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Responses from supplement industry leaders aimed to put the findings in context.
Dietary supplements send 23,000 people to U.S. emergency rooms each year, alleges a recent analysis1 published in the New England Journal of Medicine. The analysis was funded in part by the U.S. Department of Health and Human Services. Responses from supplement industry leaders aimed to put the findings in context.
The authors pooled data from 63 hospital emergency departments in the United States in 2004–2013 and tallied patient visits related to dietary supplement usage. Overall, they evaluated 3667 cases and, based on that number, estimated that 23,005 visits per year are related to adverse events stemming from dietary supplement intake. According to the report, of those ER visits, 2154 escalated to hospitalization. The authors pointed out that visits frequently involved young adults or children whose supplement intake was unsupervised.
Excluding supplements taken by unsupervised children, 65.9% of emergency room visits were related to “herbal or complementary nutritional products;” 31.8% were related to micronutrients; and weight-loss or energy-boosting supplements caused 71.8% of adverse events related to palpitations and chest pain, with at least 65% of the sufferers young adults 20–34 years of age. Choking on supplements was linked to 37.6% of visits by senior adults aged 65 and older.
The authors concluded, “Such visits commonly involve cardiovascular manifestations from weight-loss or energy products among young adults and swallowing problems, often associated with micronutrients, among older adults.”
Consider the Context
Dietary supplement industry associations the Council for Responsible Nutrition (CRN; Washington, DC) and the Natural Products Association (NPA; Washington, DC) responded to the findings.
Duffy MacKay, ND, CRN’s senior vice president of scientific and regulatory affairs, encouraged the public to consider the 23,000 alleged ER visits within the far higher number of overall supplement users who used products without an adverse event.
“The results of this study reinforce that dietary supplements are safe products, particularly when put into context with the number of people-over 150 million Americans-who take dietary supplements every year. To put this projected number of 23,000 annual emergency room (ER) visits into context, we estimate that far less than one-tenth of one percent of dietary supplement users experience emergency room visits annually.” He also pointed out that some products were included in the study that might not be considered supplements, such as eyedrops, eardrops, and “other OTC and non-dietary supplement products inaccurately included by the researchers….”
NPA’s executive director and CEO, Dan Fabricant, PhD, contended that the incidence of adverse events related to supplements is actually far lower according to the FDA’s official Serious Adverse Event Reporting database, where supplement manufacturers are by law required to report adverse events and which Fabricant argued is a far better measure of adverse events.
“The laws that regulate supplements require official reporting of adverse events so that the regulators, the healthcare community, and others can review the data and make informed public policy decisions,” Fabricant said in a press release. “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.” By Fabricant’s estimates based on FDA’s database information for one year, 2012, there were far fewer adverse events that year than what the New England Journal of Medicine authors estimate happen annually. Government data showed that there were 3,249 adverse events reported for supplements, which is far lower than the 23,000 number of ER visits reported by the authors.
“Even if the study estimates are accurate, the number of hospital visits suggested to relate to dietary supplements would represent 0.0001687% of the 136.3 million hospital visits each year” related to all types of adverse events, not just those related to supplements, Fabricant pointed out, citing Centers for Disease Control data. “The study authors concede that their figures could be an over- or under-representation, and that over 90% of the patients who went to an emergency room were discharged," NPA said.
Speaking on behalf of the supplements industry, CRN’s MacKay said the industry still appreciates any “reasonable” takeaways the study offers. For instance, he said, it’s good for supplement makers to continue innovating dosage forms that make supplements easier to swallow, pointing to growing options such as liquids, gummies, melts, and effervescent powders.
“Consumer safety is a top priority for the dietary supplement industry,” MacKay said. “We recommend that supplement users store dietary supplement products in safe places, out of a child’s reach; discard supplements after the expiration date; and read and follow label instructions. In addition, we recommend consumers talk with their doctor or pediatrician about their family’s supplement use.”
Nutritional Outlook magazine
Geller A et al., “Emergency department visits for adverse events related to dietary supplements,” New England Journal of Medicine. Published online October 15, 2015.