The Role of Adverse Event Reporting in the FDA Response to a Multistate Outbreak of Liver Disease Associated with a Dietary Supplement.
OBJECTIVE
Liver disease is a potential complication from using dietary supplements. This study investigated an outbreak of non-viral liver disease associated with the use of OxyELITE Pro(TM), a dietary supplement used for weight loss and/or muscle building.


METHODS
Illness details were ascertained from MedWatch reports submitted to the U.S. Food and Drug Administration (FDA) describing consumers who ingested OxyELITE Pro alone or in combination with other dietary supplements. FDA's Forensic Chemistry Center analyzed samples of OxyELITE Pro.


RESULTS
From February 2012 to February 2014, FDA received 114 reports of adverse events of all kinds involving consumers who ingested OxyELITE Pro. The onset of illness for the first report was December 2010 and for the last report was January 2014. Thirty-three states, two foreign nations, and Puerto Rico submitted reports. Fifty-five of the reports (48%) described liver disease in the absence of viral infection, gallbladder disease, autoimmune disease, or other known causes of liver damage. A total of 33 (60%) of these patients were hospitalized, and three underwent liver transplantation. In early 2013, OxyELITE Pro products entered the market with a formulation distinct from products sold previously. The new formulation replaced 1,3-dimethylamylamine with aegeline. However, the manufacturer failed to submit to FDA a required "new dietary ingredient" notice for the use of aegeline in OxyELITE Pro products. Laboratory analysis identified no drugs, poisons, pharmaceuticals, toxic metals, usnic acid, N-Nitroso-fenfluramine, pyrrolizidine alkaloids, aristocholic acid, or phenethylamines in the products.


CONCLUSIONS
Vigilant surveillance is required for adverse events linked to the use of dietary supplements.
U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Analytics and Outreach, College Park, MD.
Karl C
KC
Klontz
U.S. Food and Drug Administration, Office of Foods and Veterinary Medicine, Coordinated Outbreak Response and Evaluation Network, College Park, MD.
Heidi J
HJ
DeBeck
U.S. Food and Drug Administration, Office of Foods and Veterinary Medicine, Coordinated Outbreak Response and Evaluation Network, College Park, MD.
Pamela
P
LeBlanc
U.S. Food and Drug Administration, Office of Regulatory Affairs, Silver Spring, MD.
Kathryn M
KM
Mogen
U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Analytics and Outreach, College Park, MD.
Beverly J
BJ
Wolpert
U.S. Food and Drug Administration, Center for Veterinary Medicine, Office of Research, Laurel, MD.
Jonathan L
JL
Sabo
U.S. Food and Drug Administration, Office of Foods and Veterinary Medicine, Coordinated Outbreak Response and Evaluation Network, College Park, MD.
Monique
M
Salter
U.S. Food and Drug Administration, Office of Foods and Veterinary Medicine, Coordinated Outbreak Response and Evaluation Network, College Park, MD.
Sharon L
SL
Seelman
U.S. Food and Drug Administration, Office of Foods and Veterinary Medicine, Coordinated Outbreak Response and Evaluation Network, College Park, MD.
Susan E
SE
Lance
U.S. Food and Drug Administration, Office of Foods and Veterinary Medicine, Coordinated Outbreak Response and Evaluation Network, College Park, MD.
Caitlin
C
Monahan
U.S. Food and Drug Administration, Office of Foods and Veterinary Medicine, Coordinated Outbreak Response and Evaluation Network, College Park, MD.
David S
DS
Steigman
U.S. Food and Drug Administration, Office of Foods and Veterinary Medicine, Coordinated Outbreak Response and Evaluation Network, College Park, MD.
Kathleen
K
Gensheimer
D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence*; D000577:Amides / Q000506:poisoning*; D000588:Amines / Q000506:poisoning*; D019440:Anti-Obesity Agents / Q000506:poisoning; D056486:Chemical and Drug Induced Liver Injury / Q000453:epidemiology* / Q000209:etiology / Q000601:surgery; D002626:Chemistry, Pharmaceutical / Q000331:legislation & jurisprudence; D019587:Dietary Supplements / Q000506:poisoning*; D004196:Disease Outbreaks / Q000706:statistics & numerical data; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005260:Female; D006254:Hawaii / Q000453:epidemiology; D006801:Humans; D017114:Liver Failure, Acute / Q000139:chemically induced* / Q000401:mortality; D016031:Liver Transplantation / Q000706:statistics & numerical data; D008297:Male; D008875:Middle Aged; D011159:Population Surveillance / Q000379:methods; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*; D055815:Young Adult
C571979:1,3-dimethylamylamine; D000577:Amides; D000588:Amines; D019440:Anti-Obesity Agents; C560978:aegeline