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 nutritional requirements, based on recognized scientific principles, are established by medical evaluation.
More specifically, Limbrel is a flavonoid capsule that contains baicalin, catechin, and zinc, and comes in two different dosages. It is intended to manage the nutritional requirements and metabolic processes of osteoarthritis patients.
On November 21, the FDA announced that it is currently investigating the association between Limbrel and two potentially life-threatening conditions: drug-induced liver injury and hypersensitivity pneumonitis. The safety alert from the FDA provides the following information:
In total, the FDA has received 194 adverse event reports regarding Limbrel, of those, 57 of the cases contained sufficient information to analyze in detail whether Limbrel was associated with an adverse event; 30 of these 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.
Primus Pharmaceuticals has provided information to the FDA regarding the formula and manufacturing process for Limbrel, which are currently being reviewed.
In the meantime, the FDA encouraged those taking Limbrel to stop immediately and contact their doctor. In addition, they recommend reporting any adverse side effects from Limbrel through the FDA MedWatch reporting system.
It will be interesting to see whether the package insert and FDA warnings for Limbrel are altered to include drug-induced liver injury and hypersensitivity pneumonitis.
We will continue to monitor the medical literature concerning Limbrel’s association with these side effects, report on the FDA’s findings from its research on Limbrel’s formula and its manufacturing process.
Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
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