FDA Requests Withdrawal of Medical Food Limbrel®

Sarah Randolph
Clinical Account Executive, PharmD, RPh

Primus Pharmaceuticals announced that it will remove Limbrel (flavocoxid) from the market. Limbrel is a medical food that is marketed to “manage the metabolic processes associated with osteoarthritis” and is sold primarily directly from physicians. It is marketed as an alternative to non-steroidal anti-inflammatory drugs (NSAIDs) and opioids. Primus’s removal of Limbrel comes at the request of the Food and Drug Administration (FDA).[1]  The FDA began investigating reports of drug induced liver injury and a lung condition called hypersensitivity pneumonitis related to the use of Limbrel.  There have been 200 reports of these adverse events as of December 4, 2017. Based on their investigations of these reports, the FDA issued an initial public advisory on November 21st, recommending that patients immediately discontinue use of Limbrel and asked Primus to voluntarily recall Limbrel. Primus is actively working to resolve the claim that Limbrel is unsafe for patients and is only removing the drug, “in response to unwarranted pressure from the FDA.”[2]  The FDA continues to investigate the rise in reports of serious adverse events, which may lead to a mandatory recall or a rescission of the current voluntary recall at a later date.

Injured workers who are taking Limbrel and have symptoms such as extreme fatigue, fever, unexplained weight loss, unusual trouble breathing or yellowing of the skin or eyes should seek medical help right away. A report should be sent to FDA’s MedWatch if Limbrel is suspected of causing the problems. More details, including contact information for MedWatch, are in the FDA notice at:

https://www.fda.gov/food/recallsoutbreaksemergencies/safetyalertsadvisories/ucm585992.htm

[1] https://www.fda.gov/food/recallsoutbreaksemergencies/safetyalertsadvisories/ucm585992.htm

[2] http://www.limbrel.com/