Video Transcript: Researcher Steven Lipshultz, M.D., discusses Abstract 14841. He is the study’s senior author and professor and chair of pediatrics at Wayne State University and pediatrician-in-chief at Children’s Hospital of Michigan in Detroit, Michigan. “In the United States there's a poison control network, where families, patients, healthcare providers can call in concerns about potential toxicities associated with different products that are consumed. From 2010 to 2013, over 3 full years, the National Poison Database, comprised of all poison centers that participate in the United States, had a category for energy drinks. Our study looked at all of those recorded cases in the National Poison Database to see what sort of concerns regarding the health of children, teenagers, and adults were present. What we found was that, of all the cases recorded over 3 years that run the full spectrum of ages, that we would have expected that teenagers and young adults, being some of the largest consumers, would perhaps have the largest number of reported cases. We were surprised to find that more than 50% of all the recorded cases were in children less than 6 years old, and these were felt to be unintentional. By that the poison control system means that they did not go to the store and intentionally purchase these, but rather these were consumed ... Perhaps they were in the household refrigerator or elsewhere that were purchased by others. So, our concern was that we saw an unexpectedly high percentage of all the recorded cases over the 3-year period in children less than 6. Now your question was the type of problems. What we found was that, overall, there were the 3 highest categories of type of problems that were reported were neurologic problems, where somebody might feel jittery, somebody might feel anxious, somebody may even have a seizure. We then found the second most common was gastrointestinal. Somebody might feel nauseous, they might have an upset stomach, they might vomit, and others. The third most common class of symptoms that were recorded in the cases in the National Poison Data System were cardiovascular. People reported having faster heartbeats, heart rates, than what they normally would have. We call it 'tachycardia.' People called with concerns that their blood pressure was higher than it normally is. Some cases reported arrhythmias, abnormal heart rhythms. Of those cases that were recorded by the National Poison Data System, the trained experts at the poison control centers try to determine the level of concern, the level of severity. Some they just give reassurance and say, "This is really a minor effect." It can go as high as a major effect, which they classify as 'life-threatening.' When we look at moderate and major effects ... Those are effects where poison control would recommend that the particular person be seen in a health care facility ... one of the things that we found, especially of those that had major effects, potentially life-threatening, the majority, more than 50%, were cardiovascular problems. Again, that's part of why we're presenting this at the American Heart Association meeting. Our feeling was that, in the absence of any therapeutic benefit by consuming energy drinks, this supports what major organizations of physicians, including the American Academy of Pediatrics that deals with child and adolescent health providers, have said, that these should not be consumed by children and teenagers because of health concerns. The only acceptable toxicity would be zero in the absence of a therapeutic benefit. Here there were thousands of reported cases over the 3 years, and there was a disproportionally higher number of cases for young children, again giving objective evidence that what the American Academy of Pediatrics put in writing in 2011, saying that this should not be the type of beverages that children and teenagers consume ... This put some additional support based on real-world data around the United States. One of the things that we looked at in this 3-year study of all the cases reported to the National Poison Data System was, are these caffeinated energy drinks, sold to humans throughout the United States, are they similar or dissimilar from caffeine that is sold in other products? What we did, and we'll be presenting as we compare it, whether it's a [Starbuck 00:07:01] coffee, or it's a soda, to if it is in the setting of an energy drink. The suggestion from this data, reporting from the same time period at the same centers with the same criteria for severity, suggest that there's an increased frequency and increased severity of symptoms, and, in particular, an increase in cardiovascular complications for the cases recorded when it is a caffeinated energy drink compared to caffeine outside of an energy drink that has been consumed. That's part of what we will present. Why is that? Energy drinks have in it more than just caffeine. One cannot easily separate, is it this ingredient? Or that amount? Is it this ingredient? Or that amount? Is it another ingredient? The combination of ingredients in energy drinks that are sold to consumers have had little to no testing prior to their sale for safety in humans. Whether it is an additive effect or more than an additive effective in terms of health consequences is unknown. Poison control data is less than perfect, but it is about the only way we can ascertain, is there a safety signal? In this particular case it suggests that the combination of ingredients in energy drinks that are sold throughout the United States has more health consequences that are of concern than if one just has caffeine in a coffee or a soda. Then, for certain specific populations ... I'm a pediatric cardiologist. I take care of children who have cardiomyopathies, who have heart failure, who may be at greater risk than the normal population for having a dangerous or potentially life-threatening heart arrhythmia. Knowing that in this data set that there are arrhythmia that are appearing, it would tell me that, for other health providers, this is a stimulant that in a particularly susceptible patient, whether it be a child or an adult, they may want to avoid, because they may be a higher risk group. That's also important for families if they have a child with an underlying heart condition at increased risk for an arrhythmia that they discuss it at the dinner table so that everybody is a little bit more informed. We think that it's not only just in those situations. When we look at children across the United States that have hypertension, high blood pressure, and they're on medication to lower that blood pressure, we are seeing a high number of the cases reported to the National Poison Data System showing hypertension, high blood pressure. If it was one of my patients that is on prescription medication to lower blood pressure, my advice to that family would be, "In the absence of any therapeutic benefit by taking this, this has the possibility of increasing that blood pressure and making control by medication less effective." Similarly, we have seen seizures reported in the National Poison Data System. Those have also been reported in other poison data systems around the world, associated with consuming caffeinated energy drinks. If I was managing a child that had an underlying seizure disorder and was on anti-convulsant therapy, that might be another family that I would speak to about having them understand that this may lower the threshold for having a seizure. We also find in the United States 10% of all the children are reported to be diagnosed with ADHD, Attention Deficit Hyperactivity Disorder. Seventy percent of those children are treated with prescription medication to improve their concentration. The most common class of medication are stimulants. Having prescription stimulants and additional stimulants doesn't necessarily mean that those children and teenagers will have enhanced or improved concentration. The point is is this may be a class of food products that are safe for many people; but, for certain sub-populations, they may be at higher risk, and we really do not know who all of those people are. So, again, that's where this is suggesting that there really are safety and health concerns, at least for some people in the United States. In addition to the messages that I think are the implications of this study for healthcare providers and for families to be more aware of these, to enhance conversations between healthcare providers, families, patients, whether they be children, young adults, older, in terms of potential education and prevention, this raises several other areas for discussion. One, in the United States we do have restrictions on certain products where they're found to have potential dangerous health effects to children and teenagers. Alcohol is restricted below a certain age. Cigarette purchases are restricted. Driving is restricted. In this case, even in schools, these are sold in many locations. There's no restriction on purchase. The point is is that, even if you look at the recommendations that were made by the American Medical Association after a vote by their membership in 2013, saying these should not be marketed to anybody less than 18, not only are they appealing in terms of the marketing to people in that age range, but, if you look at the labels on these products, the people who consume these products do not normally read the medical literature. If you look at a cigarette package, it says "The Surgeon General says, 'This may cause cancer or other.'" Here responsible labeling should say that the largest organization of child health providers does not feel that this should be consumed by children and teenagers and that there are health adverse effects that have been shown and this may put you in danger. That type of responsible labeling becomes important. Similarly, even the type of packaging of the products. It's not that these are bottles that you can unscrew, by and large, and then put away. Many of these are intended for one-time consumption, making it easier for young children to sample or have access to these. So, labeling, packaging, restrictions, and, as I mentioned before, having families that have children, teenagers, young adults with certain health conditions understand that so that they can counsel and be counseled by their health providers may ultimately prevent and reduce unnecessary adverse health consequences.” copyright American Heart Association