The REAL Cause of Non Alcoholic Fatty Liver Disease (NAFLD)
Liver Risk Found with Arthritis Supplement
Acute liver injury likely or possibly caused by the supplement flavocoxid, which is used to treat osteoarthritis, study shows.
By Kristina Fiore, MedPage Today
Medically Reviewed byDori F Zaleznik, MD
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TUESDAY, June 19, 2012 (MedPage Today) —A botanical product sold as help for osteoarthritis may carry risk of liver injury, researchers found.
In a prospective study, flavocoxid (Limbrel) was associated with four cases of liver injury that halted once the agent was discontinued, Naga Chalasani, MD, of Indiana University in Indianapolis, and colleagues reported in the June 19 issue of theAnnals of Internal Medicine.
Flavocoxid is a blend of two flavonoids, baicalin and catechins, which are derived from the botanicalsScute-Ilaria baicalensisandAcacia catechu. It is available only by prescription as 250- or 500-mg tablets to treat osteoarthritis.
To assess whether it was associated with adverse liver effects, the researchers looked at data from 877 patients enrolled in the Drug-Induced Liver Injury Network Prospective Study since 2004. They found that four patients had liver injury that was suspected to have been caused by flavocoxid.
All cases occurred in women ranging in age from 57 to 68 years, and all developed symptoms and signs of liver injury within one to three months after starting on flavocoxid. Symptoms included jaundice, pruritus, abdominal pain, fever, and rash, the researchers said.
All of the patients had marked elevations in alanine aminotransferase, alkaline phosphatase, and serum bilirubin.
All of these values fell back into the normal range within 3 to 12 weeks of stopping the product, and all patients recovered without having acute liver failure or chronic liver injury, Chalasani and colleagues noted.
Causality was called very likely due to flavocoxid in three patients and possibly due to the agent in one patient, as that case was complicated by exposure to several other agents that may have caused the injury, including pregabalin (Lyrica), duloxetine (Cymbalta), and tizanidine (Zanaflex).
The researchers noted that post-marketing studies by drugmaker Primus Pharmaceuticals showed 31 hepatic adverse events among 284,399 users, suggesting a possible incidence of about 0.011 percent of flavocoxid-induced liver injury.
That included 22 instances of elevated liver enzyme levels, six instances of jaundice, and three cases of hepatitis.
Chalasani and colleagues concluded that the report "provides convincing evidence that flavocoxid is capable of causing clinically apparent, acute liver injury," noting that the clinical signature appears to be a "mild-to-moderate, mixed hepatocellular-cholestatic hepatitis that arises 2 to 12 weeks after starting the medication and resolves rapidly once it is stopped."
They also suspected that hypersensitivity may play a role, because immunoallergic features occurred in some patients, and because flavocoxid is also associated with hypersensitivity pneumonitis.
The study was limited because the frequency, risk factors, and mechanism of liver injury couldn't be assessed.
In an accompanying editorial, Stephan Reichenbach, MD, and Peter Juni, MD, of the University of Bern in Switzerland, wrote that exact estimates on the frequency of serious adverse events among patients on herbal products are usually underreported because patients don't consider them as toxic and rarely report their use.
Given the widespread use and potential harm of medical food and food supplements, they wrote, the lack of a requirement of FDA approval for these agents should be reconsidered.
Video: फैटी लिवर की सच्चाई (Hindi) FATTY LIVER SECRETS Explained by Dr.Education | NAFLD | NASH | Cirrhosis
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