The Food and Drug Administration Warns Liver Injuries Possible

The United States Food and Drug Administration (FDA) has announced that it discovered cases of liver injury among patients taking Amgen’s drug for a group of rare autoimmune diseases. The FDA asked healthcare providers to stop using this treatment if there’s a suspicion of organ injury or damage. If you were injured as a result of taking the Amgen drug—Tavneos—you should consult the seasoned Chicago-based lawyers of Moll Law Group. We represent clients around the country, and billions have been recovered in cases with which we’ve were involved.

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In its announcement, the agency stated that it had identified 76 instances of drug-induced liver injury and among those, eight deaths. The evidence suggests that these injuries may be caused by Tavneos. Among the injuries were seven cases of vanishing bile duct syndrome, which is a rare condition that can lead to permanent liver damage.

Tavneos is a medical treatment approved to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, which is a group of rare autoimmune diseases that inflame small- to medium-sized blood vessels.

According to Amgen, the FDA requested that it voluntarily withdraw Tavneos from the market. Concerns had emerged during a re-evaluation of primary endpoint data for nine of 331 patients that were enrolled in a late-stage trial that supported its approval. The company decided not to withdraw the drug because, it said, it wasn’t aware of problems with the underlying patient data, and that it continued to support Tavneos’s benefit-risk profile. It continued to work with the FDA.

The European Medicines Agency has started a review of Tavneos on the grounds that information has emerged that raises questions about its study’s data integrity. In Europe and Australia, the Tavneos labels reference post-marketing cases of vanishing bile duct syndrome, but the United States labels don’t warn about it. Amgen has stated it requested that the FDA add vanishing bile duct syndrome to the Tavneos label, and that this request is still pending.

If you were adversely affected by Tavneos, you may be able to bring a product liability lawsuit. Pharmaceuticals and other products may be defective in terms of their marketing, manufacturing, or design. Most of the time, when the problem is not with the drug but with the marketing, it is considered a failure to warn case; in this case, it might be a failure to warn of vanishing bile duct syndrome. In most lawsuits, it’s necessary to retain an expert to opine on whether there is a defect and whether that defect caused injuries to a plaintiff.

Consult an Experienced Product Liability Attorney

If you or a loved one was harmed by Tavneos, call the knowledgeable Chicago-based product liability lawyers of Moll Law Group to determine whether you have a viable basis to sue for damages. If our firm can establish liability for a defective treatment, we may be able to recover economic and noneconomic damages on your behalf. Complete our online form or call us at 312.462.1700.