By Ellen Feldman, MD
Altru Health System, Grand Forks, ND
Dr. Feldman reports no financial relationships relevant to this field of study.
SYNOPSIS: A 10-year chart review of 63 nationally representative emergency departments reveals 3667 cases of adverse events related to dietary supplement use; these are estimated to represent 23,005 emergency department visits yearly. Characteristics of the visits are described and categorized.
SOURCE: Geller A, et al. Emergency department visits for adverse events related to dietary supplements. N Engl J Med 2015;373: 1531-1540.
SUMMARY POINTS
- A chart review from 2004-2013 of 63 nationally representative hospitals reveals 3667 cases of emergency department (ED) visits related to adverse effects of dietary supplements (as defined in the article.)
- Calculated estimates based on these representative numbers are 23,005 ED visits and 2154 hospitalizations per year across the United States.
- The authors found that one-fifth of the total visits involved unsupervised ingestion by children. Another one-fourth of the total visits involved young adults, and half of these visits were related to weight loss or energy products. Among older patients, more than one-third of the visits involved choking.
“Be the kind of person who takes supplements — then skip the supplements.”
— Michael Pollan, Food Rules: An Eater’s Manual
More than 20% of Americans report the use of dietary supplements on a daily basis.1,2 Yet, there have been few studies looking at presentations of adverse events related to supplement use. In an effort to address this gap and begin to collect and analyze meaningful data, Geller et al reviewed 10 years of data (Jan. 1, 2004 to Dec. 31, 2013) collected from 63 hospitals enrolled in a study jointly coordinated by Centers for Disease Control and Prevention (CDC), the FDA, and the Consumer Product Safety Commission.
This ongoing study, known as The National Electronic Injury Surveillance System — Cooperative Adverse Drug Event Surveillance (NEISS-CADES) was developed to collect and track specific details of adverse drug events (ADE).3 The hospitals participating in the study were selected as a stratified probability sample of all U.S. hospitals with specified characteristics. Trained coders were present at each site to abstract relevant data, which was weighted to calculate national averages.
In this investigation of adverse events related specifically to dietary supplements, cases were selected based on the emergency department (ED) clinicians’ opinion that the presenting problem was related to use of dietary supplements. For purposes of the study, dietary supplements include herbal products in oral and topical form (botanicals); complementary nutritional products (amino acids supplements, some laxatives, probiotics); and micronutrients (orally ingested vitamin or mineral supplements). The study excluded food or drink products such as herbal teas and energy drinks. The study also excluded cases of intentional overdoses, abuse, withdrawal symptoms, therapeutic failures, and death as adverse events.
The authors identified 3667 cases from 2004 to 2013; 400 of these resulted in hospitalization. National estimates were derived from these numbers using statistical software and accounting for changes in population. These calculations led to the following estimates of annual nationally occurring events:
- 23,005 ED visits (95% confidence interval [CI], 18,611-27,398);
- 2154 hospitalizations (95% CI, 1342-2967);
- 87% of the visits involved a single agent.
Special Cases
Children: Unsupervised ingestion by children ≤ 10 years of age accounted for 946 visits (estimated 4871 visits annually) or just over one-fifth of the total cases; almost two-thirds of these cases involved ingestion of micronutrients such as multivitamins or iron. Supplements for sleep, weight loss, and relief of anxiety were implicated in most of the remaining cases.
Older Adults: An estimated 37.6% of the visits in this age group involved swallowing problems or airway obstruction. The bulk of the swallowing problems were related to micronutrients (83.1% estimated). In younger patients, swallowing problems were significantly less common (9.4%). (See Figure 1.)
Figure 1: Age of Patients (Total 3667) |
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(Note: Unsupervised ingestion by children accounts for 946 cases.) Data prior to national estimates. |
Weight Loss and Energy Products: After excluding cases of unsupervised ingestion by children, these products were implicated as causative agents in more than one-third of the visits. Weight loss products were related to 25.5% of these visits and energy products were involved in 10.0% of these visits.
Single Supplement Cases (after exclusion of unsupervised ingestion by children): Extrapolated data reveals that almost 66% of these cases involved herbal or non-herbal non-nutritional products as delineated above. (See Figure 2.) Micronutrients such as vitamins or minerals are implicated in the remaining 33% of the cases. In this category, multivitamins are involved in about 16% of identified cases, while calcium, iron, and potassium each are involved at an occurrence rate of < 5%.
Figure 2: Conditions for Which Dietary Supplements Were Used and Implicated in a Possible Adverse Effect |
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Patient Age and Product Type: Figure 3 shows the estimated annual ED visits (excluded are unsupervised ingestions by children ≤ 10 years old and cases with more than one supplement.)
Weight Loss Products and Age: Estimated number of ADE cases according to age of patient. National estimate of events associated with weight-loss products in those > 65 years of age may be unreliable due to the small numbers involved. (See Figure 3.)
Figure 3: Annual Emergency Department Visits by Age and Product Type |
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COMMENTARY
The popular press wasted no time alerting the general public to the findings of this study.3 Reactions varied among the publications and ranged from calling for more controls on “dangerous” dietary supplements to espousing the relative safety of these products compared to their prescription counterparts.4-6
True enough, a comparable study in 2006 reviewing adverse events related to conventional pharmaceutical products found a weighted annual estimate of just over 700,000 such events annually across the United States — a number about 30 times higher than the 23,000 yearly visits estimated in this study of adverse events related to nutritional supplements.7
Yet one can certainly argue that 23,000 annual ED visits related to any one category of product is unacceptable and that looking toward prevention is necessary. In this regard, two areas of potential harm-reduction emerge fairly readily.
The first involves the 946 cases of children presenting to EDs with unsupervised ingestion of a dietary supplement. Childproof lids currently are not required on dietary supplements unless the supplement contains > 250 mg of elemental iron.8 Legislation or voluntary action by product manufacturers would be ideal; however, while waiting for such action, primary care practitioners can play a major role by reminding caregivers of young children of the absence of such lids and the wisdom of keeping dietary supplements in secured areas, even if the supplement happens to have child-proof packaging.
The second area involves persons on the other end of the age spectrum. Almost 40% of ED visits for those > 65 years of age involved some form of swallowing dysfunction. Encouraging older adults to utilize the newer mini-multivitamins and to examine the sizes of supplements before purchasing may help reduce the number of visits among this population. Educating the elderly regarding this problem and teaching them about FDA recommendations for size of pharmaceutical tablets (22 mm) is another area of potential intervention.9
Another area in which primary care providers can play an important role is warning patients about the potential of weight loss and energy products to precipitate cardiac symptoms. Urging product manufactures to acknowledge the possibility of cardiac side effects on relevant product labels also can help patients develop a more nuanced understanding of the role of these products in overall health care.
The authors acknowledged several limitations in the study. There are relatively wide confidence intervals around the estimated national values due to inherent limitations of estimating based on small sample sizes. They acknowledged the numbers may over-represent or under-represent the actual number of cases.
Recall that the identification of cases for inclusion in this study rely primarily on an ED physician opinion. Errors here can result in a distortion in numbers of cases identified — over-identification if the symptoms are incorrectly attributed to a supplement or under-identification in cases where the ED physician is not aware a supplement is in use.
As awareness of potential adverse effects of supplements grows, it seems more likely that medical practitioners will begin to incorporate questions about patient use of supplements into a routine history. Asking such questions and addressing specific at-risk groups can help both clarify and potentially reduce the adverse events related to use of dietary supplements. Reporting suspected adverse reactions to manufactures and the FDA MedWatch program10 will assist in developing an accurate ongoing data bank.
The findings from this study can be understood as clear notice to medical providers regarding the importance of recognizing the critical impact of discussing dietary supplement use with patients, as well as a reminder to include the relatively small yet still significant chance for precipitation of an unexpected event. Preventive measures, such as reminding parents of young children to securely store supplements and warning older patients to assess size of products, seem to be easily implemented, cost-effective strategies with the potential to reduce harm in these groups.
REFERENCES
- Dickinson A, MacKay D. Health habits and other characteristics of dietary supplement users: A review. Nutr J 2014;13:14.
- Barnes PM, et al. Complementary and alternative medicine use among adults and children: United States, 2007. Natl Health Stat Report 2008;12:1-23.
- Jhung MA, et al. Evaluation and overview of the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance Project (NEISS-CADES). Med Care 2007;45(Suppl 2):S96-S102.
- O’Connor A. Dietary Supplements Lead to 20,000 ER Visits Yearly, Study Finds. The New York Times Oct. 14, 2015. Available at: http://well.blogs.nytimes.com/2015/10/14/dietary-supplements-lead-to-20000-e-r-visits-yearly-study-finds/?_r=0. Accessed Dec. 1, 2015.
- Fox M. Supplements Send Thousands of Americans to Emergency Room Every Year, Study Finds. NBC News. Oct .14, 2015. Available at: http://www.nbcnews.com/health/health-news/supplements-send-thousands-people-emergency-room-every-year-study-finds-n444681. Accessed Dec. 1, 2015.
- Cha AE. Dietary supplements send more than 23,000 people to the ER each year. The Washington Post Oct. 15, 2015. Available at: https://www.washingtonpost.com/news/to-your-health/wp/2015/10/14/more-than-23000-people-wind-up-in-the-er-each-year-due-to-dietary-supplements/. Accessed Dec. 1, 2015.
- Budnitz DS, et al. National surveillance of emergency department visits for outpatient adverse drug events. JAMA 2006;296:1858-1866.
- Subchapter E — Poison Prevention Packaging Act of 1970 Regulations, Part 1700 — Poison Prevention Packaging; 38 FR 21247, Aug. 7, 1973, as amended at 41 FR 22266, June 2, 1976; 48 FR 57480, Dec. 30, 1983.
- Center for Drug Evaluation and Research. Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules: Guidance for Industry. Silver Spring, MD; June 18, 2015.
- MedWatch Online Voluntary Reporting Form. Available at: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home. Accessed Dec. 1, 2015.
A 10-year chart review of 63 nationally representative emergency departments reveals 3667 cases of adverse events related to dietary supplement use; these are estimated to represent 23,005 emergency department visits yearly. Characteristics of the visits are described and categorized.
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