I-42

Anaphylactoid Reactions to Dextran 40 and 70: Reports to the US Food and Drug Administration (FDA), 1969-2004

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.

Methods:
We examined all adverse event reports to FDA with a CD as a suspect product. Probable anaphlaxis or anaphylactoid reactions (AAR) included anaphylactic signs or symptoms from at least 2 body systems, with at least one sign or symptom being hypotension, vasodilation, or respiratory difficulty, and onset within 60 minutes. Other reports were considered possible cases if the reporter specifically described the event as an AAR.

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.

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Last updated on 2006-MAR-27 by frf