Acute liver injury due to flavocoxid (Limbrel), a medical food for osteoarthritis: a case series.
BACKGROUND
Flavocoxid is a prescription medical food that is used to treat osteoarthritis. It is a proprietary blend of 2 flavonoids, baicalin and catechins, which are derived from the botanicals Scutellaria baicalensis and Acacia catechu, respectively.


OBJECTIVE
To describe characteristics of patients with acute liver injury suspected of being caused by flavocoxid.


METHODS
Case series.


METHODS
Drug-Induced Liver Injury Network Prospective Study ongoing at multiple academic medical centers since 2004.


METHODS
Four adults with liver injury.


METHODS
Clinical characteristics, liver biochemistry values, and outcomes.


RESULTS
Among 877 patients enrolled in the prospective study, 4 had liver injury suspected to have been caused by flavocoxid. All were women; ages ranged from 57 to 68 years. All developed symptoms and signs of liver injury within 1 to 3 months after initiating flavocoxid. Liver injury was characterized by marked elevations in levels of alanine aminotransferase (mean peak, 1268 U/L; range, 741 to 1540 U/L), alkaline phosphatase (mean peak, 510 U/L; range, 286 to 770 U/L), and serum bilirubin (mean peak, 160.7 µmol/L [9.4 mg/dL]; range, 34.2 to 356 µmol/L [2.0 to 20.8 mg/dL]). Liver biochemistry values decreased to the normal range within 3 to 12 weeks after flavocoxid was stopped, and all patients recovered without experiencing acute liver failure or chronic liver injury. Causality was adjudicated as highly likely in 3 patients and as possible in 1 patient.


CONCLUSIONS
The frequency and mechanism of liver injury could not be assessed.


CONCLUSIONS
Flavocoxid can cause clinically significant liver injury, which seems to resolve within weeks after cessation.
Division of Gastroenterology and Hepatology, Indiana University School of Medicine, 1050 Wishard Boulevard, RG 4100, Indianapolis, IN 46202, USA. nchalasa@iupui.edu
Naga
N
Chalasani
Raj
R
Vuppalanchi
Victor
V
Navarro
Robert
R
Fontana
Herbert
H
Bonkovsky
Huiman
H
Barnhart
David E
DE
Kleiner
Jay H
JH
Hoofnagle
D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D000469:Alkaline Phosphatase / Q000097:blood; D001663:Bilirubin / Q000097:blood; D002392:Catechin / Q000009:adverse effects*; D056486:Chemical and Drug Induced Liver Injury / Q000201:enzymology / Q000209:etiology*; D019587:Dietary Supplements / Q000009:adverse effects*; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008875:Middle Aged; D010003:Osteoarthritis / Q000188:drug therapy*; D011446:Prospective Studies
D004338:Drug Combinations; C544478:flavocoxid; D002392:Catechin; D000410:Alanine Transaminase; D000469:Alkaline Phosphatase; D001663:Bilirubin