FDA weighs tighter restrictions for Pfizer's Xeljanz on the heels of safety red flags

The FDA already has restrictions on the use of Pfizer’s JAK inhibitor Xeljanz at a higher dose because of safety concerns. Now, thanks to new red flags, the agency is weighing a move to tighten those restrictions.

In a post Thursday, the FDA alerted patients and doctors that a postmarket study has linked Xeljanz to an increased risk of serious heart-related problems and cancer compared with TNF inhibitors, a group that includes such drugs as AbbVie’s Humira. The problems applied to both the 5-mg twice-daily dose and the higher 10-mg strength.