FDA Safety alert for Product Marketed for Osteoarthritis

The US Food and Drug Administration (FDA) has recommended that Limbrel, a capsule marketed to “manage the metabolic processes associated with osteoarthritis.” may be voluntarily recalled by Primus Pharmaceuticals of Scottsdale, Arizona.

The company has not yet acted to remove the product from the market. Although the product is marketed as a medical food, the preliminary determination of the FDA investigation is that Limbrel is an unapproved new drug. The agency does not have mandatory recall authority over drug products.

The FDA reminds consumers not to use any Limbrel products because of the risk of drug-induced liver injury, and a lung condition called hypersensitivity pneumonitis. Consumers taking any Limbrel products should stop immediately and contact their healthcare provider. Health care providers who are aware that their patients are taking Limbrel should advise them to stop using it.

• The FDA continues to investigate a rise in reports of serious adverse events, including drug-induced liver injury and a lung condition called hypersensitivity pneumonitis, involving Limbrel, a product in capsule form currently marketed to “manage the metabolic processes associated with osteoarthritis.”


• On November 30, 2017, the FDA reiterated to Primus Pharmaceuticals the agency’s safety concerns and serious health risks associated with continued use of the product. The FDA recommended a voluntary recall, but so far the company has declined to take the product off the market.


• In early September, the FDA began investigating a rise in reports of serious adverse events, including drug-induced liver injury and a lung condition called hypersensitivity pneumonitis, involving Limbrel, a product in capsule form that has been marketed as a medical food to “manage the metabolic processes associated with osteoarthritis.”


• As of November 21, 2017, the FDA 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 whether Limbrel was likely associated with these adverse events. Since issuing its initial public advisory on November 21, the agency has and continues to receive additional reports, which it is currently evaluating.


• The FDA is advising consumers not to use any Limbrel products because of the risk of drug-induced liver injury and a lung condition called hypersensitivity pneumonitis. If you are taking this product, discontinue it immediately and contact your healthcare provider. Health care providers who are aware that their patients are taking Limbrel should advise them to stop using it.


• Symptoms of drug-induced liver injury can vary and may include jaundice, nausea, fatigue, and gastrointestinal discomfort. If you experience any of these symptoms, contact your healthcare provider immediately.


• Symptoms of hypersensitivity pneumonitis can vary and may include fever, chills, headache, cough, chronic bronchitis, shortness of breath or trouble breathing, weight loss, and fatigue. If you experience any of these symptoms, contact your healthcare provider immediately.