penicillins, analgesics and non-steroidal antiinflammatory drugs (NSAID) with the highest point estimate of the risk relative to all other drugs of 10.7, 6.9 and 3.7 respectively. 4. In the cases of probable anaphylaxis, the risk of anaphylaxis to glafenine relative to all other drugs was 167.7 in 1987 (95%-CI: 63.0-446.4) and 128.6 in 1988 (95%-CI: 50.4-328.5), to amoxycillin 15.2 in 1987 (95%-CI: 5.0-46.0) and 4.4 in 1988 (95%-CI: 1.03-18.9) and to diclofenac 6.1 in 1988 (95%-CI: 1.4-26.1).(ABSTRACT TRUNCATED AT 250 WORDS)