FDA Warns Consumers About Potentially Life-Threatening Health Problems Linked to Limbrel

SILVER SPRING, Md., Nov. 21, 2017 /PRNewswire/ -- 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. If you are currently using it, stop taking it immediately and contact your health care provider.

The FDA is issuing this warning because of its investigation into a rise in cases of serious adverse events, including drug-induced liver injury and a lung condition called hypersensitivity pneumonitis, involving Limbrel. The agency is also advising health care providers who are aware that their patients are taking Limbrel to tell them to stop using it as well.

The FDA has received a total of 194 adverse event reports regarding Limbrel. In 30 of those cases, there was sufficient information for FDA medical experts to determine that Limbrel was likely associated with these adverse events. In recent months, the agency has seen a spike in the number of serious, potentially life- threatening health problems associated with the use of Limbrel to include drug-induced liver injury and hypersensitivity pneumonitis.

The symptoms of drug-induced liver injury can vary and may include jaundice, nausea, fatigue, and gastrointestinal discomfort. If you experience any of these symptoms, contact your health care provider immediately. The symptoms of hypersensitivity pneumonitis can vary and may include fever, chills, headache, cough, chronic bronchitis, shortness of breath or trouble breathing, weight loss, and fatigue. If you experience any of these symptoms, contact your health care provider immediately.

Limbrel is marketed by Primus Pharmaceuticals Inc., Scottsdale, AZ, and 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

The FDA continues to investigate Primus Pharmaceuticals and the manufacturing process for Limbrel, and will share updates as they become available.  The FDA encourages medical providers to work with their patients to provide clinical information through the MedWatch Safety Information and Adverse Event Reporting Program if they experience any of the above-mentioned symptoms.

Contact: Media: Lyndsay Meyer, 240-402-5345 Consumers: 1-888-SAFEFOOD (toll free)

SOURCE U.S. Food and Drug Administration