Knowledge Park at Penn State Erie, Building 4 | 5340 Fryling Road, Suite 205 Erie, PA 16510
Ph: (814) 899-2001 | Fax: (814) 899-2002

Testing and Treatment Safety

Direct Allergy understands the concerns of physicians considering adding allergy testing and treatment to their practice.

Medical objects

Allergy testing and Immunotherapy have been around since 1911 and have benefited many patients since their discovery. Direct Allergy utilizes the Modified Quantitative Testing (MQT) Protocol, which blends skin-prick and Intradermal Testing (IDT) into a single, simple, safe testing method [1]. Direct Allergy brings almost 40 years of clinical expertise and oversight to the field of allergy testing and treatment.

A report from the Mayo Clinic on 79,593 Immunotherapy injections over a 10-year period showed the incidence of adverse reactions to be less than two-tenths of one percent (0.137 percent). Most of the reactions were mild and responded to immediate medical treatment. There were no fatalities [2]. More than one million injections were given without a fatality to 8,706 patients in allergy clinics at Roosevelt Hospital in New York City between 1935 and 1955 [3].

Rare occurrences of fatal anaphylactic episodes related to Immunotherapy are reported and studied. A total of 35 deaths following Immunotherapy administration were reported for the years 1985 through 1993. It has been estimated that during that period there were 52.3 million Immunotherapy procedures, making the incidence of fatality less than one per million (0.6692 per million) [4]. Data recently compiled by the Allergen Products Manufacturers Association (APMA) estimated the incidence of fatalities to be about three per 190 million annual injections, or approximately one per 63 million injections [5].

Another study evaluating 13 international fatalities related to Immunotherapy between 1992 and 1996 identified an elevated risk for patients with active asthma who are being switched to high doses [6]. For perspective, it is useful to compare these statistics with the incidence of fatalities related to other kinds of injections. Studies of fatal anaphylaxis reactions to injected penicillin have ranged from 0.4 fatalities per million injections [7] to one fatality per 7.5 million injections [8]. Fatalities related to radiocontrast “dyes” used in intravascular radiologic studies in the early 1980s varied from one in 13,000 procedures [9] to one in 75,000 procedures [10]. A more recent study showed a substantial improvement to about one fatality in 169,000 procedures [11].

Many of the antigen manufacturers have a large number of clients who are primary care physicians, and they’ve organized medical societies dedicated solely to the training of primary care physicians in the field of allergy. The key to safety is training and oversight. 

Direct Allergy provides physician and nurse training through its national nurse trainer. The nurses go through comprehensive training protocol. Periodic reviews are conducted by Direct Allergy’s nurse trainer. Utilizing the MQT testing protocol, combined with a safety test for each vial, the potential for adverse reactions is greatly diminished. The nurses are highly trained to be aware of patients who may not be suitable candidates for testing and treatment. Direct Allergy clients always have access to clinical oversight should the need arise. We provide a partnership that helps you safely manage the allergy patients in your practice.

[1] Quantitative Skin Testing for Allergy : IDT and MQT, Marple and Mabry, August 2006

[2] Valyaservi MA, Yocum MW, Gosselin VA, Hunt LW. Systemic reactions to immunotherapy at the Mayo Clinic. J Allergy Clin Immunol 1997; 99:S66.

[3] Van Arsdel PP, Sherman WB. The risk of inducing constitutional reactions in allergic patients. J Allergy 1957; 28:251-261.

[4] Turkeltaub P. Deaths associated with allergenic extracts. FDA Medical Bulletin 24, May 1994.

[5] Data on file with the Allergen Products Manufacturers Association. April 1997 Communication.

[6] Kordash T, Miller J. Allergenic extracts used in immunotherapy fatalities. J Allergy Clin Immunol 1997; 99:S67.

[7] Orange RP, Donsky GJ. Anaphylaxis. In Middleton E, Reed CE, Ellis EF, editors. Allergy: principles and practice. St. Louis 1978, Mosby.

[8] Idsoe O, Gruthe T, Wilcox RR, et al. Nature and extent of penicillin side-reactions with particular references to fatalities from anaphylactic shock. Bull WHO 1968; 38:159.

[9] Shehadi WH. Death following intravascular administration. Acta Radiol Diagn (Stockh). 1985 Jul-Aug;26(4):457-61.

[10] Hartman GW, Hattery RR, Witten DM, Williamson B. Mortality during excretory urography: Mayo Clinic Experience. AJR 1982; 139:919-922.

[11] Katayama H, Yamaguchi K, Kozuka T, et al. Reactions to ionic and nonionic contrast media: A report from the Japanese Committee on the Safety of Contrast Media. Radiology 1990; 175:621-628.