Drug Safety Alerts

Limbrel MedWatch

11/21/17

On November 21, 2017, the United States Food and Drug Administration (FDA) issued a MedWatch stating they are investigating serious adverse events involving Limbrel capsules, 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.

A complete list of the affected products is provided here:

Limbrel is marketed by Primus Pharmaceuticals Inc., Scottsdale, AZ. Limbrel is available in capsule form in two dosages (250mg and 500mg) and is available with or without zinc. The labeling states that the products contain two types of flavonoids: baicalin (from Scutellaria baicalensis) and catechin (from Acacia catechu).  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.

Health care providers are encouraged to report adverse events or side effects related to the use of these products to the FDA.

CVS/caremark Response: Because of this action, CVS Caremark Mail Service Pharmacy will no longer fill prescriptions for these products.

For more information about this issue, health care providers may call FDA consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov.