In July 2019, the U.S. Food and Drug Administration approved a black-box warning for the Xeljanz (tofacitinib) drug label due to a higher risk of blood clots and death. The changes followed a review of data from a clinical trial on the safety of Xeljanz and Xeljanz XR in patients with rheumatoid arthritis taking a higher daily dose of the drug.
Xeljanz is approved for treatment of several conditions, including rheumatoid arthritis and ulcerative colitis. The drug was initially approved for rheumatoid arthritis in 2012 at doses of 5 mg twice per day. The drug’s use was expanded to psoriatic arthritis in 2017 and to ulcerative colitis in 2018. Patients taking Xeljanz for ulcerative colitis can have doses of 10 mg twice per day. However, in those taking Xeljanz, blood clots began to be reported with alarming frequency, leading the FDA to investigate.
The FDA has been conducting post-market studies of the drug to monitor its safety and efficacy. In an ongoing trial examining patients with rheumatoid arthritis taking the higher dose of Xeljanz, blood clots were found at much higher rates. The risk of dying was also much higher compared to patients who took a lower dose or a different medication.
Dozens of Xeljanz deaths have been reported involving patients 50 or older who had rheumatoid arthritis and at least one cardiovascular risk factor. Xeljanz deaths were more common in those taking the 10 mg dosage twice per day.
In response to these findings, the FDA ordered a black-box warning, which is the strongest type of warning for a drug, to appear on the drug label concerning doses of 10 mg twice a day. The warning advises patients of the link between Xeljanz and blood clots, especially at higher dosages. The FDA further ordered that the warning state that patients with ulcerative colitis should only take Xeljanz if they have not responded to treatment with other medications or have experienced unmanageable side effects due to those medications.
The FDA advised patients taking Xeljanz or patients who might be candidates for Xeljanz to talk to their doctors about any past issues with blood clots or heart problems and to immediately seek medical treatment if they have symptoms of a blood clot.
If you or someone you love has taken Xeljanz and blood clots developed that caused injury or death, contact Parker Waichman LLP for a free consultation. An experienced attorney at our firm can help answer your questions about your personal injury case and determine if you should pursue a legal claim for compensation.
