Xeljanz safety trial finds increased blood clot risk in RA patients, FDA says

The FDA, in a safety communication dated yesterday, 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 Pfizer’s Xeljanz was used in patients with rheumatoid arthritis. The FDA has not approved this 10 mg twice daily dose for rheumatoid arthritis; this dose is only approved in the dosing regimen for patients with ulcerative colitis, the agency pointed out. Pfizer on February 19 said it has taken steps to transition rheumatoid arthritis study patients who were on tofacitinib 10 mg twice daily to tofacitinib 5 mg twice daily in the FDA post-marketing requirement study A3921133. “This action is being taken as the result of notification from the tofacitinib Rheumatology Data Safety Monitoring Board (DSMB) of a safety signal regarding the tofacitinib 10 mg twice daily treatment arm. The 5 mg twice daily dose is the FDA approved dose for adult patients with moderate to severe rheumatoid arthritis,” the company said
https://thefly.com/landingPageNews.php?id=2870479