The Natural Products Association (NPA) has challenged the methodology and findings of a study published in the New England Journal of Medicine that claimed dietary supplements are responsible for approximately 23,000 hospital visits each year. The Study, “Emergency Department Visits for Adverse Events Related to Dietary Supplements” based its findings on data from 63 emergency departments from 2004 through 2013 instead of relying on the official U.S. Food and Drug Administration’s (FDA) Serious Adverse Event Reporting database for dietary supplements.
“The laws that regulate supplements require official reporting of adverse events so that the regulators, the health care community and others can review the data and make informed public policy decisions. This so-called study excludes that very data, which is more than puzzling because it was written in part by FDA officials who know this,” said Dan Fabricant, PhD, NPA executive director and CEO.
“The facts are that adverse events from supplements are extremely low given their widespread usage, and most of these are the result of three factors: accidents, people not consulting with their doctor, or misuse of a product combined with other health factors,” Dr. Fabricant continued, “Supplements are safe, which is why millions of Americans use them every day.”
According to the United States Food and Drug Administration’s (FDA) website (www.fda.gov/Food/DietarySupplements/ReportAdverseEvent/) the Safety and Reporting Portal is a “convenient secure, and efficient method for letting FDA know when industry or consumers finds a problem with a dietary supplement.” Further, government data reported that there were 3,249 Adverse Event Reports for 2012, a far smaller number than the 23,000 annual average cited in the author’s report.
Even if the study estimates are accurate, the number of hospital visits suggested to relate to dietary supplements would represent 0.0001687 percent of the 136.3 million hospital visits each year, according to data from the Centers for Disease Control (CDC).
The study authors concede that their figures could be an over or under-representation, and that more than 90 percent of the patients who went to an emergency room were discharged.
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