FDA identifies cases of serious liver injury in patients taking Tavneos

The FDA announced it is alerting patients and health care professionals about serious post-marketing cases, including fatal cases, of drug-induced liver injury associated with Tavneos, or avacopan, marketed by Amgen (AMGN). “Some cases involved vanishing bile duct syndrome (VBDS), which is characterized by progressive destruction and disappearance of the bile ducts in the liver. This condition can slow or stop the flow of bile and may lead to permanent liver damage. VBDS is often accompanied by the yellowing of skin or eyes, itchiness, and tiredness. Although hepatotoxicity is a serious adverse reaction for Tavneos identified in premarket clinical trials and described in product labeling, VBDS and DILI cases with fatal outcomes represent new safety concerns. FDA is continuing to monitor postmarketing cases of DILI, including VBDS, involving Tavneos and will provide updates as appropriate,” the FDA stated in its drug safety communication.