In late April 2026, Amgen announced a Tavneos vanishing bile duct syndrome warning addition to the Tavneos Prescribing Information document, or drug label, was submitted to the FDA for their consideration. This Amgen action came just two days after the FDA announced it was considering a Tavneos drug recall for reasons having to do with new drug safety concerns and recently discovered irregularities with a key clinical trial related to the approval of Tavneos back in 2021.
For more about this Tavneos vanishing bile duct syndrome warning addition to the Tavneos drug label, we turn to a May 1, 2026, EndpointNews report, “Amgen files update to Tavneos label as FDA escalates push to withdraw“:
[Amgen] filed a supplement on Wednesday that would add more information to the warning label about post-market cases of vanishing bile duct syndrome (VBDS), a serious liver complication that can lead to death. The supplement, disclosed in Amgen’s first-quarter earnings release, marks another twist in the company’s ongoing saga with regulators over Tavneos’ future on the market….The FDA asked Amgen to pull Tavneos from the market voluntarily at the beginning of this year.
[The FDA’s Center for Drug Evaluation and Research (CDER)] reiterated its push in a proposal to withdraw the drug earlier this week, citing new information that it says suggests Tavneos “has not shown to be effective for its approved use,” and that its marketing application held “untrue statements of material fact.” The FDA accused study personnel of manipulating the results of a pivotal clinical trial used to approve the drug. [The FDA’s CDER] also said they were “increasingly concerned” about the drug’s safety.
Here are two recent posts from our DrugInjuryLaw.com website, which are relevant to the Tavneos drug label change that adds vanishing bile duct syndrome (VBDS) warnings: “Tavneos FDA Warnings: Liver Side Effects, Death Cases“; and, “Tavneos Legal Cases: Drug Injury Law Information – Five (5) Points“.
Even before this Tavneos vanishing bile duct syndrome warning addition to the Tavneos drug label was announced by Amgen, we had been looking into the possibility of filing Tavneos liver side effects drug injury lawsuits. Those cases would seek to obtain legal compensation for patients diagnosed with Tavneos-related vanishing bile duct syndrome (VBDS) or Tavneos drug-induced liver injury (DILI).
If you or someone you know was diagnosed with serious Tavneos liver side effects like VBDS or DILI, you can submit a Drug Injury Case Evaluation Form online, email lawyer Tom Lamb at TJL@LambLawOffice.com, or call him at 910-256-2971.
At the Law Offices of Thomas J. Lamb, we represent people in cases where there is a drug injury, sometimes resulting in death, and the legal liability rests with a drug company based on product liability law.
We have many years of experience handling these drug injury and death cases from all parts of the United States. Given our experience, we know that drug injury cases deserve special attention.
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