Limbrel (flavocoxid) is a medical food product derived from plant sources called flavonoids and flavans that is used to manage osteoarthritis. The U.S. Food & Drug Administration (FDA) requested a Limbrel recall in December 2017, after the product had been linked to cases of drug-induced liver injury and a lung condition called hypersensitivity pneumonitis.
Consumers using Limbrel were urged to stop taking it and contact their doctor.
Limbrel is marketed by Primus Pharmaceuticals and is categorized as a “medical food” by the FDA.
Section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) defines a medical food 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.”
According to the FDA:
Unlike prescription drugs, medical foods do not have to undergo the FDA’s premarket review, registration or approval.
Limbrel was brought to market in 2004. It is currently available in two dosages (250 and 500 mgs), both of which contain a blend of flavonoids: Baicalin (from Scutellaria baicalensis) and catechin (from Acacia catechu). Both dosages also contain zinc.
Limbrel is indicated to manage the metabolic processes associated with osteoarthritis, a type of arthritis caused by wear and tear on a joint, and which is also thought to be associated with metabolic and inflammatory anomalies.
Primus claims that Limbrel:
On November 21, 2017, the FDA warned consumers not to use Limbrel after the product had been tied to 194 adverse event reports, including drug-induced liver injury and a lung condition called hypersensitivity pneumonitis.
“In 30 of those cases, there was sufficient information for FDA medical experts to determine that Limbrel was likely associated with these adverse events,” the agency said. “In recent months, the agency has seen a spike in the number of serious, potentially life- threatening health problems associated with the use of Limbrel to include drug-induced liver injury and hypersensitivity pneumonitis.”
The symptoms of drug-induced liver injury include:
The symptoms of hypersensitivity pneumonitis can vary and may include:
Doctors were advised to contact any patients taking Limbrel and tell them to stop using the product. Limbrel patients who experience any of the above symptoms should contact their healthcare provider immediately.
One December 18, 2017, the FDA sent a letter to Primus Pharmaceuticals formally requesting a Limbrel recall.
“FDA anticipates classifying this recall as a Class I recall, and believes that pursuing this recall request is necessary at this time to address the ongoing public health risk,” the letter stated. “A Class I recall represents a serious health hazard which may be life-threatening. FDA recommends level A (100%) effectiveness checks be performed by your firm to the retail level.”
Primus Pharmaceuticals voluntarily suspended promotion and sale of Limbrel on December 21st. However, the company had not announced a Limbrel recall as of January 2, 2018.
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