Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate
FDA Drug Safety Podcast
Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information. This is Lesley Navin, Advanced Practice Nurse.
On February 25, 2019 FDA alerted the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (brand names Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (or RA). FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis.
In this ongoing safety trial, the drug manufacturer, Pfizer, is transitioning patients who were on the 10 mg twice daily dose to the lower, currently approved dose of 5 mg twice daily. The trial is expected to be completed by the end of 2019. We are working with the manufacturer to evaluate other currently available safety information for tofacitinib and will update the public with any new information based on our ongoing review.
Health care professionals should follow the recommendations in the tofacitinib prescribing information for the specific condition they are treating and monitor patients for the signs and symptoms of pulmonary embolism. Advise patients to seek medical attention immediately if they experience any signs or symptoms of pulmonary embolism.
Tofacitinib was approved in 2012 to treat adults with RA who did not respond well to methotrexate. In 2017, we approved tofacitinib to treat patients with psoriatic arthritis, who did not respond well to methotrexate or similar nonbiologic disease-modifying antirheumatic drugs. In 2018, we approved tofacitinib to treat ulcerative colitis.
When FDA first approved tofacitinib, we required a clinical trial with RA patients to evaluate the risk of heart-related events, cancer, and opportunistic infections using 10 mg twice daily or 5 mg twice daily combined with methotrexate in comparison to a tumor necrosis factor (or TNF) inhibitor. An external data safety monitoring committee found an increased occurrence of blood clots in the lungs and death in patients treated with tofacitinib 10 mg twice daily compared to patients treated with tofacitinib 5 mg twice daily or a TNF inhibitor.
Side effects involving tofacitinib should be reported to the FDA MedWatch program at www.fda.gov/medwatch.
A link to the full communication detailing specific information for health care professionals can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at [email protected].
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Related Information
- FDA Drug Safety Communication: Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate
- FDA Drug Safety Podcast: Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate (MP3 - 2.7MB)