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US FDA Warns of Liver Injury Cases Tied to Amgen's Rare Disease Drug
The agency identified 76 liver injury cases, including seven biopsy-confirmed vanishing bile duct syndrome cases and eight deaths, in postmarketing reports.
- On Tuesday, the FDA identified 76 cases of drug-induced liver injury linked to Amgen's Tavneos, citing "reasonable evidence of a causal association" and urging healthcare providers to discontinue treatment if organ damage is suspected.
- Amgen declined the FDA's request to withdraw the ANCA-associated drug, which the company acquired in a $3.7 billion deal. The manufacturer remains "confident that Tavneos is an important and effective medicine" despite safety scrutiny.
- Postmarketing reviews identified 76 cases of liver injury, with 54 hospitalizations and eight deaths. Seven instances involved VBDS, a rare condition causing permanent organ damage, with three of those patients dying.
- To manage emerging risks, the FDA recommends extensive liver panel testing for patients during the first five months of treatment. Providers should promptly discontinue dosing if liver damage biomarkers or symptoms such as jaundice appear.
- European Medicines Agency officials started a review of Tavneos in January, investigating concerns regarding "data integrity" in the ADVOCATE clinical trial that supported the medication's initial regulatory approvals.
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12 Articles
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 sa…
FDA Warns Of Fatal Liver Risks Linked To Amgen Tavneos Use - Amgen (NASDAQ:AMGN)
The U.S. Food and Drug Administration (FDA) has warned patients and healthcare providers about serious and sometimes fatal liver injuries tied to Amgen Inc.’s (NASDAQ:AMGN) Tavneos (avacopan), citing postmarketing data that point to new safety concerns beyond those identified in clinical trials. Tavneos, approved in October 2021, is used in combination with glucocorticoids and other therapies to treat adults with severe active ANCA-associated va…
FDA Warns of Fatal Liver Injuries Tied to Drug It Wants Pulled From Market
(MedPage Today) -- The FDA on Tuesday warned that postmarketing data has turned up dozens of serious cases of drug-induced liver injury (DILI) associated with avacopan (Tavneos), a vasculitis drug that the agency wants removed from the market...
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