FDA Warns of Deaths Linked to Drug It Wants Removed From Market

Patients taking avacopan should immediately contact a health care professional if they develop symptoms indicating liver injury, regulators said.
FDA Warns of Deaths Linked to Drug It Wants Removed From Market
An Amgen sign outside the company's headquarters in Thousand Oaks, Calif., on May 17, 2023. Mario Tama/Getty Images
Zachary Stieber
Zachary Stieber
Senior Reporter
|Updated:
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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.