January 26, 2018: Limbrel, a prescription medical food marketed and sold as a treatment for arthritis, has come under FDA investigation.
Supplements and medical foods are not subject to the same regulation as drugs. Manufacturers can market them without showing proof to the Food and Drug Administration that the products work.
Since it hit the market, approximately 2 million prescriptions for the product have been issued. Thus far, the FDA has received 30 adverse event reports of elevated liver function tests or acute hypersensitivity pneumonitis associated with the use of Limbrel products. These conditions vary in severity and may go unnoticed by the patient until they consult with their physician or until symptoms develop that require hospitalization. Possible symptoms include: abdominal pain, jaundice (yellowing of the skin), intensely itchy skin, fever, chills, malaise, cough, chest tightness, shortness of breath, and/or headache.
The FDA has deemed the adverse side effects of Limbrel as serious and requested that product be recalled. Primus Pharmaceuticals, Inc. of Scottsdale, Arizona disputes that the product causes potentially life-threatening liver toxicity or respiratory failure. However, the company is cooperating with the FDA in the recall and has ceased the promotion and distribution of Limbrel.
The following unexpired products are included in this recall:
- Limbrel (flavocoxid) 250 mg capsules, Product Identity Number 68040-601-16
- Limbrel250 (250 mg flavocoxid with 50 mg citrated zinc bisglycinate) capsules, Product Identity Number 68040-605-16
- Limbrel (flavocoxid) 500 mg capsules, Product Identity Number 68040-602-16
- Limbrel500 (500 mg flavocoxid with 50 mg citrated zinc bisglycinate) capsules, Product Identity Number 68040-606-16
Primus is notifying its distributors by emailed letter and is arranging for the return of all recalled products. Retail pharmacies that have Limbrel products should return them to the wholesale distributor. FDA has recommended that patients who have the Limbrel products that are being recalled should stop use.
If you currently have Limbrel, you should stop using it. If you experience symptoms following using the product, you should contact your healthcare provider.
If you have suffered an adverse reaction, you should report the matter the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report online
- Regular Mail or Fax: Download form or call 1-800- 332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
If you would like to speak to a highly skilled product liability team lawyer please call (877) 230-6690. An attorney and a medical professional evaluate each case and let individuals know what they believe the best course of action to be. All case evaluations and consultations are free and confidential.