The Food and Drug Administration (FDA) has urged Primus Pharmaceuticals to recall Limbrel, a product designed to treat the “metabolic processes associated with osteoarthritis.” The agency says the product comes with a risk of lung and liver injury.
The company markets Limbrel as a “medical food,” but the FDA this week says it considers the product an unapproved drug.
While the agency is urging Primus to pull the product off shelves, it cannot require a recall.
The FDA issued a warning last month asking users to stop taking Limbrel immediately and that it was in the process of investigating “adverse events” that may be associated with the product.
“The U.S. Food and Drug Administration is advising consumers not to use Limbrel, a product in capsule form currently being manufactured as a medical food to manage the metabolic processes associated with osteoarthritis,” the FDA said in a statement. “If you are currently using it, stop taking it immediately and contact your health care provider.”
A total of 194 adverse events were reported about the product, and 30 were found to be likely associated with Limbrel.
Those with liver injury were reporting symptoms of nausea, fatigue and jaundice. Those with hypersensitivity pneumonitis, a lung condition, said they had experienced coughing, fevers and difficulty breathing.
Limbrel is available in two dosages: Limbrel500 and Limbrel250. According to the product’s label, Limbrel contains two flavonoids: catechin and baicalin. The product also contains zinc.
The FDA noted that it asked Primus to recall the product on November 30, but the company has yet to take Limbrel off the market.
According to Primus, Limbrel – available with a prescription – helps improve mobility in patients suffering with osteoarthritis.
In its warning last month, the FDA asked medical providers to provide clinical information about Limbrel through the MedWatch Safety Information and Adverse Event Reporting Program.