Risk of PE with tofacitinib

The US FDA has issued a warning advising of an apparent increased risk of pulmonary embolus during treatment with tofacitinib for rheumatoid arthritis (RA) at a dose of a 10 mg twice daily (the FDA has not approved this dosage regimen  for RA, this dose is only approved in the dosing regimen for patients with ulcerative colitis). During a recent analysis of trial data, an external data safety monitoring committee found an increased occurrence of blood clots in the lungs and death for those treated with tofacitinib 10 mg twice daily compared to patients treated with tofacitinib 5 mg twice daily or who were receiving an alternative treatment with a TNF inhibitor. Read the FDA advisory here