C. E. Zinderman, L. Landow, R. P. Wise, CBER, FDA, Rockville, MD
Background:
Dextran 40 and 70, known as clinical dextrans (CDs), are widely used for postoperative thromboembolic prophylaxis. Severe anaphylactoid reactions caused by dextran-reactive IgG antibodies have been reported in 0.002 to 0.12% of CD patients. Dextran 1 pre-treatment significantly reduces this risk.
We estimated in-hospital use of CDs and dextran 1 in the US from 2000-2004 using discharge billing data from the Premier RxMarket Advisor sample of hospitals.
Results:
AARs accounted for 90 (24.6%) of the 366 adverse event reports for CDs received by FDA. Among 43 reports with time-to-onset information, all started within 60 minutes after infusion, and 26 (60.5%) began within 5 minutes. There were 15 deaths reported
The hospitalization ratio (which divides hospitalizations where a CD was administered by hospitalizations where dextran 1 was administered) was 28.4:1. The expected hospitalization ratio would be 1:1 if all CD recipients had received dextran 1 pre-treatment.
Conclusions:
Nearly ¼ of CD reports described AARs. Hospital discharge and product sales data in recent years suggest that few CD administrations have included dextran 1 pre-treatment.