What is Limbrel?

Limbrel (generic: flavocoxid) is a “medical food” product used to treat osteoarthritis manufactured by Primus Pharmaceuticals. Primus Pharmaceuticals claims the drug works by “restoring the body’s metabolic balance, especially those responsible for inflammation.” Limbrel was approved by the U.S. Food & Drug Administration (FDA) in 2009.

ISSUE

The U.S. Food and Drug Administration is investigating serious adverse events involving Limbrel, a product in capsule form currently being marketed as a medical food to manage the metabolic processes associated with osteoarthritis. While a range of adverse events have been reported, two serious and potentially life-threatening medical conditions are among them: drug-induced liver injury and hypersensitivity pneumonitis. In total, the FDA has received 194 adverse event reports regarding Limbrel, of those, 57 of the cases contained sufficient information to analyze in detail whether Limbrel was associated with an adverse event; 30 of these contained sufficient information to use the Council for International Organizations of Medical Sciences (CIOMS) causality assessment method to determine the likelihood that an association between the consumption of Limbrel and the adverse events reported exists.

BACKGROUND

Limbrel is marketed by Primus Pharmaceuticals Inc., Scottsdale, AZ. Limbrel is available in capsule form in two dosages: Limbrel250 and Limbrel500. The labeling states that the products contain two types of flavonoids: baicalin (from Scutellaria baicalensis) and catechin (from Acacia catechu).  Both dosages also contain zinc.  Claims made on the product label and in labeling indicate that Limbrel is intended to manage the metabolic processes associated with osteoarthritis.

On November 8, 2017, the FDA contacted Primus Pharmaceuticals regarding the adverse events and requested information about the formula for Limbrel. The formula is being reviewed by the FDA. 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 is continuing to investigate Primus Pharmaceuticals and the manufacturing process for Limbrel, and will share updates as they become available.

RECOMMENDATION

For Consumers: If you are taking Limbrel, immediately stop taking it and contact your health care provider.  If you have experienced any of the above-mentioned symptoms or other health problems while taking Limbrel, work with your health care provider to report your symptoms to the FDA through MedWatch.

For Health Professionals: Health care providers who are aware that their patients are taking Limbrel should advise them to immediately stop taking the product. If your patients have experienced any of the above-mentioned symptoms or other health problems while taking Limbrel, the FDA encourages you to work with them to provide clinical information through MedWatch.