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 drug 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.
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 through the same kind of review as
regular prescription drugs.
“I’ll bet most people who prescribe Limbrel think it’s gone through the
typical review process,” he said. “If a physician chooses to prescribe
Limbrel, he or she should be aware that it can cause this toxicity.” If
patients develop symptoms of liver damage, they should stop taking
Limbrel, he added.
The study appears in the June 19 issue of the Annals of Internal
Medicine.
The authors of an accompanying journal editorial said that the current
policy of allowing medical foods to come to market without rigorous
testing may need to be reconsidered, given their popularity and potential
for damage.
More information
The U.S. Food and Drug Administration has more about medical foods.