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Acute liver injury due to flavocoxid (Limbrel), a medical food for osteoarthritis: a case series.
Ann Intern Med. 2012 Jun 19; 156(12):857-60, W297-300.AIM

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 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.

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.

Authors+Show Affiliations

Division of Gastroenterology and Hepatology, Indiana University School of Medicine, 1050 Wishard Boulevard, RG 4100, Indianapolis, IN 46202, USA. nchalasa@iupui.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, N.I.H., Extramural
Research Support, N.I.H., Intramural

Language

eng

PubMed ID

22711078

Citation

Chalasani, Naga, et al. "Acute Liver Injury Due to Flavocoxid (Limbrel), a Medical Food for Osteoarthritis: a Case Series." Annals of Internal Medicine, vol. 156, no. 12, 2012, pp. 857-60, W297-300.
Chalasani N, Vuppalanchi R, Navarro V, et al. Acute liver injury due to flavocoxid (Limbrel), a medical food for osteoarthritis: a case series. Ann Intern Med. 2012;156(12):857-60, W297-300.
Chalasani, N., Vuppalanchi, R., Navarro, V., Fontana, R., Bonkovsky, H., Barnhart, H., Kleiner, D. E., & Hoofnagle, J. H. (2012). Acute liver injury due to flavocoxid (Limbrel), a medical food for osteoarthritis: a case series. Annals of Internal Medicine, 156(12), 857-60, W297-300. https://doi.org/10.7326/0003-4819-156-12-201206190-00006
Chalasani N, et al. Acute Liver Injury Due to Flavocoxid (Limbrel), a Medical Food for Osteoarthritis: a Case Series. Ann Intern Med. 2012 Jun 19;156(12):857-60, W297-300. PubMed PMID: 22711078.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Acute liver injury due to flavocoxid (Limbrel), a medical food for osteoarthritis: a case series. AU - Chalasani,Naga, AU - Vuppalanchi,Raj, AU - Navarro,Victor, AU - Fontana,Robert, AU - Bonkovsky,Herbert, AU - Barnhart,Huiman, AU - Kleiner,David E, AU - Hoofnagle,Jay H, PY - 2012/6/20/entrez PY - 2012/6/20/pubmed PY - 2012/8/21/medline SP - 857-60, W297-300 JF - Annals of internal medicine JO - Ann. Intern. Med. VL - 156 IS - 12 N2 - 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 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. 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. SN - 1539-3704 UR - https://www.unboundmedicine.com/medline/citation/22711078/Acute_liver_injury_due_to_flavocoxid__Limbrel__a_medical_food_for_osteoarthritis:_a_case_series_ L2 - https://www.annals.org/aim/fullarticle/doi/10.7326/0003-4819-156-12-201206190-00006 DB - PRIME DP - Unbound Medicine ER -