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Wednesday, July 11, 2012 The Chronicle-Express

Arthritis treatment linked to liver problems in study

But its unclear why medical food called Limbrel might make patients sick
By Randy Dotinga HealthDay Reporter A "medical food" called Limbrel, which doctors prescribe to treat osteoarthritis of the knee, was linked to several cases of liver disease in a small study, but the effects so far seem to be rare and easily reversible. Still, patients who take Limbrel, also known as avocoxid, should be aware of the potential for liver problems, said study lead author Dr. Naga Chalasani, director of the division of gastroenterology and hepatology at Indiana University School of Medicine, in Indianapolis. Patients should not assume that "medical foods," such as Limbrel, are 100 percent safe, he added. In the United States, medical foods are not subjected to the clinical trials required of prescription drugs before coming to market. According to Primus Pharmaceuticals,, Inc., maker of Limbrel, the main ingredients of the pills are plant elements known as bioavonoids, specically baicalin and catechins. The company says Limbrel helps improve mobility and relieve joint discomfort and stiffness related to arthritis. For the new study, Chalasani and colleagues analyzed 877 cases of liver injury, and found four linked with Limbrel. The researchers said it's "highly likely" that the product caused the liver problems in three of the patients and possible in the other one. Symptoms included nausea, drugs, including all anti-inammatory agents, are known to have some liver toxicity," Levy said. Painkillers, another common treatment for osteoarthritis, only provide limited relief, and are also associated with adverse events, the study authors said. About 20 million Americans suffer from osteoarthritis, which is the leading cause of disability in the United States, according to the U.S. National Institutes of Health. Study lead author Chalasani said patients and physicians should be aware that medical food products haven't gone fatigue, and yellow skin, Chathrough the same kind of review lasani said. The four patients as regular prescription drugs. were women between 57 and 68 "I'll bet most people who preyears old who showed signs of scribe Limbrel think it's gone liver illness between one and through the typical review three months after taking Limprocess," he said. "If a physician brel. chooses to prescribe Limbrel, he They recovered within weeks or she should be aware that it of discontinuing the drug. can cause this toxicity." If pa"Our report provides convinctients develop symptoms of liver ing evidence that avocoxid is damage, they should stop taking capable of causing clinically apLimbrel, he added. parent, acute liver injury," the The study appears in the study authors wrote. They also June 19 issue of the Annals of noted that the pharmaceutical Internal Medicine. company has discovered 31 posThe authors of an accompanysible cases of liver problems ing journal editorial said that among more than 284,000 users the current policy of allowing since the drug was brought to medical foods to come to market market in 2004. without rigorous testing may It's not clear why Limbrel need to be reconsidered, given might cause liver problems, altheir popularity and potential though the researchers suspect for damage. one of its chemicals may be at More information: fault, Chalasani said. The U.S. Food and Drug AdAccording to Dr. Robert Levy, ministration has more about director of clinical development medical foods. for Primus Pharmaceuticals, SOURCES: Naga Chalasani, "Limbrel is, by far, the safest M.D., director, division of gasanti-inammatory on the martroenterology and hepatology, ket." Indiana University School of Limbrel has an "extraordiMedicine, Indianapolis; Robert nary safety prole," he added. M. Levy, M.D., director of cliniHe said medical foods must be cal development, Primus Pharprescribed and used under the maceuticals, Scottsdale, Ariz.; direction of a physician, adding June 19, 2012, Annals of Interthat physicians should monitor nal Medicine the livers of patients who take Last Updated: June 18, 2012 the drugs. Copyright 2012 HealthDay. "Because the liver is the site All rights reserved. of metabolism of most drugs and foreign chemicals, a great many


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