FDA Issues a Safety Alert for Limbrel

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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A new safety alert was issued on November 11th for Limbrel, a medical food for patients with osteoarthritis.

What is Limbrel indicated for?

According to the manufacturer, Limbrel is the first prescription product developed and formulated specifically to safely meet the distinctive nutritional requirements of patients with osteoarthritis.  

Limbrel is only available with a prescription, as FDA regulations require that it be used only under a physician’s supervision.  

Why was a safety communication issued for Limbrel?

The FDA issued a safety communication for Limbrel as they received a range of adverse events reported to them.  In early September, the manufacturer began investigating a rise in reports of serious adverse events.

In total, the FDA has received 194 adverse event reports regarding Limbrel including the following 2 serious and potentially life-threatening medical conditions among them:

Has Primus Pharmaceuticals responded to the FDA’s request?

On December 8, 2017, the manufacturer of Limbrel posted a statement on Limbrel safety and FDA review to their website. 

Primus Pharmaceuticals still has not voluntarily recalled Limbrel as they state they are waiting to obtain the documents on which the FDA has based its safety alert and recall request prior to making a final decision.  

Primus Pharmaceuticals feels as though there is conflicting information from the FDA on the adverse effects of Limbrel based on the opinions of independent experts and medical literature in regards to their product; however, they would like to collaborate with the FDA to assure the best solution for both patients and prescribers.  

What should I do if I am currently taking Limbrel?

If you are currently taking Limbrel the FDA recommends you do the following:

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