DRUG-ASSOCIATED ANAPHYLAXIS - 20 YEARS OF REPORTING IN THE NETHERLANDS (1974-1994) AND REVIEW OF THE LITERATURE

Background Since 1963, the Drug Safety Unit of the Dutch Inspectorate for Health Care (DSU) holds a voluntary reporting system. Objective To analyse all reports received in the years 1974 to 1994, registered as anaphylaxis or as a diagnosis that could contain cases of anaphylaxis . Methods All reports were classified as probable or possible anaphyla xis according to previously described criteria and the causal relation ship between exposure and anaphylaxis was assessed. Results Nine hundr ed and ninety-two reports possibly concerning anaphylaxis were receive d between 1974 and 1994. Fifty-six were unclassifiable. The remaining 936 reports concerned 326 men and 610 women. Three hundred and forty-f ive reports were classified as anaphylaxis probable, 485 as anaphylaxi s possible, and 106 as anaphylaxis unlikely by previously specified cr iteria. Drugs frequently associated with anaphylaxis (causal relations hip certain or probable) were: glafenine (326 reports classified as an aphylaxis probable or possible), combination preparations with (propy) phenazone or propyphenazone/phenacetine (39), diclofenac (30), dextran (20), ibuprofen (14), floctafenine (12), allergen extracts (12), sulf amethoxazole with trimethoprim (12), and trimethoprim (11). There is p robably substantial under-reporting as well as reporting bias in these data. Furthermore, many reports were classified as possible and not a s probable anaphylaxis because the temporal relationship was unknown o r not reported. Conclusion Drugs that caused anaphylaxis most frequent ly were glafenine, NSAID and certain antibiotics. Data from a voluntar y reporting system such as the DSU are valuable as an early warning sy stem for drugs that may induce anaphylactic reactions.