The study, titled Serious Adverse Events Reported with Dietary Supplement Use in the United States: A 2.5 Year Experience, used data from two manufacturers that are clients of Supplement Safety Solutions, a firm that helps manage and analyze adverse event reports for companies.
The paper was written by SSS personnel, as well as employees of the trade group Council for Responsible Nutrition, who included Duffy MacKay, ND, CRN’s senior vice president of regulatory and scientific affairs.
Approach borrowed from pharma realm
SSS uses an approach to adverse event reporting it calls nutravigilance, which it defines as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects related to the use of a food, dietary supplement, or medical food.”
“The approach utilizes some of the established and best practices of the pharmaceutical industry,” the authors wrote. It incorporates MedDRA (Medical Dictionary for Regulatory Activities) coding, which is a highly specific, standardized medical terminology.
Applying that terminology to the data set that SSS has built up with the two major customers, the authors said they could conduct an analysis that included dietary supplement type as well as how the events were related to what was called System Organ Class (SOC).
“We wanted to add data to the story so that you can better define and discuss the whole topic of dietary supplement safety,” MacKay told NutraIngredients-USA. “This is a good data set. I was participating because we here at CRN were encouraging them to look at their data to see what it says.”
The study took a look at more than 41,000 reports for the two manufactures. These were gathered over the period from March 1, 2014 to Aug. 31, 2016. The report found that overall, only a tiny fraction of all adverse events reports collected by the two manufacturers rose to the level of a serious adverse event.
All reports that were suspected to be an SAE were evaluated by an SSS-trained physician. At least two follow-up attempts via phone or email were made to speak with the person who reported the event. If no contact could be made, the physician made a clinical judgement about whether the event truly represented an SAE.
Only tiny fraction rose to SAE level
“Of the 41,121 AE cases reported, 203 (0.48%) were SAEs. SAEs tended to occur with products marketed for weight loss (69.0%) and glycemic control (19.2%). SAEs occurred most commonly in the cardiovascular, gastrointestinal, and nervous system disorder SOCs,” the authors wrote.
Of the 203 adverse events, 144 of them happened to women while 59 were reported by men. The median age of the female event reporters was 59, with a range of 15 to 87, and for the men the median age was almost 70, with a range of 21 to 104 years of age. Dizziness, nausea, vomiting, dehydration and headache were the most commonly reported symptoms.
MacKay cautioned against overemphasizing the import of the results. But he said the study is another bit of proof that dietary supplements overall are a safe category of products.
Data makes safety point
“This is one more data point. We often talk about data relating to the supplement industry that has no denominator. We have seen the misuse of data derived from things like emergency room visits,” MacKay said.
“That is not a clean data set. For example, a big reason that people go to the emergency room in regard to supplements is choking on capsules. And then you hear some people saying dietary supplements have been responsible for 23,000 emergency room visits. Poison control data is another not so fit for purpose data set when discussing dietary supplement data in a real world way,” he added.
“It’s our responsibility to counter that narrative with some real world data. I would encourage people not to over interpret these findings, but to begin to use them to define our industry with some real numbers,” MacKay said.
Source: Journal of Dietary Supplements
Serious Adverse Events Reported with Dietary Supplement Use in the United States: A 2.5 Experience
doi.org/10.1080/19390211.2018.1513109
Authors: Schmitz SM, Lopez HL, MacKay D, Nguyen H, Miller PE
