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….