The Food and Drug Administration (FDA) recently released an advisory statement warning that there could be severe adverse events resulting from the use of a medical food product called Limbrel. It is used to provide important nutrient for patients with osteoarthritis, but adverse event reports from the FDA have been numerous and point to life-threatening possibilities. There is no recall yet, but the product is under investigation.

What is Limbrel?

Limbrel is a product known as a medical food. A medical food as defined by the FDA is any food that is intended to be used for managing a disease through dietary means and that is used with the supervision of a doctor. For example, a nutritional supplement for someone with a serious deficiency would be considered a medical food. These products require a prescription, just like with medications. Also, like medications, they must be approved by the FDA.

Limbrel is a medical food for patients with osteoarthritis. The company that makes Limbrel, Primus Pharmaceuticals, claims that the flavonoid combinations in the product meet the nutritional requirements of people living with osteoarthritis. The company states that these nutritional needs cannot be met through other dietary changes. Limbrel comes in two doses: 250 or 500 mg.

Limbrel and Adverse Events

The FDA’s adverse event reporting system has recorded numerous instances of events in patients using Limbrel. The focus of the current warning about the medical food is two potentially life-threatening adverse events. These are hypersensitivity pneumonitis and drug-induced liver injury.

Hypersensitivity pneumonitis is an immune system condition that is rare. It causes inflammation in the lungs and can be very serious. There can be permanent damage to the lungs. Signs of this condition include shortness of breath, coughing, fever, chronic bronchitis, chills, fatigue, and weight loss. Limbrel may also cause liver injury, which can also be serious and life-threatening. Signs of drug-induced liver injury include fatigue, nausea, jaundice, and gastrointestinal upset.

The FDA’s Warning and Recommendations

The FDA has determined that there is enough information from the adverse events reports to conclude that Limbrel was likely a trigger or contributing cause for the noted cases of liver injury and hypersensitivity pneumonitis. The FDA is recommending that anyone taking Limbrel stop taking it immediately and contact their physicians. The FDA also recommends that patients using Limbrel know the signs of the two potential conditions and report them to a doctor immediately.

In the meantime, the FDA is working with Primus Pharmaceuticals. The FDA will get the formulation for Limbrel and will analyze it. Until the agency has determined what the issue is and gathered more information, it strongly recommends that no one use Limbrel. Doctors are being told to advise patients of this warning and to stop using Limbrel. They are also encouraged to contact the FDA to provide more information for the investigation.

The conditions that Limbrel is now associated with are very serious, and although not common can be life-threatening. The benefits of using Limbrel are considered at this point to not be worth the risks of the side effects. This means that no one should be using the product until the investigation has been concluded. At that time the product will either be determined to be safe or found to be too risky to be used.