The US Food and Drug Administration (FDA) is investigating serious adverse events involving flavocoxid (Limbrel, Primus Pharmaceuticals), a prescription product in capsule form that is marketed as a medical food for the management of metabolic processes associated with osteoarthritis.
“While a range of adverse events have been reported, two serious and potentially life-threatening medical conditions are among them: drug-induced liver injury and hypersensitivity pneumonitis,” the FDA said in a safety communication November 21.
The FDA said it has received 194 reports of adverse event involving flavocoxid. In 30 of those cases, there was sufficient information to determine that flavocoxid was likely associated with these adverse events, the FDA said.
Flavocoxid is available in capsule form in two doses: 250 mg and 500 mg. The labeling states that the products contain two types of flavonoids: baicalin (from Scutellaria baicalensis) and catechin (from Acacia catechu). The products also contain zinc. The product labels say flavocoxid is intended for the managaement of the metabolic processes associated with osteoarthritis.
According to the FDA, a medical food is “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”
The FDA has contacted Primus Pharmaceuticals regarding the adverse events and has requested information about the formula for flavocoxid, which is now being reviewed by the FDA.
For now, the agency is asking healthcare providers who are aware that their patients are taking flavocoxid to advise them to immediately stop taking the product.
Any patient who has experienced any symptoms associated with drug-induced liver injury, hypersensitivity pneumonitis, or other health problems while taking flavocoxid should be reported to MedWatch, the FDA’s safety information and adverse event reporting program.
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