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

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.

The FDA in January asked Amgen’s ChemoCentryx to voluntarily withdraw avacopan from the market, citing concerns about data from a key trial for the drug and liver damage that is a known risk among users. Amgen told regulators on Jan. 28 it did not intend to withdraw the drug.

“Amgen is not aware of any issues with the underlying patient data and after review of the relevant clinical data and years of real-world evidence, Amgen is confident that Tavneos demonstrates effectiveness and a favorable benefit-risk profile,” the company said at the time.

“Patient safety always comes first, and we are in regular communication with the FDA about the safety of our medicines,” an Amgen spokesperson told The Epoch Times in an email.

While liver injury was recorded in clinical trials of the drug, and cases have been reported following its approval, Amgen remains confident that the benefit-risk profile is favorable, the spokesperson said.

The company says on its website that patients taking Tavneos can continue taking it. The company advises people to speak to the health care provider who prescribed Tavneos before making any changes, such as discontinuing the drug.