Safety of dextran in relation to other colloids--ten years experience with hapten inhibition.

OBJECTIVE

The effects of hapten inhibition with dextran 1 (molecular weight: 1,000 D, Promit), which is in use since 1982 for the prevention of severe dextran-induced anaphylactic reactions (DIAR) caused by immune complexes, were studied.

DESIGN

Spontaneous reports to the manufacturer and to the WHO database INTDIS regarding adverse reactions to clinical dextran after preinjection of dextran 1 and to dextran 1 alone were collected from 1983 to 1992. During this period a total of 5.1 million doses of dextran 1 were sold in 15 countries.

INTERVENTIONS

Analysis of pre- and post-reaction titers of dextran-reactive antibodies (DRA) was made in most Scandinavian reports.

RESULTS

The incidence of severe DIAR (grades III-V) to clinical dextran after the prophylactic use of hapten inhibition was approximately 1/200,000 patients receiving dextran 1. In Sweden, where reporting of severe adverse drug reactions is mandatory, the incidence was approximately 1/70,000, indicating a 35-fold reduction. Only 2 fatal reactions were reported, an incidence of 1/2.5 million doses, indicating a 90-fold reduction. Both these occurred in patients with extremely high titers of DRA. Side effects to dextran 1, mostly mild, were reported in approximately 1 case per 100,000 doses. These side effects were not antibody mediated.

CONCLUSIONS

The above findings, together with other recent safety profile data, suggest that dextran with hapten inhibition has possibly become the safest plasma substitute in current clinical practice.