Osteoarthritis drug Limbrel has been linked to serious side effects including drug-induced liver damage and hypersensitivity pneumonitis. On December 5, 2017, the FDA issued a Drug Safety Alert urging the manufacturers of Limbrel to recall it after an investigation determined it to be an “unapproved new drug.”
Consumer Safety Watch is currently investigating injuries on behalf of individuals who have suffered from serious injuries linked to the supplement/drug Limbrel.
The Food and Drug Administration (FDA) has encouraged anyone taking Limbrel to immediately stop and contact their health care provider. It has also been requested that the manufacturer of Limbrel issue an immediate recall of the product.
Patients taking Limbrel should be aware of the side effects associated with drug-induced liver disease, which can include:
Drug-Induced Liver Injuries
Patients who experience any of the following side effects may be suffering from hypersensitivity pneumonitis and should contact their health care provider as soon as possible.
What is Limbrel?
Limbrel (generic: flavocoxid) is a “medical food” product used to treat osteoarthritis manufactured by Primus Pharmaceuticals. Primus Pharmaceuticals claims the drug works by “restoring the body’s metabolic balance, especially those responsible for inflammation.” Limbrel was approved by the U.S. Food & Drug Administration (FDA) in 2009.
The U.S. Food and Drug Administration is investigating serious adverse events involving Limbrel, a product in capsule form currently being marketed as a medical food to manage the metabolic processes associated with osteoarthritis. While a range of adverse events have been reported, two serious and potentially life-threatening medical conditions are among them: drug-induced liver injury and hypersensitivity pneumonitis. In total, the FDA has received 194 adverse event reports regarding Limbrel, of those, 57 of the cases contained sufficient information to analyze in detail whether Limbrel was associated with an adverse event; 30 of these contained sufficient information to use the Council for International Organizations of Medical Sciences (CIOMS) causality assessment method to determine the likelihood that an association between the consumption of Limbrel and the adverse events reported exists.
Limbrel is marketed by Primus Pharmaceuticals Inc., Scottsdale, AZ. Limbrel 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. Claims made on the product label and in labeling indicate that Limbrel is intended to manage the metabolic processes associated with osteoarthritis.
On November 8, 2017, the FDA contacted Primus Pharmaceuticals regarding the adverse events and requested information about the formula for Limbrel. The formula is being reviewed by the FDA. In the interim, the agency is alerting consumers and health care providers about the potential impact to health and advising consumers not to use Limbrel.
The FDA is continuing to investigate Primus Pharmaceuticals and the manufacturing process for Limbrel, and will share updates as they become available.
For Consumers: If you are taking Limbrel, immediately stop taking it and contact your health care provider. If you have experienced any of the above-mentioned symptoms or other health problems while taking Limbrel, work with your health care provider to report your symptoms to the FDA through MedWatch.
For Health Professionals: Health care providers who are aware that their patients are taking Limbrel should advise them to immediately stop taking the product. If your patients have experienced any of the above-mentioned symptoms or other health problems while taking Limbrel, the FDA encourages you to work with them to provide clinical information through MedWatch.
Did you or a loved one suffer side effects such as drug-induced liver damage or hypersensitivity pneumonitis following use of the unapproved drug Limbrel?
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