FDA ALERT - Limbrel used for Treatment of Joint Stiffness Associated with Potentially Life-Threatening Toxicities
Limbrel (bioflavonoids and zinc glycinate) is a medical food that has an indication for the dietary treatment of swelling, stiffness, and joint discomfort associated with osteoarthritis. The flavonoids used in Limbrel include baicalin and catechin. Limbrel has the benefit of being unassociated with aspirin sensitivity that precludes the use of all nonsteroidal anti-inflammatory agents.
On 11/8/17 the Food and Drug Administration released an advisory announcing an investigation into serious adverse events related to the use of Limbrel. The potential organs involved with the toxicities were the liver with drug-induced liver dysfunction and lung associated with hypersensitivity lung disease. A total of 194 adverse event reports concerning Limbrel were sent to the FDA. Of these reports, 57 were thought to be possibly related, while 30 were definitely associated with the use of the agent.
The FDA has recommended that individuals stop using Limbrel until they have an opportunity to discuss the use of the medical food with their physician. If a decision is made to continue the agent, close monitoring for liver and lung function will be essential.
David Borenstein, MD
Executive Editor TheSpineCommunity.com