Osteoarthritis: FDA urges patients to discontinue flavocoxid use immediately
Takeaway
- The Food and Drug Administration (FDA) has recommended patients receiving flavocoxid (Limbrel) discontinue use immediately because of the potential for liver injury and lung disease.
Why this matters
- Flavocoxid capsules are marketed to patients with osteoarthritis to “manage the metabolic processes associated with osteoarthritis.”
- Because of the risk for serious adverse events, the FDA recommends clinicians contact patients receiving the drug immediately to tell them to stop taking flavocoxid.
- Patients experiencing symptoms of an adverse event are encouraged to report them via the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Key points
- The FDA had received 194 reports of adverse events as of November 21, 2017, 30 of which the FDA was able to determine were related to flavocoxid.
- Liver damage and hypersensitivity pneumonitis are the 2 adverse effects associated with the drug.
- The FDA issued the recommendation on November 30, 2017, but Primus Pharmaceuticals has not taken action to recall the product.
- Flavocoxid contains flavonoids baicalin (from Scutellaria baicalensis) and catechin (from Acacia catechu), and both dosages contain zinc.
- Additional questions can be directed to the FDA Division of Drug Information: 888-INFO-FDA (888-463-6332) or druginfo@fda.hhs.gov.
