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Currently, the FDA is investigating serious adverse events involving Limbrel (Flavocoxid). While a range of adverse events have been reported, two serious and potentially life-threatening medical conditions are among them: drug-induced liver injury (DILI) 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.
Limbrel (Flavocoxid) is available in capsule form in two dosages: Limbrel 250 and Limbrel 500. The labeling states that the product contains 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. Limbrel (Flavocoxid) manages the production of arachidonic acid metabolites and provides efficacy by inhibiting both COX-1 and COX-2 as well as 5-lipoxygenase (5-LOX), all of which play a role in osteoarthritis. Limbrel (Flavocoxid) is a type of anti-inflammatory, characterized by dual inhibition of the COX enzymes to presumably reduce systemic side effects, as well as 5-LOX to avoid shunting of arachidonic acid metabolism down the pathway involved in gastrointestinal bleeding or ulcers, and renal problems, concerns for both traditional NSAIDs and COX-2 inhibitors.
While the exact evaluation of the observed serious health effects are still ongoing, the FDA is alerting consumers and health care providers about the potential impact to health and advising consumers not to use Limbrel (Flavocoxid). Thus, the recommendations are:
- For Consumers: If you are taking Limbrel (Flavocoxid), 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 (Flavocoxid), 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 (Flavocoxid) 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 (Flavocoxid), the FDA encourages you to work with them to provide clinical information through MedWatch.
Healthcare professionals and patients should report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report