The FDA is investigating the drug Limbrel, a capsule-based product currently marketed as a medical food to manage the metabolic processes associated with osteoarthritis, for what the administration calls “serious adverse events.”
Limbrel (flavocoxid, Primus Pharmaceuticals) has been linked to a total of 194 of adverse events, including two “serious and potentially life-threatening” medical conditions — drug-induced liver injury and hypersensitivity pneumonitis — according to an FDA statement. Of the nearly 200 adverse events, 57 cases included sufficient information to determine whether there was a link to Limbrel, the administration said.
In 30 cases, there was enough information to use the Council for International Organizations of Medical Sciences’ causality assessment method to determine the likelihood of an association between Limbrel consumption and the reported adverse events.
In response to the investigation, the FDA has issued the following recommendations:
- Health care professionals who are aware of patients taking Limbrel should advise them to immediately stop taking the product.
- Consumers taking Limbrel should immediately stop and contract their health care provider.
If patients experience any of the aforementioned symptoms or other health problems while taking Limbrel, health care providers should work with them to provide clinical information through MedWatch, the FDA said.
Limbrel is currently available in 250 mg and 500 mg dosages. According to the FDA, the product labeling states that it contains two types of flavonoids — baicalin (from Scutellaria baicalensis) and catechin (from Acacia catechu). Both dosages also contain zinc.
According to the statement, the FDA contacted Primus Pharmaceuticals, based in Scottsdale, Arizona, regarding the adverse events, and requested information about the product’s formula, which is now under review by the administration.
“In the interim, the agency is alerting consumers and health care providers about the potential impact to health and advising consumers not to use Limbrel,” the FDA stated. “The FDA is continuing to investigate Primus Pharmaceuticals and the manufacturing process for Limbrel, and will share updates as they become available.”