Naga Chalasani, MD; Raj Vuppalanchi, MD; Victor Navarro, MD; Robert Fontana, MD; Herbert Bonkovsky, MD; Huiman Barnhart, PhD; David E. Kleiner, MD; Jay H. Hoofnagle, MD; on behalf of the Drug-Induced Liver Injury Network
Acknowledgment: The authors thank Primus Pharmaceuticals and Dr. Robert Levy, Chief Medical Officer, for providing the case histories reported to them of 8 patients with suspected flavocoxid-induced liver injury.
Financial Support: The DILIN is supported by the National Institute of Diabetes and Digestive and Kidney Diseases (https://dilin.dcri.duke.edu/). This research was supported in part by the Intramural Research Program of the National Cancer Institute, National Institutes of Health.
Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M12-0176.
Reproducible Research Statement: The authors are willing to provide the narratives and laboratory data of the cases reported in this paper to the interested public.
Requests for Single Reprints: Naga Chalasani, MD, Division of Gastroenterology and Hepatology, Indiana University School of Medicine, 1050 Wishard Boulevard, RG 4100, Indianapolis, IN 46202; e-mail, mailto:firstname.lastname@example.org.
Current Author Addresses: Drs. Chalasani and Vuppalanchi: Division of Gastroenterology and Hepatology, Indiana University School of Medicine, 1050 Wishard Boulevard, RG 4100, Indianapolis, IN 46202.
Dr. Navarro: Thomas Jefferson University, Main Building, Suite 480, 132 South 10th Street, Philadelphia, PA 19107.
Dr. Fontana: University of Michigan, Alfred Taubman Health Care Center, 1500 East Medical Center Drive, Floor 3, Reception D, Room 3326, Ann Arbor, MI 48109-5362.
Dr. Bonkovsky: Carolinas HealthCare System, Suite 201, Cannon Research Center, 1542 Garden Terrace, Charlotte, NC 28203.
Dr. Barnhart: Duke University, Duke Box 3850, Durham, NC 27710.
Dr. Kleiner: National Cancer Institute, Building 10, Magnuson CC, Room 2B44, 10 Center Drive, Bethesda, MD 20892.
Dr. Hoofnagle: National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Building 31, Room 9A27, Bethesda, MD 20892.
Author Contributions: Conception and design: N. Chalasani, R. Vuppalanchi, H. Bonkovsky, J.H. Hoofnagle.
Analysis and interpretation of the data: N. Chalasani, V. Navarro, R. Fontana, H. Bonkovsky, H. Barnhart, D.E. Kleiner, J.H. Hoofnagle.
Drafting of the article: N. Chalasani, R. Fontana, H. Bonkovsky, H. Barnhart.
Critical revision of the article for important intellectual content: N. Chalasani, V. Navarro, H. Bonkovsky, D.E. Kleiner, J.H. Hoofnagle.
Final approval of the article: N. Chalasani, V. Navarro, R. Fontana, H. Bonkovsky, H. Barnhart, D.E. Kleiner, J.H. Hoofnagle.
Provision of study materials or patients: N. Chalasani, R. Vuppalanchi, V. Navarro, R. Fontana, H. Bonkovsky.
Statistical expertise: H. Barnhart.
Obtaining of funding: N. Chalasani, H. Bonkovsky, H. Barnhart.
Administrative, technical, or logistic support: J.H. Hoofnagle.
Collection and assembly of data: N. Chalasani, R. Vuppalanchi, R. Fontana, D.E. Kleiner, J.H. Hoofnagle.
Chalasani N, Vuppalanchi R, Navarro V, Fontana R, Bonkovsky H, Barnhart H, et al. Acute Liver Injury due to Flavocoxid (Limbrel), a Medical Food for Osteoarthritis: A Case Series. Ann Intern Med. 2012;156:857-860. doi: 10.7326/0003-4819-156-12-201206190-00006
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Published: Ann Intern Med. 2012;156(12):857-860.
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.
To describe characteristics of patients with acute liver injury suspected of being caused by flavocoxid.
Drug-Induced Liver Injury Network Prospective Study ongoing at multiple academic medical centers since 2004.
Four adults with liver injury.
Clinical characteristics, liver biochemistry values, and outcomes.
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.
The frequency and mechanism of liver injury could not be assessed.
Flavocoxid can cause clinically significant liver injury, which seems to resolve within weeks after cessation.
National Institute of Diabetes and Digestive and Kidney Diseases.
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Gastroenterology/Hepatology, Rheumatology, Liver Disease, Osteoarthritis.
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