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FDA Issues Another Alert as Xeljanz Investigation Continues

By Burg Simpson
February 4, 2021
2 min read

On February 4, 2021, the FDA alerted the public about an increased risk of major health problems associated with Xeljanz (tofacitinib). According to the FDA’s statement, a clinical trial evaluating the safety Xeljanz found an increased risk of serious heart-related problems and cancer compared to another type of arthritis medication.

Xeljanz is a medication approved to treat Rheumatoid Arthritis (RA), psoriatic arthritis (PsA), and ulcerative colitis. An overactive immune system contributes to RA, PsA, and ulcerative colitis, and Xeljanz is designed to decrease the activity of the immune system. The FDA required Pfizer, the manufacturer of Xeljanz, to conduct a clinical trial to evaluate the medication’s safety.

Reporting on these clinical trial results first came out in 2019, when scientists discovered an increased risk of blood clot in the lungs and death associated with a higher dosage of Xeljanz. Burg Simpson previously wrote about those findings here. In response to the initial results, the FDA required Pfizer include a boxed warning of the increased risk of blood clots and death linked to the higher dosage.

Today’s FDA alert marks the second set of alarming results from the study. As reported, results show a higher occurrence of serious heart-related events and cancer in Xeljanz users compared to patients treated with another type of arthritis medicine called a TNF inhibitor. The FDA continues to review the results of the clinical trial. In the meantime, Burg Simpson is investigating potential product liability lawsuits regarding Xeljanz.

If you or a loved one have been diagnosed with cancer, suffered a major cardiovascular event, or died while taking Xeljanz, contact one of the experienced dangerous drug attorneys at Burg Simpson today to discuss your legal rights. Our award-winning lawyers possess the knowledge and resources to investigate your potential claim and fight dangerous drug manufacturers that refuse to take responsibility for the harm they cause. Call us at 513-852-5600 or fill out our contact form for a FREE no-obligation consultation today.


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