Allergic histories and reactions of patients treated with digoxin immune Fab (ovine) antibody. The Digibind Study...

Seven hundred seventeen adult patients with life-threatening digitalis intoxication were treated with Fab fragments of ovine antidigoxin immunoglobulin G (IgG). Results of the efficacy of treatment and adverse effects were collected with standard report forms. Eighty-two (11%) of the patients were recorded as having histories of allergy (71 patients) and/or asthma (11 patients). Of the "allergic" subjects, 35 described reactions to antibiotics, 19 to other medications, 3 to foods, and 2 to pollens; in 12 subjects the etiologic agent was not specified. Six subjects had adverse reactions that were probably or possibly due to allergy to components of the antibody preparation. Of these 4 (5%; 95% confidence interval (Cl) 1.8% to 12%) occurred in the 82 subjects with histories of allergy or asthma and 3 (9%; 95% Cl 1.8% to 23%) of these occurred in the 35 persons with histories of allergy to an antibiotic. In contrast, only 2 (0.3%; 95% Cl 0.04% to 1.1%) similar reactions occurred in the 635 subjects with no histories of allergy or asthma. All reactions responded to symptomatic treatment. The authors conclude that treatment of digitalis intoxication with ovine antidigoxin IgG-Fab (Digibind) is generally well tolerated and allergic reactions are rare. However, there is a significantly increased risk of reactions in patients with histories of allergy or asthma.