Journal of Statistical Theory and Practice

, Volume 12, Issue 1, pp 42–47 | Cite as

OxyELITE Pro and liver disease: Statistical assessment of an apparent association

  • Robert D. GibbonsEmail author


The Centers for Disease Control and Prevention (CDC) identified an outbreak of acute hepatitis and liver failure in Hawaii in which a large proportion of patients were using the dietary supplement OxyELITE Pro, which contained aegeline, an extract from the bael tree and fruit. In response to Food and Drug Administration (FDA) regulatory action, USPLabs voluntarily recalled all OxyELITE Pro products and destroyed its remaining stock. To date, the majority of attention has focused on Hawaii despite the fact that the majority of the sales were in the mainland United States. Rates of acute hepatitis and liver failure were compared in equivalent 10-month periods before and after the introduction of aegeline to the product in the entire United States, prior to media attention related to the reported outbreak. The association between sales and liver injury was examined at the state level. Claims for ICD-9 code 570 (acute necrosis of the liver) obtained from both private insurance claims (MarketScan) and Medicaid were analyzed using mixed-effects Poisson regression models. Patients with private health insurance revealed a significant decrease in rates of acute hepatitis and liver failure following the introduction of aegeline in the United States and no association with per-capita sales. Patients with Medicaid showed no change in rate of acute hepatitis and liver failure following the introduction of aegeline. These data do not support the association between aegeline and acute hepatitis and liver failure suggested by the data in Hawaii and a small number of spontaneous adverse reports in the mainland United States.


Biostatistics item response theory mixed models pharmacoepidemiology 

AMS Subject Classification



Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. Gibbons, R. D., and A. Amatya. 2015. Statistical methods for drug safety. London, UK: Chapman and Hall.Google Scholar
  2. Hedeker, D., and R. D. Gibbons. 2006. Longitudinal data analysis. New York, NY: Wiley.zbMATHGoogle Scholar
  3. Johnston, D. I., A. Chang, M. Viray, K. Chatham-Stephens, H. He, E. Taylor, L. L. Wong, J. Schier, C. Martin, D. Fabricant, M. Salter, L. Lewis, and S. Y. Park. 2016. Hepatotoxicity associated with the dietary supplement OxyELITE Pro™ — Hawaii, 2013. Drug Testing and Analysis 8:319–327. doi:10.1002/dta.l894.CrossRefGoogle Scholar
  4. Klontz, K. C., H. J. DeBeck, P. LeBlanc, K. M. Mogen, B. J. Wolpert, J. L. Sabo, M. Salter, S. L. Seelman, S. E. Lance, C. Monahan, D. S. Steigman, and K. Gensheimer. 2015. The role of adverse event reporting in the FDA response to a multistate outbreak of liver disease associated with a dietary supplement. Public Health Reports 130 (5):526–32. doi:10.1177/003335491513000515.CrossRefGoogle Scholar
  5. Park, S. Y., M. Viray, and D. Johnston. 2013. Note from the field: Acute hepatitis and liver failure following the use of dietary supplement intended for weight loss or muscle building. Morbidity and Mortality Weekly Report 62 (40):817–19.Google Scholar
  6. Roytman, M. M., P. Porzgen, C. L. Lee, L. Huddleston, T. T. Kuo, P. Bryant-Greenwood, L. L. Wong, and N. Tsai. 2014. Outbreak of severe hepatitis linked to weight-loss supplement OxyELITE Pro. American Journal of Gastroenterology 109 (8):1296–98. doi:10.1038/ajg.2014.159.CrossRefGoogle Scholar

Copyright information

© Grace Scientific Publishing, 20 Middlefield Ct, Greensboro, NC 27455 2018

Authors and Affiliations

  1. 1.Departments of Medicine and Public Health Sciences (Biostatistics), and Center for Health StatisticsUniversity of ChicagoChicagoUSA

Personalised recommendations