Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
Limbrel (flavocoxid) is an anti-inflammatory agent comprised mostly of flavonoids such as baicalin and catechin that is prescribed to manage the metabolic processes associated with osteoarthritis.
This supplement has traditionally been classified and marketed as a "medical food," which is defined by the Orphan Drug Act 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."
Recently, Limbrel has been under fire by the FDA due to its alleged misclassification as a "medical food," as well as the increasing number of adverse side effects that have been reported by users of Limbrel.
Limbrel Side Effects
While a range of reactions have been reported to the FDA by users of Limbrel, the most serious and potentially life-threatening ones are as follows:
- Drug-induced liver injury
- Hypersensitivity pneumonitis (inflammation of the alveoli within the lung)
While drug-induced liver injury and hypersensitivity pneumonitis (HP) were previously mentioned on the FDA's website page about Limbrel, the pancreatitis side effect was more recently discussed in the FDA Requested Recall letter, mentioned in the following section of this article.
HP in particular can be difficult to diagnose, given that the symptoms -- such as fever, chills, fatigue, cough, chest tightness, difficulty breathing, and headache -- are common to other, less serious conditions. Clinical, radiological, physiological, and immunological tests are often needed in order to properly diagnose this condition.
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Of note, the package insert for Limbrel (accessed 1/12/18) does warn that there have been "rare" cases of HP observed in those taking Limbrel, but brushes the warning aside saying that those who experienced this side effect eventually "recovered uneventfully and without residua."
They also warn of "rare cases of severe hepatic reactions accompanied by jaundice or eosinophilia," in a casual manner, stating that "all of these cases resolved within 2-4 weeks without residua after LIMBREL was discontinued."
To clarify, the manufacturers probably used the word "residua" in these warnings to mean "residual effects." Going forward, they had better hope that their legal teams pay more attention to semantics when defending their classification of Limbrel as a "medical food" against the FDA.
Trouble with the FDA
The FDA disagrees with Limbrel's classification as a medical food, and has argued that it is actually a "new drug" that has not been approved by the FDA "on the basis of scientific data and information demonstrating that the drug is safe and effective." As such, the FDA urged consumers to immediately stop taking Limbrel, and the manufacturer, Primus Pharmaceuticals, to voluntarily recall it.
In November 2017, the FDA initially contacted Primus in regard to the numerous reports of potentially life-threatening side effects of Limbrel observed by consumers and medical professionals. Several weeks later, they reiterated their concerns related to these possible side effects and recommended a voluntary recall.
Primus initially refused to comply, prompting a "Requested Recall" letter from the FDA in mid-December 2017, which stated:
This letter is to request that you cease distribution and immediately initiate a recall of all lots within expiry of the following products:
- Limbrel (flavocoxid) 250 mg capsules
- Limbrel250 (250 mg flavocoxid with 50 mg citrated zinc bisglycinate) capsules
- Limbrel (flavocoxid) 500 mg capsules
- Limbrel500 (500 mg flavocoxid with 50 mg citrated zinc bisglycinate) capsules
As of earlier this month, Primus has finally agreed to comply with the FDA's request to cease the promotion and sale of Limbrel.
They have criticized the FDA at every step, however, claiming that they have received "unwarranted pressure" from the FDA, who has issued "repeated aggressive press releases" urging them to withdraw Limbrel from the market in spite of "the major public health implications."
We will monitor the medical and legal news for updates on this situation, and report any significant developments as we become aware of them.
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