FDA alert on Xeljanz safety

Following last week’s news from Pfizer (NYSE: PFE) that it would be transitioning patients on a 10mg dosage of Xeljanz (tofacitinib) to the 5mg strength due to safety concerns stemming from a post-marketing study, the US Food and Drug Administration (FDA) has issued a warning.

An increased risk of blood clots in the lungs, along with a greater danger of death, was found among rheumatoid arthritis (RA) patients taking the stronger dosage of the US pharma major’s drug.

The FDA has stressed in its warning that it has not approved the 10mg twice daily dose for RA, but rather that this strength is only approved in the dosing regimen for patients with ulcerative colitis.