Limbrel

Manufactured by Primus Pharmaceuticals, Inc., Limbrel is a prescription food supplement designed to provide nutrition to patients with osteoarthritis, especially elderly patients who cannot use NSAIDs and have a strong desire to avoid opioid use if possible.

On December 18, 2017, the U.S. Food and Drug Administration (FDA) sent a letter to Primus Pharmaceuticals accusing Limbrel of having false and misleading labels. According to the FDA, Limbrel does not meet the definition of a medical food and has led to many cases of drug-induced liver injury, pancreatitis, and hypersensitivity pneumonitis.

After the FDA issued a public advisory on November 21, 2017, Primus announced a voluntary product recall of Limbrel on January 26. 2018.

The Symptoms

• Symptoms of drug-induced liver injury can vary and may include jaundice, nausea, fatigue, and gastrointestinal discomfort.
• Symptoms of pancreatitis can vary and may include abdominal pain, fever, rapid pulse, nausea, vomiting, and weight loss.
• 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 health care provider immediately.

FDA Advisory

The FDA warns 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, contact your health care provider. The FDA also warned health care providers to advise their patients to stop taking Limbrel immediately. The FDA is currently investigating a rise in reports of serious adverse events, including drug-induced liver injury and the lung condition called hypersensitivity pneumonitis, involving Limbrel.

If you or anyone you know has been adversely affected by Limbrel, contact an attorney from the Arentz Law Group, P.C. by calling 1-800-305-6000 to schedule your free initial consultation.