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Comment & Response |

Risk of Anaphylaxis With Intravenous Iron Products

Cunlin Wang, MD, PhD1; Sarah Wong, MPH2; David J. Graham, MD, MPH1
[+] Author Affiliations
1Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland
2ACUMEN LLC, Burlingame, California
JAMA. 2016;315(20):2232-2233. doi:10.1001/jama.2016.0965.
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In Reply In response to Dr DeLoughery’s concern about diphenhydramine, provided is a sensitivity analysis that excluded all anaphylaxis cases with the claim of “injection of diphenhydramine” (Table 1). Results are consistent with the primary analysis.

Table 1. Risk of Anaphylaxis Without Diphenhydramine at First Administration for New Intravenous Iron Product UsersIntravenous IronIron SucroseFerumoxytolIron DextranIron Gluconate2003-2013No. of anaphylaxis cases269121No. of new users264 166247 50094 400Rate per 100 000 persons (95% CI)9.8 (6.6-14.6)36.8 (29.8-45.4)22.2 (14.1-34.6)Adjusted OR (95% CI)a1 [Reference]3.6 (2.2-6.0)2.2 (1.2-4.2)P valueb<.001.012010 to 2013No. of anaphylaxis cases1217349No. of new users134 83682 11777 93534 029Rate per 100 000 persons (95% CI)8.9 (4.8-16.0)20.7 (12.5-33.9)43.6 (30.7-61.7)26.4 (12.9-52.2)Adjusted OR (95% CI)a1 [Reference]2.4 (1.0-5.7)4.8 (2.2-10.8)2.9 (1.0-8.3)P valueb.06<.001.04

Abbreviation: OR, odds ratio.

aAdjusted for age, indication, coronary heart disease, and hypertension.

bP value adjusted for multiple comparisons.


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May 24, 2016
Thomas G. DeLoughery, MD, MACP, FAWM
1Division of Hematology/Medical Oncology, Oregon Health Sciences University, Portland
JAMA. 2016;315(20):2232. doi:10.1001/jama.2016.0962.
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