FDA Warns Against Use of Limbrel and Requests Voluntary Recall
Dec. 5, 2017
This past week the FDA issued a consumer alert for all consumers taking the product Limbrel to immediately cease taking the drug product due to two serious and potentially life-threatening medical conditions; a drug-induced liver injury and a lung condition called hypersensitivity pneumonitis. The FDA also recommended that Primus Pharmaceutical voluntarily recall Limbrel, which is marketed to "manage the metabolic processes associated with osteoarthritis." The company has not yet recalled the product and Primus executive director, Mary Ann DeMarco, indicated the company has no intention of doing so.
The product has been marketed as a medical food, although a preliminary determination by an FDA investigation is that Limbrel may be an unapproved new drug. Medical foods may be recommended by physicians because certain components may help manage or improve symptoms of a disease or condition. The FDA is investigating a rise in reports of serious adverse events in patients using Limbrel. As of November 21, 2017, the FDA had received 194 adverse event reports regarding Limbrel. In 30 of the reported cases, there was sufficient information for FDA medical experts to determine Limbrel was likely associated with these adverse events.
The product may cause two distinct injuries and anyone who is currently taking Limbrel is at risk. Symptoms of a drug-related liver injury may include nausea, fatigue, jaundice and gastrointestinal discomfort. Symptoms of hypersensitivity pneumonitis are varied and may include headache, fever, chills, chronic bronchitis, shortness of breath or trouble breathing, weight loss and fatigue. Consumers experiencing these symptoms are urged to immediately contact their health care providers.
Limbrel is available in capsule form and comes in two dosages: Limbrel250 and Limbrel500. Primus claims that Limbrel improves mobility in patients with osteoarthritis by "balancing multiple inflammatory pathways to relieve joint discomfort." The FDA requests health care providers to advise patients taking Limbrel to immediately stop taking the product and to work with the FDA to provide clinical information through the MedWatch Safety Information and Adverse Event Reporting Programs.
Questions concerning Limbrel and your legal rights can be directed to Ennis & Ennis, P.A. by calling or visit us online at www.EnnisLaw.com