FDA Advises Recall: Limbrel May Be Linked to Drug-Induced Liver Injury

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Healthcare professionals should advise any patients using Limbrel to stop immediately.
Healthcare professionals should advise any patients using Limbrel to stop immediately.

The US Food and Drug Administration (FDA) has released an alert that Limbrel®, a capsule marketed as a medical food to “manage the metabolic processes associated with osteoarthritis,” may be linked to life-threatening drug-induced liver injury and has recommended that Primus Pharmaceuticals (Scottsdale, Arizona) voluntarily recall the product. The company has so far declined to recall Limbrel from the market.

Any healthcare providers who are aware of patients using Limbrel, which the FDA considers an unapproved new drug, should advise them to stop taking it, due to the risk of drug-induced liver injury and hypersensitivity pneumonitis.

In early September, the FDA began investigating Limbrel due to reports of serious adverse events including drug-induced liver injury and hypersensitivity pneumonitis. As of November 21, 2017, the FDA received 194 adverse event reports; in 30 cases, there was enough information to use the Council for International Organizations of Medical Sciences (CIOMS) causality assessment method to determine the likelihood of an association between Limbrel and the adverse events. More adverse event reports have been made since the FDA's announcement on November 21.

The FDA continues to investigate Primus Pharmaceuticals and the formula, product samples, and manufacturing process for Limbrel. More updates will be provided as they become available.

Limbrel is a capsule available in 2 doses: Limbrel250 and Limbrel500. According to the product labeling, the product contains 2 types of flavonoids: baicalin (from Scutellaria baicalensis) and catechin (from Acacia catechu). The product also contains zinc.

The FDA encourages patients and clinicians to report any symptoms through the MedWatch Safety Information and Adverse Event Reporting Program.

Consumers and clinicians who have questions about Limbrel are encouraged to contact the FDA's Division of Drug Information at 888-INFO-FDA (888-463-6332) or druginfo@fda.hhs.gov.

FDA alerts consumers about potentially life-threatening health problems linked to Limbrel [press release]. FDA newsroom. https://www.fda.gov/Food/RecallsOutbreaksEmergencies/SafetyAlertsAdvisories/ucm585992.htm. Published December 4, 2017. Accessed December 6, 2017.

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