Drug-induced anaphylaxis in spontaneous adverse drug reaction
reports
B. Sachs1,2, D. Schichler1,2, S. Riegel1, S. Erdmann2 and
H. F. Merk2
1Bundesinstitut fu¨r Arzneimittel und Medizinprodukte, Abteilung
Pharmakovigilanz, Bonn, Germany;
2Klinik fu¨r Allergologie und Dermatologie, RWTH Aachen,
Aachen, Germany

Background: Drug-induced anaphylaxis is a maximal variant of a
(pseudo-) allergic immediate-type reaction. In Germany, numerous
cases of suspected adverse drug reactions (ADRs) are reported
spontaneously to the Federal Institute for Drugs and Medical
Devices (BfArM) and registered in a large ADR database. The
aim of the present study was to analyze cases of drug-induced
anaphylaxis reported to the BfArM with regard to the drugs
administered and basic epidemiological parameters.

Methods: All cases of anaphylaxis, anaphylactic shock,
anaphylactic/anaphylactoid reaction reported to the BfArM
between 1993 and March 2004 were identified and assessed with
regard to correctness of the diagnosis anaphylaxis and the causal
relationship with the drug according to international agreed criteria.
Further analyses were performed in defined subgroups. Estimations
of exposure with the various drugs were derived from published
utilization data.

Results: From 2239 cases reporting the aforementioned terms, 1144 were randomly extracted and analyzed in detail. The diagnosis
anaphylaxis and the causal relationship with the drug were
assessed as certain or probable in 386/1144 cases. Among these
386 anaphylaxis cases, 84 (22%) referred to antibiotics, 81 (21%)
to contrast media, 45 (12%) to non-steroidal anti-inflammatory
drugs, 36 (9%) to anti-neoplastics, and 24 (6%) to analgesics.
Among the antibiotics, 52/84 cases (62%) referred to quinolones,
and this was not matched by a comparable large estimation of
exposure.

Conclusions: In our investigation, most anaphylaxis cases were
confined to drug groups which have also been described in
literature as being frequently associated with such reactions.
Quinolones accounted for a relevant number of anaphylaxis cases
among the group of antibiotics.