FDA Requests Voluntary Recall of Limbrel Capsules
December 4, 2017 – The U.S. FDA has recommended a voluntary recall of Limbrel® (flavocoxid) capsules by its manufacturer, Primus Pharmaceuticals. The request is based on concerns regarding an increased number of reports of severe side effects that may be associated with Limbrel’s use.
The U.S. FDA originally issued a public advisory on November 21, 2017, advising consumers not to use Limbrel products due to the risk of liver injury or hypersensitivity pneumonitis, an inflammatory lung disease. The FDA first requested a voluntary recall on November 30, 2017. An FDA investigation has determined that, although Limbrel is marketed as medical food, it is in fact an unapproved new drug.
Limbrel contains two types of flavonoids extracted from plants: baicalin (from Scutellaria baicalensis) and catechin (from Acacia catechu). Certain Limbrel formulations also contain zinc. The product is advertised to help manage osteoarthritis.
Patients taking Limbrel are advised by the FDA to discontinue its use immediately and contact their doctor. If patients using Limbrel experience symptoms including fever, extreme fatigue, yellowing of the skin or eyes, unusual difficulty breathing, or unexplained weight loss, they should seek medical help immediately. A report should be made to the FDA’s MedWatch if Limbrel is suspected as the cause of the symptoms.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.