Ziekenhuisopnamen in Nederland vanwege anafylaxie door glafenine, 1987-1988

Estimation of the risk of anaphylaxis to glafenine.

Design

A case cohort study.

Location

All general and university hospitals in the Netherlands.

Method

All admissions in 1987 and 1988 with anaphylaxis as the principal diagnosis, and a random sample of admissions with related symptoms were included. Hospital discharge summaries were classified according to probability of anaphylaxis by a blinded audit committee. Subsequently, of the cases of probable and 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 same period.

Results

Drug-induced anaphylaxis occurred in 107 patients: 20 were admitted because of anaphylaxis to glafenine (19), 12 to amoxicillin (11), 8 to diclofenac (7) and 7 to preparations containing paracetamol (7) of which 6 also contained propyphenazone (6). Relative risk estimations showed that the risk of developing 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) in the cases of probable anaphylaxis. Based on the number of prescriptions, the risk of developing anaphylaxis to glafenine was 16.8 relative to all penicillins (95 CI: 8.5-33.3) and 32.7 relative to all nonsteroidal anti-inflammatory drugs (95 CI: 16.9-63.0).

Conclusion

Based on the estimated incidence of anaphylaxis to penicillins of at least 1:10.000 prescriptions, the incidence of anaphylaxis to glafenine can be estimated at 1:1000 to 1:2000 prescriptions in the Netherlands.