Common dietary supplements are responsible for tens or thousands of emergency room visits each year in the United States, according to new research that highlights why the products should be an area of major concern for health and safety for regulators.
Researchers from the U.S. Centers for Disease Control and Prevention found more than 23,000 emergency room visits related to dietary supplements occur every year, resulting in an average of 2,154 hospitalizations annually. The findings were published online October 15, in the New England Journal of Medicine.
The study focused on a total of 3,667 cases taken from surveillance data of 63 emergency room departments from 2004 to 2013.
Of the hospitalizations, 28% involved young adults between the ages of 20 to 34, and 21% involved unsupervised children. Researchers say this points to the need for better child proof packaging, since most of these visits concerned vitamins, iron, weight loss and sleep sedation products.
When researchers removed the data from unsupervised ingestions of supplements by children, a total of 66% of the emergency room (ER) visits were for a single supplement related event involving herbal or complementary medicine.
The majority of the time, the emergency events involved micronutrients, like vitamins and minerals, however 25% of the time it involved products used for weight loss and 10% of the time for products used to increase energy.
When weight loss or energy products were involved, 72% of those emergencies involved heart palpitations, chest pain and tachycardia. A total of 58% involved people between the ages of 20 and 34.
Among adults older than 65, choking, or swallowing issues caused 38% of those ER visits. Micronutrients, vitamins and minerals, were involved in 83% of these cases, revealing a potential need to limit the size and shape of the pills and tablets, researchers noted.
Little FDA Oversight
Critics often warn regulation of dietary supplements, such as vitamins, weight loss products, energy products, herbs and others, is far too lenient in the United States.
In 1994, the Dietary Supplement and Health Education Act (DSHEA) was introduced restricting supplements from being marketed as curing a disease, however the products do not need FDA approval to come to market. Since then, the number of supplements on the market rose from 4,000 to more than 55,000.
Unlike prescription drugs, dietary supplements are not required to have warnings about adverse effects. However, the total of emergency room visits each year for supplements is less than five percent of those attributed to pharmaceutical drugs.
While FDA approval is not needed to market a dietary supplement, the agency can step in if there is a problem, such as if they contain active, regulated drug ingredients not listed on the label. Unlabeled drug ingredients have resulted in about 200 drug recalls forced by the agency since 2004. However, there are other instances where adverse events and serious side effects lead the FDA to step in to regulate or recall a dietary supplement.
A Zicam recall was issued in 2009 after the FDA identified at least 120 adverse event reports involving loss of smell with Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Swabs Kids Size.
In the aftermath of the recall, FDA inspectors discovered 800 reports of Zicam problems that Matrixx Initiatives failed to forward to the agency, in violation of federal regulations.
In 2013, the FDA forced USPLabs to issue an OxyElite Pro recall after the muscle-building supplement was linked to a rash of liver damage claims.
After nearly 60 cases of OxyElite Pro liver damage were identified by state and federal agencies, the FDA forced USPLabs to remove the product from the market on November 10, 2013. A number of lawsuits followed.
The FDA and other health agencies determined that the weight supplement contained aegeline, an extract from the Bael tree, which is native to India and southeast Asia. The FDA ruled that the product was adulterated because aegeline is relatively untested and its side effects are unknown.
Researchers are calling for more specific interventions to reduce the risk of adverse effect by dietary supplements. They warn that the numbers used in this study are probably a low estimation because problems involving dietary supplements are often underreported. Likewise, many people are often unaware their symptoms may be related to dietary supplement side effects.