22 November 2017 - - The US Food and Drug Administration is advising consumers not to use Limbrel, a product in capsule form currently being manufactured as a medical food to manage the metabolic processes associated with osteoarthritis, the agency said.

The FDA is issuing this warning because of its investigation into a rise in cases of serious adverse events, including drug-induced liver injury and a lung condition called hypersensitivity pneumonitis, involving Limbrel.

The agency is also advising health care providers who are aware that their patients are taking Limbrel to tell them to stop using it as well.

The FDA said it has received a total of 194 adverse event reports regarding Limbrel. In 30 of those cases, there was sufficient information for FDA medical experts to determine that Limbrel was likely associated with these adverse events.

In recent months, the agency has seen a spike in the number of serious, potentially life- threatening health problems associated with the use of Limbrel to include drug-induced liver injury and hypersensitivity pneumonitis.

The symptoms of drug-induced liver injury can vary and may include jaundice, nausea, fatigue, and gastrointestinal discomfort.

Limbrel is marketed by Primus Pharmaceuticals Inc., Scottsdale, Arizona, and is available in capsule form in two dosages: Limbrel250 and Limbrel500. The labeling states that the products contain two types of flavonoids: baicalin (from Scutellaria baicalensis) and catechin (from Acacia catechu). Both dosages also contain zinc.

The FDA said it continues to investigate Primus Pharmaceuticals and the manufacturing process for Limbrel, and will share updates as they become available.