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Limbrel

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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 a “Medical Food”

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:

• Medical foods are specifically formulated and processed. As such, they do not exist in a natural food state.
• Medical foods must be labeled for the dietary management of a specific disease, disorder or condition, for which there are distinctive nutritional requirements.
• Medical foods are intended to be used under medical supervision, and are only indicated for patients who are under active and ongoing medical supervision.

Unlike prescription drugs, medical foods do not have to undergo the FDA’s premarket review, registration or approval.

How Does Limbrel Work?

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:

• Has both anti-inflammatory and antioxidant properties in a concentrated form which cannot be obtained through normal diet.
• Restores the body’s normal metabolic inflammatory processes through dual inhibition of excess arachidonic acid metabolization and antioxidant action.
• Manages production of arachidonic acid metabolites, while inhibiting COX-1, COX-2, and 5-LOX (5-lipoxygenase), all of which contribute to osteoarthritis.

FDA Limbrel Warning

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:

• Jaundice (yellowing of the skin or eyes)
• Nausea
• Fatigue
• Gastrointestinal discomfort

The symptoms of hypersensitivity pneumonitis can vary and may include:

• Fever
• Chills
• Headache
• Cough
• Chronic bronchitis
• Shortness of breath or trouble breathing
• Weight loss
• Fatigue

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.

FDA Seeks Class I Limbrel Recall

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 21^st. However, the company had not announced a Limbrel recall as of January 2, 2018.