Conditions Resolve After Discontinuing Use

No Deaths Reported by FDA

Update 12/12/17: FDA calls on Limbrel to be voluntarily recalled.

FDA is investigating serious adverse events involving Limbrel, a product in capsule form currently being marketed as a medical food to manage the metabolic processes associated with osteoarthritis. While a range of adverse events have been reported, two serious and potentially life-threatening medical conditions are among them: drug-induced liver injury and hypersensitivity pneumonitis. In total, since 2004, 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. No deaths have been reported by FDA.

A Limbrel representative said, “Our first priority is the health and safety of our patients. As such, we are working closely with the FDA to resolve this food safety concern related to Limbrel for our patients and prescribers. In addition, we are consulting with highly respected independent experts.

“Limbrel is a prescription medical food for the clinical dietary management of the metabolic processes of osteoarthritis to be used under a physician’s supervision. As a medical food, Limbrel must comply with food-safety standards that are rigorous and different than for drugs.”

The company went on to say, “The alert states the FDA has received 194 adverse event reports regarding Limbrel including 57 of the case reports that may have an associative relationship and 30 reports that contain sufficient information to assess a causal relationship. Primus understands these 194 reports have occurred from the time Limbrel was first introduced in 2004 (i.e., nearly 14 years ago).

“FDA specifies two serious medical conditions: hypersensitivity pneumonitis and drug-induced liver injury [elevated liver enzymes]. These are related to individual patient allergic responses. Both conditions have been described in the Limbrel product insert and have been proactively communicated to physicians since 2010. Incidence of each is considered rare or low and generally occurs within the first 1-3 months of use. Importantly, these medical conditions resolve after discontinuing use of Limbrel.

“Limbrel has not been recalled. However, as with all medical decisions, the continued use or discontinuation of the product should be decided by the patient and their doctor.”

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