FDA proposes withdrawing Tavneos after liver-injury warnings
The FDA has proposed withdrawing approval of Tavneos, a drug used with standard treatment for some adults with ANCA-associated vasculitis. The agency says the proposal is not a final removal, and the medicine remains available while the process continues.
The FDA has proposed withdrawing approval of Tavneos, a medicine used with glucocorticoids and other standard treatments for adults with severe active ANCA-associated vasculitis. The agency says this is a proposal, not a final market removal, and Tavneos remains available while the process moves forward.
The FDA’s latest action follows a March 31 safety communication about serious liver injury, including fatal cases and reports of vanishing bile duct syndrome, or VBDS. The agency is asking patients and clinicians to watch for warning signs and to discuss whether the drug should be continued or changed.
What Tavneos is used for
Tavneos, also called avacopan, is approved for adults with severe active ANCA-associated vasculitis, including granulomatosis with polyangiitis and microscopic polyangiitis. It is used along with glucocorticoids and other standard-of-care medicines, not as a replacement for all other treatment.
Why the FDA raised concern
In its March 31 safety communication, the FDA said it had identified postmarketing cases of drug-induced liver injury linked to Tavneos, including fatal cases. The agency said some cases involved VBDS, a serious condition in which bile ducts are progressively damaged or lost, which can lead to lasting liver injury.
In its May 26 proposal, the FDA said new information suggests Tavneos has not been shown to be effective for its approved use and cited the liver-safety concerns as an added reason for moving toward withdrawal.
Symptoms that need attention
The FDA says patients should contact a health care professional right away if they develop possible signs of liver injury, including unusual tiredness, nausea, vomiting, itching, pale stools, yellowing of the skin or eyes, dark urine, swelling in the abdomen, or pain in the upper right side of the belly.
If symptoms are severe, worsening, or accompanied by confusion, fainting, severe abdominal pain, or trouble staying awake, urgent medical care is appropriate.
What clinicians are advised to do
The FDA recommends liver testing before treatment and during therapy, and it advises clinicians to stop Tavneos if liver injury is suspected. The agency also says patients should be counseled about the warning signs and monitored closely for changes in liver function.
Proposal, safety communication, and recall are not the same
A safety communication is the FDA’s way of warning patients and clinicians about a new or changing risk. A recall is a separate action that usually involves removing or correcting a product already in the marketplace. A proposed withdrawal is a regulatory step that can lead to removal if the process is completed, but it is not the same thing as an immediate recall.
What patients and caregivers can do now
People taking Tavneos should not stop treatment on their own. The FDA recommends discussing the safety concerns and alternative treatment options with the prescribing clinician or pharmacist while the regulatory process continues. Caregivers should watch for symptoms of liver injury and help make sure follow-up testing is not missed.
For families and clinicians, the practical takeaway is to treat new jaundice, dark urine, itching, fatigue, or right-upper-abdominal pain as warning signs that deserve prompt medical attention. The FDA says it will continue reviewing the drug’s safety and will provide updates as the process moves ahead.
Sources
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This article is for general informational purposes only and is not medical advice. Research findings can be early or incomplete, and health guidance can change. Always talk with a qualified healthcare professional about personal symptoms, diagnosis, medications, vaccines, screenings, or treatment decisions. If you think you may have a medical emergency, call emergency services right away.
