Background: The Committee on Allergen Standardization of the American Academy of Allergy and Immunology (AAAI) began a study of fatalities associated with skin testing and immunotherapy in an effort to identify risk factors and to ascertain whether any additional precautions are required to prevent and treat serious reactions.
Methods: Questionnaire data was obtained from members of the AAAI and the American College of Allergy and Immunology, regarding 17 fatalities associated with immunotherapy for the years 1985 to 1989. In this period, no fatalities were reported with skin testing. The mean age of patients who died was 36.0 years (range: 10 to 77 years), and 69% were female. Of the patients who died, 76% had asthma, and most were reported to have had factors associated with severity (i.e., lability, required steroids, and/or prior hospitalizations). The only patient who had rhinitis alone had cardiovascular disease and was receiving a beta-blocker. High sensitivity by skin test or RAST was reported by 71%, and 36% reported prior systemic reactions. Sixty-five percent of the patients were undergoing build-up therapy. Fatalities involved use of allergen doses between 1:1 million to 1:10 wt/vol. Other factors associated with fatalities were: changing to a new vial of extract, 5; dosing error or inappropriate dose adjustment, 5; allergen season, 5; symptomatic before injection, 4; not waiting after injection, 2; and home injection, 1. Onset of anaphylaxis occurred within 20 minutes in eleven patients, within 20 to 30 minutes in one, and after more than 30 minutes in one. In eleven cases the cause of death was associated with respiratory compromise. These data reinforce the need for special precautions in treating high-risk patients with asthma. The annual fatality rate from administration of allergenic extracts in the United States remains very low: 1 fatality per 2 million doses, but additional educational efforts to further reduce the fatality rate are needed.