FDA: Potentially Life-Threatening Adverse Events Linked to Limbrel

Advise patients to immediately stop taking the product
Advise patients to immediately stop taking the product

The Food and Drug Administration (FDA) has issued an advisory regarding serious adverse events linked to the medical food Limbrel (flavocoxid; Primus).

Limbrel is indicated for the dietary management of the metabolic processes associated with osteoarthritis, and is available in 250mg and 500mg strength capsules. The capsules contain two types of flavonoids called bicalin (from Scutellaria baicalensis) and catechin (from Acacia catechu); both dosages contain zinc. 

A total of 194 adverse events have been reported regarding Limbrel, and an association between its use and the reported adverse events was determined in 30 of those cases. 

Specifically, there have been reports of two serious and potentially life-threatening medical conditions among these adverse events: drug-induced livery injury and hypersensitivity pneumonitis. Symptoms of drug-induced liver injury can include jaundice, nausea, fatigue, and gastrointestinal discomfort. Symptoms of hypersensitivity pneumonitis can include fever, chills, headache, cough, chronic bronchitis, shortness of breath or trouble breathing, weight loss, and fatigue.

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While the FDA is reviewing the formula and manufacturing process for Limbrel, clinicians and consumers are recommended not to use the product. Consumers should immediately discontinue use and report any of the aforementioned symptoms if they occur. Healthcare professionals should advise their patients to immediately stop taking Limbrel and report any symptoms related to the product to MedWatch.

For more information call (480) 483-1410 or visit FDA.gov.