Flora Or1, Yongjoo Kim2, Juliana Simms3, S Bryn Austin4. 1. Department of Social and Behavioral Sciences, Harvard T.H. Chan School of Public Health, Boston, Massachusetts. Electronic address: jfo256@mail.harvard.edu. 2. Department of Social and Behavioral Sciences, Harvard T.H. Chan School of Public Health, Boston, Massachusetts. 3. Harvard University Information Technology, Cambridge, Massachusetts. 4. Department of Social and Behavioral Sciences, Harvard T.H. Chan School of Public Health, Boston, Massachusetts; Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, Boston, Massachusetts.
Abstract
PURPOSE: The aim of the study was to evaluate the relationship between supplement categories and adverse events in children, adolescents, and young adults. METHODS: This is a retrospective observational study using adverse event reports between January 2004 and April 2015 in the U.S. Food and Drug Administration Adverse Event Reporting System on food and dietary supplements database. We quantified the relative risks for severe medical events of dietary supplements sold for various functions relative to vitamins among individuals aged between 0 and 25 years. Severe medical events include death, disability, life-threatening events, hospitalization, emergency room visit, and/or required intervention to prevent permanent disability. RESULTS: There were 977 single-supplement-related adverse event reports affecting individuals aged between 0 and 25 years over 11 years (50.6% female; age: mean = 16.5 years, standard deviation = 7.5 years). Supplements sold for muscle building (risk ratio [RR] = 2.7; 95% confidence interval [CI] = 1.9-4.0), energy (RR = 2.6; 95% CI = 1.9-3.6), and weight loss (RR = 2.6; 95% CI = 1.9-3.4) were associated with almost three times the risk for severe medical events compared with vitamins. CONCLUSIONS: Consumption of dietary supplements sold for weight loss, muscle building, and energy involved increased risks for severe medical events compared with vitamins. Proactive enforcement of regulations is needed to reduce access and consumption among children, adolescents, and young adults.
PURPOSE: The aim of the study was to evaluate the relationship between supplement categories and adverse events in children, adolescents, and young adults. METHODS: This is a retrospective observational study using adverse event reports between January 2004 and April 2015 in the U.S. Food and Drug Administration Adverse Event Reporting System on food and dietary supplements database. We quantified the relative risks for severe medical events of dietary supplements sold for various functions relative to vitamins among individuals aged between 0 and 25 years. Severe medical events include death, disability, life-threatening events, hospitalization, emergency room visit, and/or required intervention to prevent permanent disability. RESULTS: There were 977 single-supplement-related adverse event reports affecting individuals aged between 0 and 25 years over 11 years (50.6% female; age: mean = 16.5 years, standard deviation = 7.5 years). Supplements sold for muscle building (risk ratio [RR] = 2.7; 95% confidence interval [CI] = 1.9-4.0), energy (RR = 2.6; 95% CI = 1.9-3.6), and weight loss (RR = 2.6; 95% CI = 1.9-3.4) were associated with almost three times the risk for severe medical events compared with vitamins. CONCLUSIONS: Consumption of dietary supplements sold for weight loss, muscle building, and energy involved increased risks for severe medical events compared with vitamins. Proactive enforcement of regulations is needed to reduce access and consumption among children, adolescents, and young adults.
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