FDA Issues a Safety Warning About Limbrel’s Link to Potentially Life-Threatening Health Problems

On December 18, 2017, the U.S. Food and Drug Administration (FDA) sent a letter to Primus Pharmaceuticals, which is the manufacturer of Limbrel, requesting a recall of their products because of the risk of liver injury and a lung condition called hypersensitivity pneumonitis. The FDA recommends that consumers stop using Limbrel immediately and contact their health care provider. The FDA also recommends that health care providers who are aware that their patients are taking Limbrel should recommend that they stop taking it.

Because Limbrel is classified as a medical food, the FDA does not have the regulatory authority to require that the company issue a recall, but it can warn consumers to stop taking it and doctors to stop recommending it to patients.

The FDA issued the warning in November 2017 after receiving a rise in reports of serious adverse events associated with Limbrel. As of December 4, 2017, the FDA had received more than 200 adverse event reports regarding Limbrel. The FDA recommended that Primus Pharmaceuticals issue a voluntary recall but declined to take the product off the market.

What is Limbrel?

Limbrel is a capsule marketed to, “manage the metabolic processes associated with osteoarthritis.” The manufacturer markets Limbrel as a non-medical food product while the FDA maintains that Limbrel is an unapproved drug.

Primus Pharmaceuticals says that Limbrel improves mobility in patients with osteoarthritis by, “balancing multiple inflammatory pathways to relieve joint discomfort.” Recently, on the Limbrel website, Primus announced that it had voluntarily suspended the promotion and sale of Limbrel.

The FDA issued a warning for consumers when they began to receive a high number of adverse event reports from patients who were taking the product. The two most common adverse events are serious and potentially life-threatening events: drug-induced liver injury and hypersensitivity pneumonitis.

What are the symptoms of an adverse reaction to Limbrel?

The FDA lists the symptoms associated with liver injury as:

• Jaundice
• Nausea
• Fatigue
• Gastrointestinal discomfort

The symptoms of hypersensitivity pneumonitis might include:

• Fever
• Chills
• Headache
• Cough
• Chronic bronchitis
• Shortness of breath
• Weight loss
• Fatigue

What should you do if you have been taking Limbrel and think you are experiencing an adverse reaction?

The FDA warns consumers to stop taking Limbrel and contact their doctor. Consumers can report their adverse reactions to the FDA’s MedWatch adverse event reporting program.

The lawyers at Bailey & Greer, PLLC handle dangerous drug and defective medical device cases nationwide. You are welcome to call our medical products liability lawyers toll free at 901-680-9777 or fill out our contact form to schedule an appointment at our Memphis or Jackson office. We have the knowledge, experience, and integrity to help you win your case and recover your losses.