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Limbrel® capsules linked to potentially life-threatening health problems

by
Optum Workers' Comp
| Nov 28, 2017

The U.S. Food and Drug Administration (FDA) has issued a warning to consumers and health professionals regarding adverse events, including the potential for two life-threatening health problems associated with Limbrel. Limbrel is a prescription medical food used to manage the metabolic processes associated with osteoarthritis. The potential life-threatening medical conditions include drug-induced liver injury and hypersensitivity pneumonitis, a rare immune system disorder affecting the lungs. The FDA has initiated an investigation based on receipt of 194 adverse event reports and is reviewing the formula of the product provided by its manufacturer, Primus Pharmaceuticals Inc.

Limbrel is available in two dosage forms: Limbrel250 and Limbrel500. Each capsule provides 250 mg or 500 mg of flavocoxid, a proprietary blend of natural ingredients from phytochemical food source materials, as well as 50 mg of citrated zinc bisglycinate, which provides 10 mg of elemental zinc.

The FDA is recommending that patients stop taking Limbrel immediately and contact their health care providers, and for health care providers to encourage their patients to stop taking this product. Patients who are taking Limbrel should contact their doctor or healthcare provider immediately to report any adverse effects and discuss alternative treatment options. We will share updates with regard to this investigation as they become available from the FDA.

For more information on this FDA notice and how to report adverse events, click here.

For more information on osteoarthritis, click here.

Sources

  1. U.S. Food and Drug Administration Safety Alerts for Human Medical Products. Limbrel Capsules by Primus Pharmaceuticals: FDA Advisory - Linked to Potentially Life-Threatening Health Problems. Available at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm586111.htm?utm_campaign=Limbrel%20Capsules%20by%20Primus%20Pharmaceuticals [Accessed 21 Nov. 2017]
  2. Limbrel. Primus Pharmaceuticals Inc. Available at: http://www.limbrel.com/about/limbrel.php. [Accessed 27 Nov. 2017]




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