Amid safety concerns, FDA grants two new JAK approvals — but with added warnings and a key label change

After a post-marketing trial for Pfizer’s Xeljanz turned concerning safety results at the beginning of the year, thwarting the whole JAK class, the FDA is finally rolling out some new approvals — but with added warnings and a key label change.

Both Xeljanz and AbbVie’s Rinvoq got cleared for new indications on Tuesday, but on one condition: They can only be taken after a patient has failed on one or more tumor necrosis factor (TNF) blockers, like Humira or Enbrel.