FDA Advisory for Limbrel Capsules

Released: 11/30/2017   By: Heidi Dufrene, PharmD

The U.S. Food and Drug Administration (FDA) has issued an advisory for the Primus Pharmaceuticals product, Limbrel, due to potential serious adverse events. Limbrel is a medical food composed of two types of flavonoids, biacalin and catechin. Both dosages also contain zinc. Limbrel is indicated to manage the metabolic processes associated with osteoarthritis. Limbrel is available in 250mg and 500mg capsules.

The two main adverse events that prompted this advisory are drug-induced liver injury and hypersensitivity pneumonitis. Symptoms of liver injury include jaundice, nausea, fatigue, dark urine, and gastrointestinal discomfort. Symptoms of hypersensitivity pneumonitis include fever, chills, headache, cough, weight loss, and shortness of breath. The FDA received 194 adverse event reports, of which 30 had sufficient information to determine a link to Limbel. The FDA has requested information from Primus Pharmaceuticals and is currently reviewing Limbrel’s formula.

At this time, the FDA is recommending that consumers who are taking Limbrel immediately stop and contact their healthcare provider. Anyone who has experienced any of the above symptoms or other health issues while taking Limbrel is asked to work with their healthcare provider to report symptoms to the FDA through MedWatch. Healthcare providers should advise patients who are currently taking Limbrel to discontinue and report any adverse events.

Carlisle Medical will continue to watch for any developments or new advisories concerning Limbrel. Please contact the Carlisle Medical pharmacy if you have any questions at 800-553-1783 or pharmacy@carlislemedical.com.