The media has once again failed to report the whole story or put things into the proper perspective when they reported on a study from the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). The headlines and superficial reports were completely blown out of proportion. Keep in mind that it is estimated that over-the-counter and prescription drugs are responsible for more than 4 million emergency room (ER) visits annually. In addition, adverse drug reactions are estimated to cause over 100,000 deaths each year. These numbers are sobering and reflect the real issue that the media should focus on. If anything, this new report shows how safe dietary supplements are.
The authors of the study clearly stated that the numbers of ER visits were less than 5% of the numbers that have been previously reported for pharmaceutical products and the severity of the adverse effects are considerably less for dietary supplements. But somehow, this important perspective was lost by the media.
One of the greatest myths the media loves to perpetuate is that the dietary supplement industry is not regulated. The truth is that all dietary supplements, including vitamins, minerals, herbs and specialty products must conform to federal regulations that control manufacturing, labeling and advertising practices. Specifically, the FDA has the power to:
- Refer for criminal action any company that sells a dietary supplement that is toxic or unsanitary.
- Seize dietary supplements that pose an “unreasonable or significant risk of illness or injury”.
- Stop a new dietary ingredient from being marketed if the FDA does not receive enough safety data in advance.
- Stop the sale of an entire class of dietary supplements if they pose an imminent public health hazard.
- Obtain an injunction against the sale of a dietary supplement that has false or unsubstantiated claims.
- Require dietary supplements to meet strict manufacturing guidelines, called Good Manufacturing Practices, including potency, cleanliness, and stability.
The safety of dietary supplements has been well established over the years. Issues such as the contaminated L-tryptophan in the 1980s due to a change in the manufacturing process by one manufacturer or the abuse of ephedrine as weight loss agent were unfortunate occurrences, but should not detract from the excellent safety profile of dietary supplements. After all, even more significant issues have occurred in the food supply, as well as with prescription and OTC drugs.
It is estimated for the past two decades that roughly 70 percent of Americans utilize dietary supplements. In 2010, over 60 billion doses of nutritional supplements were ingested. According to the annual report from the U.S. National Poison Data System, not a single death was caused by a vitamin or mineral supplement. Again, keep in mind that in that same year prescription and OTC drugs caused well over 4 million ER visits and over 125,000 deaths. So why the big concern with dietary supplements?
To evaluate the safety of dietary supplements, the CDC evaluated the adverse event reporting (AER) data from 63 emergency departments over a 10-year period (2004-2013). The researchers estimated that based upon the data, dietary supplements are responsible for approximately 23,000 ER visits and 2,000 hospitalizations annually. Weight loss and energy products were responsible for 72% of AERs while sexual enhancement and body building products accounted for 14%. So, these two categories together equal 86% of the reported AERs. Now, in these 86% of cases, 90% of the time, the presenting AERs were heart palpitations, chest pain, or increased heart rate related primarily to caffeine ingestion and these patients were subsequently discharged from the ER.
The two other primary causes for ER visits were swallowing problems and unsupervised ingestion by children. About 50% of the swallowing problems occurred in elderly subjects and involved calcium supplements. In over two thirds of children presenting to the ER due to a AER it was related to unsupervised ingestion of a multiple vitamin and mineral formula and these visits were mainly precautionary.
Putting these numbers into perspective it is first important that the study did not highlight any serious AERs or deaths due to dietary supplements. Second, the major issue appeared to be people reacting to the caffeine in energy, weight loss and body building products. One of the problems of the report is that it did not detail the simultaneous ingestion of other sources of caffeine by subjects, reporting only side effects due to dietary supplements.
One issue that the report touched on is that the dietary supplement industry still contains some unscrupulous companies that market adulterated products – sometimes laced with prescription drugs. These are the rare exception and not the norm. This issue simply is non-existent among well-respected brands that adhere to high quality good manufacturing practices (GMP). Buyer beware that a product being called “Herbal Viagra” being marketed by a company on the Internet with zero distribution in health food stores and no history may be one of the products that has been shown to be adulterated with actual Viagra. Again, a well respected established brand, is simply not going to do that. From 2004 through 2012 more than 200 products were recalled by the FDA as containing unapproved regulated substances (i.e., drugs) or impurities.
Here should be the take away from this report.
- Dietary supplements are remarkably safe given their widespread use and lack of ER visits.
- Don’t use dubious natural products, especially those being marketed with weight loss, body building or sexual enhancement claims.
- If you are going to use a product containing caffeine, do so wisely and do not exceed the recommended dosage levels on the label, and also take into consideration additional intake of caffeine or other stimulants you ingest.
- If you have difficulty swallowing large pills, choose smaller pills or other delivery methods. Soft gels are generally easier to swallow and most supplements are now available in powder or liquid form.
- If you have children, make sure that your supplements are out of their reach.
These simple precautions would likely dramatically reduce the relatively small number of people using supplements from ever having to visit an ER due to a possible side effect.
Geller AI, Shehab N, Weidle NJ, et al. Emergency Department Visits for Adverse Events Related to Dietary Supplements. N Engl J Med. 2015 Oct 15;373(16):1531-40.
Dr. Michael Murray