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

ABSTRACT

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.

KEYWORDS:

• Biostatistics
• item response theory
• mixed models
• pharmacoepidemiology

AMS SUBJECT CLASSIFICATION:

• 62P10

Acknowledgments

The author has served as an expert witness in a lawsuit related to OxyELITE Pro and hepatitis and liver failure. USPLabs was not involved in any of the research related to this article or analysis of the medical claims data used in this study and did not review the results of the article prior to submission for publication. The data were purchased from Truven Health by USPLabs as a part of their litigation.