MONDAY, June 18 (HealthDay News) -- 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 flavocoxid, 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 bioflavonoids, specifically 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, fatigue and yellow skin, Chalasani said. The four patients were women between 57 and 68 years old who showed signs of liver illness between one and three months after taking Limbrel.
They recovered within weeks of discontinuing the drug.
"Our report provides convincing evidence that flavocoxid is capable of causing clinically apparent, acute liver injury," the study authors wrote. They also noted that the pharmaceutical company has discovered 31 possible cases of liver problems among more than 284,000 users since the dru
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