Allergic Reactions From Drug-Eluting Stents

Drug-eluting stents, which can greatly reduce the risk of restenosis, can cause allergic reactions with serious consequences, including death, according to new findings.

Researchers from Northwestern Memorial Hospital (Chicago, IL, USA) reviewed 5,783 reports from 10 centers nationwide and identified 17 cases of hypersensitivity reactions that were classified as probably or certainly caused by drug-eluting stents, four of which resulted in death. Symptoms included rash, difficulty breathing, hives, itching, and fevers. The researchers concluded that the polymer coating on the stent is the most probable cause of hypersensitivity in the majority of cases rather than the medications coating the stent.

The findings were published in the January 3, 2006, issue of the Journal of the American College of Cardiology. The researchers also concluded that further research is warranted to better understand this risk and to develop a skin test to identify people who might be at high risk for hypersensitivity to drug-eluting stents.

"It is important to keep the findings in perspective,” said Dr. Charles J. Davidson, an author on the paper and professor of medicine at Northwestern University's Feinberg School of Medicine. "Drug-eluting stents are a life-saving advance used by hundreds of thousands of people that have greatly reduced the risk of restenosis. We are in no way recommending they be used less, but we do think that health professionals should be vigilant in watching for this problem.”

The study was based on reports from the Research Adverse Drug/Device Events and Reports (RADAR) Project, which compiles information from reports submitted to the database of the U.S. Food and Drug Administration's (FDA) as well as reports by drug companies and independent researchers throughout the world.




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