Caffeinated energy drinks: adverse event reports to the US Food and Drug Administration and the National Poison Data System, 2008 to 2015

• Published in: Public health nutrition 2019-10, Vol.22 (14), p.2531-2542
• Main Authors: Markon, André O, Jones, Olivia E, Punzalan, Cecile M, Lurie, Peter, Wolpert, Beverly
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Adverse Drug Reaction Reporting Systems - statistics & numerical data; Aged; Aged, 80 and over; Beverages; Caffeine; Caffeine - adverse effects; Central Nervous System Stimulants - adverse effects; Child; Consumer protection; Consumers; Cross-Sectional Studies; Drug-Related Side Effects and Adverse Reactions - epidemiology; Drug-Related Side Effects and Adverse Reactions - etiology; Energy Drinks - adverse effects; Exposure; Female; Humans; Male; Middle Aged; Nutrition; Poison Control Centers; Product names; Public health; Research Paper; United States - epidemiology; United States Food and Drug Administration; Young Adult; Young adults
• ISSN: 1368-9800; 1475-2727
• DOI: 10.1017/S1368980019001605

To describe and compare caffeinated energy drink adverse event (AE) report/exposure call data from the US Food and Drug Administration Center for Food Safety and Applied Nutrition's Adverse Event Reporting System (CAERS) and the American Association of Poison Control Centers' National Poison Data System (NPDS). Cross-sectional. Data were evaluated from US-based CAERS reports and NPDS exposure calls, including report/exposure call year, age, sex, location, single v. multiple product consumption, outcome, symptom, intentionality (NPDS only), report type, product name (CAERS only). The analysis defined participants (cases) by the number of caffeinated energy drink products indicated in each AE report or exposure call. Single product cases included 357 from CAERS and 12 822 from NPDS; multiple product cases included 153 from CAERS and 931 from NPDS. CAERS v. NPDS single product cases were older and more frequently indicated serious symptoms. Multiple v. single product consumers were older in both. In CAERS, unlike NPDS, most multiple product consumers were female. CAERS single v. multiple product reports cited higher proportions of life-threatening events, but less often indicated hospitalization and serious events. NPDS multiple v. single product cases involved fewer ≤5-year-olds and were more often intentional. Despite limitations, both data sources contribute to post-market surveillance and improve understanding of public health concerns.