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Xeljanz Lawsuit Updates
FDA Releases Updated Xeljanz Warning Label to Better Capture Severity of Risk
After new data from a large clinical trial revealed that the arthritis drug Xeljanz increased the risk of serious cardiovascular events, the United States Food and Drug Administration (FDA) required that the drug’s warning label be updated to better reflect the severity of those risks. In December 2021, those new labels went into effect, including new language about the overall mortality risk.
“Based on a completed U.S. Food and Drug Administration (FDA) review of a large randomized safety clinical trial, we have concluded there is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with the arthritis and ulcerative colitis medicines Xeljanz and Xeljanz XR (tofacitinib),” the FDA announced in a Drug Safety Communication in October 2021, noting, “The trial’s final results showed an increased risk of blood clots and death with the lower dose of Xeljanz.”
Xeljanz presently is FDA-approved in 5 mg and 10 mg dosages. The discovery that even the lower dose of Xeljanz resulted in an increased risk was a new discovery, as early results had “reported an increased risk of blood clots and death only seen at the higher dose.”
The new labels released in December 2021 were updated to include this latest information. Xeljanz belongs to a class of arthritis medicines known as Janus kinase (JAK) inhibitors. Two other drugs in this class—Olumiant (baricitinib) and Rinvoq (upadacitinib)—also were required to adopt new and updated warnings.
The December 2021 warnings were just the latest round in a series of increasingly urgent disclosures the FDA has required to accompany Xeljanz. In July 2019, the new Xeljanz warnings included a black box warning, which represents the FDA’s highest level of risk.
As one might expect, the revelation of severe, previously undisclosed risks related to the popular arthritis drug has led patients and their loved ones to resort to the legal system in an effort to attain some form of justice against Xeljanz maker Pfizer.
As of early 2022, Xeljanz lawsuits still had not been centralized as a mass tort action, such as multidistrict litigation (MDL). Instead, a growing number of individual lawsuits are being filed across the US, though there remains the possibility that a Xeljanz MDL or class action might be formed in the future. Lawsuits are being filed on behalf of those who have taken Xeljanz and later were diagnosed with:
• Heart attack
• Ischemic stroke
• Heart failure
• Other major cardiovascular events
If you have been diagnosed with one of the conditions listed above after taking Xeljanz, contact TheLawFirm.com for a free legal consultation!
United States Food and Drug Administration (FDA). (1 October 2021). FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions. FDA Drug Safety Communication
United States Food and Drug Administration (FDA). (25 July 2019). Labeling-Package Insert. Xeljanz. Drugs@FDA: FDA-Approved Drugs