Lightly regulated dietary supplements send an estimated 23,005 Americans to the emergency department each year, according to a study published in the October 15 issue of the New England Journal of Medicine. Younger patients were more likely to suffer heart-related adverse effects from supplements promising weight loss or an energy boost; older patients were more likely to experience problems swallowing after taking a vitamin or mineral pill.
"On the basis of reports from a nationally representative sample of emergency departments from 2004 through 2013, we estimated that dietary supplements were implicated in an average of 23,000 emergency department visits and 2000 hospitalizations annually," write Andrew I. Geller, MD, from the Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia, and coauthors. "Although the numbers of emergency department visits and hospitalizations were less than 5% of the numbers that have been reported for pharmaceutical products previously, dietary supplements are regulated and marketed under the presumption of safety."
After a change in federal law that took effect October 1994, dietary supplements no longer need approval from the US Food and Drug Administration (FDA) before they are marketed. Now manufacturers, not the FDA, are responsible for ensuring that supplements are safe before being sold. According to the authors, the number of supplements sold in the United States rose from 4000 in 1994 to more than 55,000 in 2012. About half of adult Americans take at least one dietary supplement per month, spending $14.8 billion on herbal or complementary products in 2007 alone. If the FDA can demonstrate the supplement is unsafe, it can restrict its use: More than 200 dietary supplements were recalled from 2004 through 2012.
FDA warnings are not always sufficient, however. For example, the agency warned consumers and clinicians in 2013 about Reload, a supplement sold for sexual enhancement, because it contained sildenafil (Viagra, Pfizer). Yet just this week former NBA player Lamar Odom was found unresponsive in a Nevada brothel after reportedly taking multiple doses of the supplement.
In the current study, the researchers examined 10 years of surveillance data from 63 hospitals, identifying 3667 emergency department visits attributed to the use of herbal or complementary nutritional products, such as botanicals and microbial additives, and micronutrients, such as vitamins and minerals. (The authors excluded energy drinks and herbal teas from their analysis.)
On the basis of those visits, the researchers estimate that an average of 23,005 Americans made emergency visits each year as a result of supplement use, and 2154 were hospitalized annually.
Some 25.5% of emergency visits by adults came after use of a weight-loss product, whereas energy products were implicated in 10.0% of adults' visits. Patients most commonly reported feeling palpitations, chest pain, or tachycardia (42.9% of patients taking weight loss supplements and 46.0% of patients taking energy products).
"Although the incidence of emergency department visits for adverse drug events is reported to be low among young adults, more than one quarter (28%) of emergency department visits for supplement-related adverse events in our study involved young adults between the ages of 20 and 34 years," Dr Geller and colleagues write. "Unlike over-the-counter or prescription medications, there are no requirements to identify adverse effects on dietary-supplement packaging. Clinicians could be encouraged to educate patients about potential cardiac effects from these products."
Children's unsupervised use of supplements led to 21% of emergency department visits, with child-resistant packaging doing little to thwart children from ingesting iron supplements. Although almost 40% of emergency department visits for older patients involved problems swallowing, the authors note that FDA recommendations about the maximum size of pills do not apply to supplements.
"A limited regulatory framework makes it challenging to accurately monitor the safety of supplements," Dr Geller and coauthors conclude. "[Emergency department] visits commonly involved cardiovascular adverse effects from weight-loss or energy herbal products among young adults, unsupervised ingestion of micronutrients by children, and swallowing problems associated with micronutrients among older adults. These findings can help target interventions to reduce the risk of adverse events associated with the use of dietary supplements."
Financial support for the study was provided by the US Department of Health and Human Services. The authors report having no disclosures.
N Engl J Med. 2015;373:1531-1540. Abstract
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Cite this: Supplements Tied to 23K Emergency Department Visits Annually - Medscape - Oct 15, 2015.
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