Just two days after the FDA announced it was considering a Tavneos drug recall, Amgen countered with a Tavneos label change that adds warnings for vanishing bile duct syndrome (VBDS).
As regards this April 2026 Tavneos label change adding more liver side effects, and specifically the new warning for Tavneos-related vanishing bile duct syndrome (VBDS), we get the following information from a May 1, 2026, EndpointNews report, “Amgen files update to Tavneos label as FDA escalates push to withdraw“:
Amgen has taken steps to update its Tavneos label amid an ongoing battle with the FDA.
The company 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.Regulators also said they were “increasingly concerned” about the drug’s safety.
To understand the context in which Amgen proposed a Tavneos label change that adds vanishing bile duct syndrome warnings by means of its April 29, 2026, filing with the FDA, we point out this excerpt from this April 27, 2026, FDA Drug Alerts and Statements document, “CDER proposes to withdraw approval of TAVNEOS“:
Additionally, CDER is increasingly concerned about the safety profile of TAVNEOS. As further detailed in a March 31, 2026, drug safety communication, CDER has identified cases of serious drug-induced liver injury (DILI) associated with TAVNEOS. Some cases involved vanishing bile duct syndrome (VBDS), which is characterized by progressive destruction and disappearance of the bile ducts in the liver. Although hepatotoxicity is a serious adverse reaction for TAVNEOS identified in premarket clinical trials and described in product labeling, VBDS and DILI cases with fatal outcomes represent new safety concerns.
Here are two recent Drug Injury Watch articles relevant to the Tavneos label change that adds vanishing bile duct syndrome warnings, as well as the possible FDA Tavneos drug recall:
- Tavneos Liver Injury Drug Safety Communication Issued by FDA in Late March 2026 (March 31, 2026)
- Tavneos Lawsuits for Drug Injury After Possible Tavneos Recall (April 17, 2026)
Even before this Tavneos label change that adds more liver side effects in April 2026, we have been investigating possible drug injury lawsuits involving 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 the VBDS or DILI Tavneos liver side effects, 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.
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