An article published in last week's New England Journal of Medicine presents a review of emergency room (ER) visits to 63 hospitals between 2004 and 2013 reportedly associated with dietary supplements and other products such as over-the-counter drugs and skin creams (Geller AI et al., 2015). Extrapolating from this data, the authors estimate an average of 23,005 ER visits for adverse events associated with dietary supplements annually and calculate that about 9% of these would actually result in hospitalizations.
The authors of the dietary supplement study include four employees of the Center for Disease Control (CDC) and three employees of the Food and Drug Administration (FDA). Some of these same authors have conducted similar analyses on unsupervised pediatric medication exposures (estimating 54,000-76,000 ER visits annually between 2004 and 2013) (Lovegrove MC et al., 2015) and on insulin-related hypoglycemia and errors (estimating 98,000 ER visits each year, primarily in elderly persons (80 years or older), with over one-third resulting in hospitalization) (Geller AI et al., 2014).
Article includes drugs, cosmetics and other non-supplement products
In last week's NEJM article, Geller et al. incorporate several products that do not meet the federal definition of dietary supplements. These include products that are regulated and lawfully marketed as drugs, including eye drops, ear drops, and homeopathic products; topical treatments like skin cream; and at least two misbranded drugs found by FDA to contain undeclared active pharmaceutical ingredients. The authors confirm that these are "also included in the analysis" in spite of the implication of the article's title (and the resulting media emphasis) as relevant only to dietary supplements. Because no per-product information is provided on the number of reported hospital visits there is no way to know what portion of these visits were associated with products that are not dietary supplements.
A fraction of ER visits are associated with supplements
Every year, roughly 136 million people visit the ER in the U.S. The just over 23,000 visits estimated by Geller et al. as associated with supplements (and some non-supplement products) represents about 0.017% of these ER visits.
Health agencies such as the CDC and National Institutes of Health have for many years compiled information on the numbers and causes of emergency department visits and hospitalizations in the U.S. A sampling of some of this data is provided below to provide some perspective on the supplement numbers in this article:
• 731,000 hospital ER visits every year are associated with prescription drugs (taken as a doctor prescribed) (CDC, 2015)
• 775,000 of the 30 million children participating in organized sports visit an ER annually (Johns Hopkins Medicine, 2015)
• Over 1.2 million ER visits every year for first-listed alcohol-related diagnoses for persons ages 12 years and older (National Institutes of Health, 2013)
• Roughly 2.3 million people visit an ER each year in association with a headache (CDC, 2015)
• Approximately 136 million total ER visits took place in 2011 (CDC, 2015)
A fraction of supplement users visit the ER due to supplement use
Roughly 166 million Americans use supplements each year (CDC, 2011). According to Geller et al., about 23,000 would be expected to have an ER visit associated with their consumption, representing less than 0.014% of all supplement users. As already noted, many of the products included in the article's numbers are actually drugs (lawful or otherwise) or topical products, rather than supplements, so the number estimated for supplement-associated ER visits would be lower if these products were excluded from the data. The authors also identify several possible limitations of their analysis, noting that the number of estimated ER visits "is probably an underestimation," but also acknowledging their data gathering methods "could lead to overestimation."
Unsupervised ingestion by small children
More than 20% of the ER visits in the Geller report were attributed to unsupervised ingestion by children under the age of four, representing about 4,900 expected ER visits annually. While this is a serious matter, it does not indicate concern over the safety of dietary supplement use, but instead suggests a need to ensure that adults supervise children's access to supplements. This same parental responsibility is also relevant to the 54,000 to 76,000 estimated annual ER visits over the last decade associated with all unsupervised pediatric medical exposures, as reported in the current issue of the journal Pediatrics by some of the same authors of the article on supplement-associated ER visits (Lovegrove MC, 2015), though without the same media fanfare.
“Marketers of dietary supplements are committed to providing safe products for our millions of consumers, as is required under federal law,” said Michael McGuffin, president of AHPA.
“This study, when placed into the context of the U.S. population of supplement users and compared to other product categories, demonstrates the relative safety of this product class.”
Supplement marketers must inform FDA of serious adverse event reports; AHPA recommends informing physicians of supplement use
Reflecting its uncompromising commitment to ensuring supplement products are safe, AHPA petitioned FDA in 2003 to require dietary supplement marketers to submit all serious adverse event reports received from their customers to the agency. When FDA responded that it did not have the authority to establish this responsible requirement, the supplement industry worked cooperatively to get a law passed in 2006 to grant this new power to FDA.
In addition, AHPA adopted a recommendation in 2001 that consumers of herbal supplements inform their healthcare providers of such use. In the interest of seeing this recommendation broadly accepted by consumers, AHPA also encourages healthcare providers to receive such communication with respect for the consumers' healthcare choices and to seek out accurate and truthful information about herbs.
CDC. (2011, April). NCHS Data Brief, Dietary Supplement Use Among U.S. Adults Has Increased Since NHANES III (1988-1994).
CDC. (2015, April 29). National Hospital Ambulatory Medical Care Survey: 2011 Emergency Department Summary Tables.
Geller AI et al. (2015). Emergency Department Visits for Adverse Events Related to Dietary Supplements. New England Journal of Medicine, 373(16):1531-1540.
Geller AI, et al. (2014). National estimates of insulin-related hypoglycemia and errors leading to emergency department visits and hospitalizations. JAMA Internal Medicine, 174(5):678-686.
Johns Hopkins Medicine. (2015, Oct. 16). Sports Injury Statistics. Retrieved from Johns Hopkins Medicine web site: http://www.hopkinsmedicine.org/healthlibrary/conditions/pediatrics/sports_injury_statistics_90,p02787
Lovegrove MC, Weidle NJ, Budnitz DS (2015). Trends in Emergency Department Visits for Unsupervised Pediatric Medication Exposures, 2004-2013. Pediatrics, 136(4):821-829.
National Institutes of Health. (2013, September). Alcohol-related emergency department visits and hospitalizations and their co-occurring drug-related, mental health, and injury conditions in the United States: Findings from the 2006-2010 Nationwide emergency department sample (NEDS) etc.