(Nov. 21, 2017) – The U.S. Food & Drug Administration (“FDA”) is investigating serious adverse health events involving the drug Limbrel, a drug that comes in capsule form and is marketed as a “medical food” to manage the metabolic processes associated with osteoarthritis. A “medical food” is more similar to a dietary supplement than a prescription drug — while drugs must undergo stringent tests for safety and effectiveness, dietary supplements and “medical foods” do not. Manufacturers are allowed to sell the products without proving to the Food and Drug Administration (FDA) that the product is safe or effective.
The labeling for Limbrel states that the product contain two types of flavonoids: baicalin (from Scutellaria baicalensis) and catechin (from Acacia catechu), and zinc. Notably, high concentrations of catechins have been linked to liver toxicity.
While a range of adverse events have been reported, the two most serious and potentially life-threatening medical conditions are:
- drug-induced liver injury
- hypersensitivity pneumonitis (an inflammation of the alveoli within the lungs)
On November 8, 2017, the FDA contacted Primus Pharmaceuticals, the maker of Limbrel, and requested information about the formula for manufacturing the drug. That formula is now being reviewed by the FDA. In the interim, the FDA is alerting medical professionals about the potential dangers and advising consumers not to use Limbrel.
If you or a loved one have used Limbrel and experienced Liver Failure or been diagnosed with Hypersensitivity Pneumonitis, contact us online or call 1-866-252-3535 for a free consultation.