FDA Advisory links Limbrel to potentially life-threatening health problems

The US Food and Drug Administration is investigating serious adverse events involving Limbrel (flavocoxid), a product in capsule form currently being marketed as a medical food to manage the metabolic processes associated with osteoarthritis, by Primus Pharmaceuticals.

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.