The US Food and Drug Administration has circulated new warnings about an increased threat of thrombosis and death among ulcerative colitis patients taking the 10 mg twice each day dose of the drug tofacitinib (Xeljanz, Xeljanz XR).
The company also mentioned that the authorized use of tofacitinib for ulcerative colitis would be restricted to sure patients who don’t respond to, or who have severe side effects with, certain other medicines.
The changes, including adding the FDA’s most prominent Boxed Warning, have been made after the agency reviewed interim data from an ongoing scientific trial assessing the protection of 5 mg and 10 mg twice daily doses of tofacitinib in patients with rheumatoid arthritis. That data showed an elevated danger of blood clots and loss of life in patients treated with the 10 mg twice daily dose, in contrast with tofacitinib 5 mg twice daily or a tumor necrosis issue blocker, based on the FDA. The agency first authorized tofacitinib in 2012 to deal with adult patients with rheumatoid arthritis who didn’t reply nicely to methotrexate. The approved dose for those patients is 5 mg twice a day. In 2018, the FDA permitted the drug to deal with ulcerative colitis.
The FDA mentioned health care professionals ought to counsel patients to cease taking tofacitinib and search quick emergency medical attention if they develop any unusual signs, including those that might signal a blood clot. Health care suppliers ought to avoid prescribing tofacitinib for patients who could have a greater danger of thrombosis and use tofacitinib on the lowest effective dose or limit the period of the 10 mg twice daily dosage when treating ulcerative colitis.