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The Xeljanz Timeline

2012: The FDA approved Xeljanz for rheumatoid arthritis patients who were not responding to other available medications.

2017: The FDA approved Xeljanz as a treatment for psoriatic arthritis patients.

2018: The FDA approved Xeljanz as a treatment for ulcerative colitis patients.

February 25, 2019: The FDA alerted the public to the Xeljanz safety clinical trial that found an increase in blood clots in the lungs and an increased risk of death in patients taking the 10 mg twice daily dose of Xeljanz.

July 26, 2019: The FDA issued a Black Box Warning for the 10 mg twice daily dose of Xeljanz due to the increased risk of blood clots in the lungs and death. Xeljanz use was limited in treating ulcerative colitis to patients who were not responding to other medications. In the FDA’s safety clinical trial of Xeljanz, they switched patients taking the 10 mg dose to the 5 mg dose.

February 4, 2021: The FDA announced the preliminary results of its Xeljanz safety clinical trial. Patients taking Xeljanz were at an increased risk of heart problems and cancer as compared to patients taking a TNF inhibitor.

September 2021: The FDA announced that it was requiring Pfizer, the manufacturer of Xeljanz, to create an updated warning label that warns patients that they have an increased risk of potentially fatal conditions including heart attacks, stroke, cancer, and blood clots.

November 2021: A new study was published by the Journal of Clinical Radiology and determined that Xeljanz and other drugs in the category of JAK inhibitors carry a risk of blood clots and serious adverse cardiovascular (heart-related) events. The study calls for more research into the inherent dangers posed by Xeljanz and other JAK inhibitors.

December 2021: The FDA reported that Xeljanz’s warning label had been updated to address the FDA’s safety concerns.

FDA’s Recommendations

After the preliminary results of the FDA’s Xeljanz safety clinical trial were announced, the FDA alerted the public and instructed patients to not stop taking Xeljanz without first consulting with their healthcare providers.

How GoldenbergLaw Can Help You

If you or a loved one suffered a heart-related injury or cancer after taking Xeljanz, contact our team at GoldenbergLaw. Our Minneapolis Xeljanz Attorneys have provided our clients the Gold standard of advocacy for over 35 years. Contact us today for a free consultation.


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