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Posted December 8, 2017

Limbrel Capsules for Osteoarthritis Linked With Potentially Life-Threatening Health Risk, FDA Warns

On December 4, 2017, the FDA urged consumers not to take Limbrel (Primus Pharmaceuticals), a capsule marketed to manage the metabolic processes associated with osteoarthritis, because it has been associated with serious adverse events, including drug-induced liver injury and a lung condition called hypersensitivity pneumonitis. The FDA recommended Primus Pharmaceuticals recall Limbrel, but the company has not recalled the product at this time. 

As of November 21, 2017, the FDA has received 194 adverse event reports about Limbrel. According to the agency's warning to consumers, in 30 of these cases, there was "sufficient information for FDA medical experts to determine whether Limbrel was likely associated with these adverse events." 

Symptoms of drug-induced liver injury may include jaundice, nausea, fatigue, and gastrointestinal discomfort. Symptoms of hypersensitivity pneumonitis fever, chills, headache, cough, chronic bronchitis, shortness of breath or trouble breathing, weight loss, and fatigue.

Limbrel is available by prescription only and is marketed as a medical food to "meet the distinctive nutritional requirements of patients with osteoarthritis." It contains flavocoxid, described on the company's website as a "a proprietary blend of natural ingredients from phytochemical food source materials." The label states that it contains the flavonoids (plant compounds) baicalin (from Scutellaria baicalensis, also known as Chinese skullcap) and catechin (from Acacia catechu). Some capsules also contain zinc.

The FDA warned that anyone who is currently taking Limbrel may be at risk for developing symptoms associated with drug-induced liver injury and/or hypersensitivity pneumonitis and urged that consumers who take this product discontinue it immediately and contact a healthcare provider. 

Primus Pharmacueticals addressed the FDA's warning on its website, stating, in part: "FDA has required that Primus file, under the Freedom of Information Act, requests to obtain their adverse event reports and health hazard evaluation, showing FDA's safety rationale, and Primus has filed these requests but has not yet received FDA's analysis. We cannot, therefore, determine how FDA has reached a different conclusion of Limbrel's safety, or how FDA has concluded that adverse effects that are shown in the published literature to be not life-threatening are in FDA"s view life-threatening. Primus will continue to be transparent and work as closely with the FDA as permitted to resolve any food safety or regulatory concerns related to Limbrel." 

To read the FDA's complete warning, use the link below.