The top medications reported to the FDA in association with anaphylaxis

Published online: September 26, 2020

Drug induced anaphylaxis is a well-known adverse drug reaction for some drug classes, in particular antibiotics such as penicillins, where recent progress has been made in optimizing testing and management strategies. Anaphylaxis is also a feared adverse drug reaction by patients and their treating providers due to its unpredictability and the potential for sudden severity and lethality. Outside of well-known drugs like penicillins, however, it has not been entirely clear which drugs are most commonly implicated in association with anaphylaxis, and most drugs do not have validated testing strategies.

In this original research article by Yu et. al, featured in The Journal of Allergy and Clinical Immunology: In Practice, the authors sought to examine the top drugs reported to the FDA’s Adverse Event Reporting System (FAERS) in association with anaphylaxis and anaphylaxis deaths, from 1999-2019. Because anaphylaxis to drugs is a rare event and individual cases are scattered throughout the population, the authors also sought to identify any emerging trends that might have previously gone unnoticed, in order to guide future research and clinical care.

From 1999-2019, there were 17,506,002 adverse drug events reported in FAERS, of which 47,496 (0.27%) were reported as anaphylaxis, confirming that it is a rare event when compared to other adverse events reported to the FDA. The median age of patients in reports of anaphylaxis was 52 years old, 62.71% were female, and 13,899 out of 34,381 (40.43%) reports were from the United States. There were 2,984/47,496 (6.28%) reports of anaphylaxis followed by death. The top drug classes associated with anaphylaxis in FAERS were antibiotics, monoclonal antibodies (mAbs), nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen. The top drug classes associated with anaphylaxis deaths were antibiotics, radiocontrast agents and intraoperative agents. The authors identified the top 50 drugs associated with anaphylaxis and the 56 drugs associated with more than 20 reports of anaphylaxis death, respectively, as reported to FAERS. Statistical analysis demonstrated that reports of anaphylaxis to mAbs increased at an average rate of 0.77 percent of total anaphylaxis reports per year (95% CI: 0.65, 0.88) from 2.00% in 1999 to 17.37% in 2019, faster than any other drug class. By comparison, anaphylaxis to antibiotics remained stable over time. This increase in anaphylaxis to monoclonal antibodies over time represents a new trend that has not been reported previously. The authors noted the limitations of self-reported FAERS data, and call on the field to pursue further research on anaphylaxis to drugs that may have gone unnoticed.  

The Journal of Allergy and Clinical Immunology: In Practice is an official journal of the AAAAI, focusing on practical information for the practicing clinician.

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