FDA Safety Alert for Product Marketed for OA

The US Food and Drug Administration (FDA) has recommended that Primus Pharmaceuticals of Scottsdale, Arizona, voluntarily recall Limbrel, a capsule marketed to “manage the metabolic processes associated with osteoarthritis.”

According to an FDA Advisory issued on November 21, 2017 and updated on December 5, 2017, the FDA is currently investigating serious adverse events involving Limbrel

Background
Marketed by Primus Pharmaceuticals, Limbrel is available in capsule form in two dosages: Limbrel250 and Limbrel500. Both products contain zinc as well as two types of flavonoids: baicalin (from Scutellaria baicalensis) and catechin (from Acacia catechu). Claims made on the product label indicate that the capsules are intended to manage the metabolic processes associated with osteoarthritis.

Issue
The FDA has received 194 adverse event reports regarding Limbrel. Of those, 57 cases contained sufficient information to analyze in detail whether Limbrel was associated with an adverse event and 30 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. While a range of adverse events have been reported in connection to Limbrel, two serious and potentially life-threatening medical conditions are among them: drug-induced liver injury and hypersensitivity pneumonitis.

The FDA contacted Primus Pharmaceuticals on November 8, 2017, requesting information about the formula for Limbrel due to reported adverse events. The FDA is currently reviewing the formula as well as investigating Primus Pharmaceuticals and the manufacturing process for Limbrel.

Recommendation
The FDA has recommended that Primus Pharmaceuticals voluntarily recall Limbrel, though the company has not yet acted to remove the product from the market. Although the product is marketed as a medical food, the preliminary determination of the FDA’s investigation is that Limbrel is an unapproved new drug.

Consumers are advised to immediately stop taking Limbrel and contact their health care providers. Health care providers who are aware that their patients are taking Limbrel should advise them to stop using the product immediately and report any adverse events or side effects to the FDA using MedWatch.

References:

U.S. Food & Drug Administration (FDA). Limbrel Capsules by Primus Pharmaceuticals: FDA Advisory – Linked to Potentially Life-Threatening Health Problems. US Department of Health and Human Services. Published online December 5, 2017.