Safety Alert on Pfizer’s Xeljanz

A new FDA safety alert warns patients and healthcare professionals about Pfizer’s tofacitinib (Xeljanz, Xeljanz XR) after a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of the drug was used in patients with rheumatoid arthritis. “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,” the alert says.

The safety study was a required post-approval study, the alert says, and rheumatoid arthritis patients in the trial were required to be at least 50 years old and have at least one cardiovascular risk factor. “During the most recent analysis of the trial, 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,” it says.