The Food and Drug Administration said in a March 31 alert that it has learned of eight deaths linked to a drug called avacopan that is used to treat blood vessel inflammation.
A review of studies, documents from avacopan manufacturer Amgen, and reports to the FDA’s adverse event reporting system resulted in the identification of 76 cases of drug-induced liver injury “with reasonable evidence of a causal association with avacopan use,” the FDA said in a drug safety alert.
Fifty-four of the cases led to hospitalization, and eight ended in death.
Some of the cases involved a syndrome that features the destruction of bile ducts in the liver, which can lead to permanent liver damage.
“Patients should contact their health care professional immediately if they develop any signs or symptoms that may indicate liver injury, such as: feeling more tired than usual; nausea; vomiting; unusual itching; light-colored stools; yellowing of skin or eyes; dark urine; swelling in the stomach or abdomen; or pain in the right upper abdomen,” the FDA stated. “Patients should talk to their health care professional about the safety risks associated with Tavneos and whether to continue therapy or switch to alternative treatments.”
Avacopan, also known as Tavneos, was approved by the FDA in 2021 for the treatment of severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis, or blood vessel inflammation.
Hellbound and Down 