Background Limbrel (flavocoxid) is an anti-inflammatory agent comprised mostly of flavonoids such as baicalin and catechin that is prescribed to manage the metabolic processes associated with osteoarthritis. This supplement has traditionally been classified and marketed as a "medical food," which is defined by the Orphan Drug Act as: "a food … [Read more...]
Primus Pharmaceuticals Refuses To Recall Limbrel Despite FDA Request
On November 21, 2017 the FDA issued this Safety Alert for Human Medical Products: “Limbrel Capsules by Primus Pharmaceuticals: FDA Advisory – Linked to Potentially Life-Threatening Health Problems”. More recently, there was a December 4, 2017 FDA statement which can be found on this Safety Alerts & Advisories page, “FDA Alerts Consumers … [Read more...]
Osteoarthritis “Medical Food” Limbrel Tied to Life-Threatening Events
What is Limbrel? Limbrel is marketed by Primus Pharmaceuticals Inc., and is classified as a "medical food," which the FDA defines as: A food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive … [Read more...]