Limbrel Withdrawn from Market
January 4, 2018 – Primus Pharmaceuticals has withdrawn its Limbrel® (flavocoxid) products from the market in response to requests from the U.S. FDA. In November and December of 2017, the FDA raised concerns about the safety of Limbrel products, which were dispensed primarily through doctor’s offices and labeled as providing “clinical dietary management of the metabolic processes of osteoarthritis.” Although all forms of Limbrel were distributed as a medical food, the FDA stated that it believed the products to be unapproved new drugs, with the potential for causing liver damage and a respiratory condition known as hypersensitivity pneumonitis.
The FDA has received at least 200 reports of adverse events believed to be tied to Limbrel. Primus has vigorously defended its product, releasing a statement on the Limbrel website that “the rare adverse events at issue for Limbrel are of much less concern than the known adverse effects for alternative osteoarthritis (OA) treatments, NSAIDs and opioids.” Primus holds that its product, which is derived from plants, is “an important and in many cases the only medical option for people suffering from osteoarthritis.”
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.