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Fatal Caffeine Overdose and Other Risks from Dietary Supplements

2014; Lippincott Williams & Wilkins; Volume: 13; Issue: 6 Linguagem: Inglês

10.1249/jsr.0000000000000094

1537-8918

E. Randy Eichner,

Tea Polyphenols and Effects

Introduction Dietary supplements are riding high, fast, and loose. Americans spend more than $32 billion a year on some 85,000 supplements, assuming them to be safe and effective. This is a dangerous illusion because the 1994 Dietary Supplement Health and Education Act opened the door to selling supplements without premarketing approval or safety testing. Dietary supplements are deemed safe until people get sick or die from them. Then, in the wake of the harm, the U.S. Food and Drug Administration (FDA) has to prove that the supplement is unsafe to get it off the market. Until every ingredient undergoes strict safety testing before marketing, the dietary supplement industry will remain a shadowy and hazardous land of caveat emptor. Let me elaborate with recent troubling examples. Fatal Caffeine Overdose In May 2014, Logan Stiner, 18 years old, a star wrestler, a top student, and senior prom king at a high school in Ohio, left school early for lunch at home. At 11 a.m., his brother found him on the floor. Emergency personnel pronounced Stiner dead. At autopsy, his blood caffeine level was >70 mg·L−1. His death was attributed to a cardiac arrhythmia and a seizure from caffeine overdose. His mother found in the home one bag of caffeine powder, which Stiner may have used as a preworkout supplement. A similar caffeine overdose death occurred recently in Georgia. A 39-year-old physical fitness buff was fired from his job because of aggression. Two hours later, he was found dead at his front door. Dried white fluid was sprayed in the cab of his truck and on the front of his shirt. A newly opened bag of caffeine powder was in the cab, along with a cup with traces of it. At autopsy, his blood caffeine level was 350 mg·L−1 (9). Caffeine deaths have been rare but are on the rise (2,6,8,10). When I wrote about caffeine in 2011, I covered three caffeine deaths, including a 23-year-old man who took two spoonfuls of caffeine powder at a party (6). A review cites 45 caffeine deaths in the medical literature up to 2010 (9), and more have occurred since then. Nonfatal ventricular fibrillation from high caffeine intake also has been reported recently (3). Last year, the FDA began investigating reports of adverse events and deaths associated with caffeine-based energy drinks. In July 2014, the FDA also warned about caffeine powder, which, as a "dietary supplement," is sold in bulk over the Internet (7). This is pure caffeine, and 1 tsp of powder may equal 25 cups of coffee. Some packaging labels fail to warn of the narrow margin of safety or the risk of death from overdose. Labels recommend 1/16th (apparently about 200 mg of caffeine) or 1/32nd tsp, but to measure precisely, you need a digital milligram scale. Anyone who digs into a bag of caffeine powder with a kitchen spoon to estimate dose may end up dead. The pearl: "The poison is in the dose." Restricting sales of over-the-counter caffeine tablets in Sweden likely reduced fatalities, especially suicides (15). At least caffeine tablets are labeled as to dose. In contrast, the chancy dosing of caffeine powder sets the stage for accidental and fatal overdose. Caffeine powder seems mainly a public health menace. Liver Failure from OxyELITE Pro Credit Linda Wong, MD, in Honolulu for spotting a dangerous common-source outbreak of toxic hepatitis. Wong did the first liver transplant in Hawaii in 1993. Beginning in May 2013, she saw four cases of acute liver failure in 4 months—more such cases than Professor Wong, the head of Hawaii's only liver transplant program, would typically expect in a year. These cases were not typical. None had any of the usual causes of grave liver failure. Most were young or middle-aged bodybuilders or dieters. Wong found they all used a dietary supplement touted as a muscle builder and a fat burner: OxyELITE Pro (OEP). By September 2013, Wong and colleagues had seen 8 victims of OEP in 5 months (14). Two got liver transplants, one (too sick to transplant) died, and one was inadvertently rechallenged and again got hepatitis. In September, Wong notified the Hawaii Department of Health (HDOH). Their epidemiologists worked with the FDA and the U.S. Centers for Disease Control and Prevention. By October, having tied 29 cases of toxic hepatitis to OEP, the HDOH removed it from stores. By November, under legal threat by the FDA, the Texas firm that makes OEP, USPlabs, issued a recall and destroyed stockpiles (11,12,16). The final count is unclear; new OEP cases were seen in Hawaii in early 2014, and one report claims nearly 100 cases in 16 states (13). Also unclear is what ingredient of OEP is the culprit, although the chief suspect is aegeline. When USPlabs was forced to remove the stimulant dimethylamylamine (DMAA) from OEP in early 2013, they substituted, among other ingredients, synthetic aegeline, which occurs naturally in the Asian bael tree. Aegeline is billed as a stimulant and appetite suppressant, but what it really does is unknown because it has never been studied in humans. Debated is why so many of the cases (nearly 50) were in Hawaii. A "bad batch" of OEP seems unlikely. A genetic predisposition among Hawaiians is possible. Maybe the explanation is that, thanks to an astute liver transplant surgeon, Hawaii became the canary in the coal mine. Craze: Gone Today, Here Tomorrow? The Craze story shows how, for the FDA, dietary supplements are moving targets. To quote the award-winning USA Today series, The Shell Game: "A number of supplement firms caught with drug-spiked products are run by executives with criminal backgrounds and regulatory run-ins." This applies to USPlabs (above) and to Driven Sports, which makes the preworkout supplement Craze (17). Craze appeared in 2011, promising "endless energy." It was sold fast. In 2012, it was named "New Supplement of the Year" by Bodybuilding.com (1). Then several top athletes failed urine tests because of a methamphetamine analog. They blamed it on Craze. Also, a father told the FDA that his son took Craze, was found unresponsive, and tested positive for "amphetamine" in the hospital. Craze is touted as containing the essence of dendrobium orchids. However, credible laboratories find that it is spiked with a new "designer-drug" methamphetamine analog (5). Driven Sports denies that Craze contained a methamphetamine analog but, under threat from the FDA, quit distributing Craze and said it would destroy stockpiles. Then in April 2014, Driven Sports launched the preworkout supplement Frenzy, claiming to sell it only "outside" the United States. Frenzy is sold by a European Internet firm, Predator Nutrition, that may ship it to the United States. Users who review Frenzy on the Internet rave about its stimulatory effects, similar to Craze. So far, Driven Sports will not say what is in Frenzy (18). Is it Craze redux? The pearl: The dietary supplement industry is indeed a shell game. Snake oil supplements are poorly regulated, the robbers are one step ahead of the cops, the outgunned FDA plays Whac-A-Mole, and the consumers are the guinea pigs. As Pieter Cohen, MD, has recently proposed in detail, we need a far better system to guard the health and lives of Americans (4).