It’s not peanuts, bees, or latex that cause the majority of fatal allergic reactions in the United States. It’s medicine.

 

Authors of a new study in the Journal of Allergy and Clinical Immunology looked at data on deaths resulting from allergies and found that medicine was responsible for almost 60%. Examining mortality data from 1999-2010, the researchers also found that the annual number of allergy-related deaths has increased over time.

 

This increase is of particular concern because fatal anaphylaxis (allergy-related death) is on the rise around the world. Allergists have called it an epidemic. The United States has one of the highest rates of severe anaphylaxis in the developed world. Critics of the US healthcare system note that most of the study’s anaphylactic deaths took place in inpatient medical facilities, though this might simply be a result of where drugs like chemotherapeutics are usually administered.

 

Let’s focus on medicine-related fatalities. In almost 75% of cases examined by the study, the drug responsible for the anaphylaxis was not listed on the report submitted to the US National Mortality Database. This means that there’s no way to know whether specific drugs are likelier to cause reactions, as reactions aren’t being tracked by their causes. While at least nine European countries have partial or full national registries for tracking allergic fatalities, the United States does not. The study’s researchers closed their paper with a call for the establishment of a National Registry on Fatal Anaphylaxis.

 

This call echoes work done by the Berman Institute’s Ruth Faden, PhD, MPH, as co-chair of the Institutes of Medicine committee that published the 2012 report Ethical and Scientific Issues in Studying the Safety of Approved Drugs for the Food and Drug Administration (FDA). The committee was convened to examine how the FDA ought to follow and regulate drugs after they’ve been approved for sale. Ultimately, they recommended that

the FDA more fully embrace a life cycle approach to drug safety oversight. The life cycle approach places substantial emphasis on drug safety after the FDA approves a medicine for sale, and requires that the FDA anticipate and plan well in advance how it will monitor a drug’s safety over its market lifetime.

In the face of the rising number of anaphylaxis deaths, the need to closely track medicine safety appears particularly urgent.

 

 

 

For more information about the IOM report, click here.

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Theo Schall

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