Dr Hector MD, co-founder of the company Supplement Safety Solutions, which features an adverse events reporting program called Nutravigilance. Dr. Lopez spoke with NutraIngredients-USA about the program and what it can do for dietary supplement companies at the recent meeting of the International Society of Sports Nutrition meeting in Phoenix, AZ.
In a recent study, Lopez said he and his team selected the data collected on several clients to determine what wider trends could be observed. The data supports the dietary supplement industry’s general consensus that the products are safe. In addition, and perhaps surprisingly considering the consumer base and conditions of use, the data suggested that sports nutrition products were safest of all.
Sports nutrition brands have low SAE rate
“From our own database we selected two large sports nutrition brands and three general health and wellness brands. We looked at events from a 2 1/2 year period from March 2014 through Oct. 2016. During that time we assessed 41,885 unique adverse events (SAEs). Of all of these, only 0.49% met the criteria of a serious adverse event,” Lopez said.
“We also classified these by adverse event report type, using standard MedDRA coding,” Dr. Lopez said. “We grouped them by type and organ system classification. What the data suggest is that the rate of SAEs is lowest in the sports nutrition category.”
Dr. Lopez used the cautionary verb ‘to suggest’ in light of the relatively small sample. Even though there is a mountain of data, it pertains to only a few companies. Are sports nutrition consumers, perhaps gym rats already inured to discomfort as part of their training regimens, less likely to report a SAE than Joe Consumer? Would they tend to look on a debilitating bout of nausea or a severe headache as just part of the price of admission? Dr. Lopez said that could very well be the case.
“In terms of actual reported events the general health and wellness brands tend to have a higher overall report rate. Our hypothesis is that the sports nutrition consumer has a different expectation about the products. If they took a pre-workout product and felt jittery, they might not report that event. The general health and wellness consumer tends to be an older demographic and is more likely to be polypharmacy (i.e., consuming a variety of products),” Dr. Lopez said.
Data hold hidden value
Even with these caveats, Dr. Lopez said mining adverse events data can be a gold mine for dietary supplement companies. And he said his company’s system, which seeks to bolster in-house capabilities, offers a valuable alternative to other adverse events consulting services, which offer turnkey call center models in which the call receipts and data collection is handled by a third party and the results are reported back to the brand holder.
“Finding signals that can enhance product development in the future is part of the deliverables,” Dr. Lopez said. “We integrate adverse event reports back into a company’s GMPs and can identify root causes. Fro example, we can trace an event back to a mistake made by a contract manufacturer with one ingredient in one lot.”
According to the company the Nutravigilance program can help companies verify that they:
- Train their employees to recognize adverse events.
- Have detailed standard operating procedures for processing and reporting adverse events
- Have an appropriately trained “Responsible Person” identified to interface with regulatory agencies
- Regularly perform signal detection activities to assess ongoing product safety
- Assess relevant scientific and medical literature for safety-related reports.