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Ann Intern Med. 2012 Jun 19;156(12):857-60, W297-300. doi: 10.7326/0003-4819-156-12-201206190-00006.

Acute liver injury due to flavocoxid (Limbrel), a medical food for osteoarthritis: a case series.

Author information

1
Division of Gastroenterology and Hepatology, Indiana University School of Medicine, 1050 Wishard Boulevard, RG 4100, Indianapolis, IN 46202, USA. nchalasa@iupui.edu

Abstract

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.

DESIGN:

Case series.

SETTING:

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

PATIENTS:

Four adults with liver injury.

MEASUREMENTS:

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 ┬Ámol/L [9.4 mg/dL]; range, 34.2 to 356 ┬Ámol/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.

LIMITATION:

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

CONCLUSION:

Flavocoxid can cause clinically significant liver injury, which seems to resolve within weeks after cessation.

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