Study: “Medical Food” Could Cause Liver Disease

A “medical food” called Limbrel, which doctors prescribe to treat osteoarthritis of the knee, has been linked to several cases of liver disease in a small study. The effects seem to be rare and easily reversible, but patients should be aware of the potential for harm.

The “medical food” is marketed as Limbrel, also known as flavocoxid. Doctors and patients 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. Primus Pharmaceuticals Inc., maker of Limbrel, said 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.

In the United States, medical foods are not subjected to the clinical trials required of prescription drugs.

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 of age. They showed signs of liver illness between one and three months after taking Limbrel, but they recovered within weeks of discontinuing the use of Limbrel.

The study authors noted that the pharmaceutical company has discovered 31 possible cases of liver problems among more than 284,000 users since Limbrel was brought to market in 2004. It’s not clear why Limbrel might cause liver problems, although the researchers suspect one of its chemicals may be at fault, Chalasani said.

According to Dr. Robert Levy, director of clinical development for Primus Pharmaceuticals, “Limbrel is, by far, the safest anti-inflammatory on the market.” Limbrel has an “extraordinary safety profile,” he added. He said medical foods must be prescribed and used under the direction of a physician, adding that physicians should monitor the livers of patients who take the drugs.

“Because the liver is the site of metabolism of most drugs and foreign chemicals, a great many drugs, including all anti-inflammatory agents, are known to have some liver toxicity,” Levy 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. The study appears in the June 19 issue of the Annals of Internal Medicine.

Kreisman Law Offices has been handling Illinois medical malpractice matters for individuals and families for more than 40 years in and around Chicago, Cook County and surrounding areas, including Hillside, Tinley Park, Downers Grove, Prospect Heights, and Des Plaines, Ill.