Additional post-market surveillance is required to accurately determine potential risks of products containing caffeine
SafetyCall International today issued a statement in response to the Institute of Medicine’s (IOM) report released last week, “Examining Safety: Workshop Summary of Caffeine in Food and Dietary Supplements.” SafetyCall’s President of Regulatory and Scientific Affairs Dr. Richard Kingston, who participated in the workshop, stated that adverse event data presented during the meeting does not confirm that all products in question pose a public health issue. Kingston added that a more focused and targeted post-market surveillance effort will be required in order to accurately determine what, if any, risks are associated with specific products in the class.
Portions of the incident data analysis presented in the workshop by Dr. Steven Lipshultz, University of Miami, included poison control adverse event data that categorized 1,480 non-alcoholic energy drink exposures into outcomes by age group. Kingston stated the data summary excluded two of the most important outcome categories: 1) non-toxic, no follow-up, asymptomatic outcomes, and 2) minor effect, no follow-up outcomes. He said that if the excluded outcomes are included, children six years old or less had the lowest incidence of adverse effects, even though they had the highest exposure rate. And 85 percent of cases that involved children less than six years old were either non-toxic or resulted in minor adverse consequences. When six-to-12 year olds were included, incidents judged as non-toxic or without serious outcomes were still greater than 80 percent. Kingston explained that by not including those two outcome groups, the denominator is distorted, exaggerating the overall relative percentage of adverse effects for all populations. He said that a more meaningful statistic would be the average age of all symptomatic exposures, which would likely demonstrate that older teens and adults should be the target populations for examining potential risk mitigation opportunities. Based on the available data, it does not appear that children, especially those less than 13 years of age, are at any particular risk and potential risks for other populations have not been adequately defined.
Kingston went on to say that for all populations presented in the data, serious outcomes appeared to be uncommon. Even for the few cases that involved reports of more serious effects, virtually no incident details were available, such as what products may have been involved, formulation characteristics, caffeine doses and other factors. Manufacturers of these products are in the best position to collect product specific adverse event data that can both identify safety signals and further confirm the safety profile for any given product in the category.
Kingston concluded by stating an important take away from Lipschultz’s presentation: Before we can answer the question of whether or not one or more of these products pose a public health issue, more focused and targeted post-market surveillance is needed. Information collected will help us determine what products and formulations might give rise to adverse effects, especially in populations routinely consuming the products. With that information, injury prevention efforts can be directed at appropriate populations.
Soon the FDA will be digesting the findings and reporting back to Congress on next steps. “I suspect the FDA will review the IOM report and conclude that companies need to step up their efforts by collecting their own data to convince the Agency that their individual products are being used safely,” said Kingston. “Even though currently available incident data has not demonstrated that products in the category represent a major public health risk, it also does not confirm safety for every product out there.”
About Dr. Richard Kingston
Dr. Kingston is President, Regulatory and Scientific Affairs and co-founder of SafetyCall International. He has 30 years professional experience in the areas of clinical toxicology and pharmacology, poison control, product post-market surveillance, and drug and dietary supplement safety. Previously, Dr. Kingston co-founded and served as Director of the Minnesota Regional Poison Center and Hazard Information Services. He holds a joint academic appointment with the University of Minnesota at the rank of clinical professor within the College of Pharmacy. Dr. Kingston completed his Bachelor of Science in Pharmacy at the University of New Mexico, his Doctorate in Clinical Pharmacy at the University of Minnesota, and a Post-Doctoral Fellowship in Clinical Toxicology and Pharmacokinetics at St. Paul-Ramsey Medical Center and the University of Minnesota. In his academic capacity, he serves in multiple areas related to his practice focus of clinical toxicology and product safety.
About SafetyCall International
SafetyCall International is a multidisciplinary health care practice that provides manufacturers with adverse event management, regulatory reporting, post-market surveillance, and consulting services. It operates the world’s largest 24/7 human and animal adverse event call center, providing clients and their customers with immediate, around-the-clock access to trusted health, safety and medical information. As nationally-recognized experts in the collection and interpretation of spontaneously reported incident data, the professional staff has managed more than 2 million product incident cases in the past 30 years, significantly impacting product safety worldwide. SafetyCall® also operates Pet Poison Helpline, a 24/7 animal poison control service for pet owners and veterinary professionals. For more information, visit http://safetycall.com.