Acute Liver Injury due to Flavocoxid (Limbrel), a Medical Food for Osteoarthritis

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 mu mol/L [9.4 mg/dL]; range, 34.2 to 356 mu mol/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.