The Xeljanz safety issues of Xeljanz causing heart problems and Xeljanz causing cancer were already “highlighted” by means of the Xeljanz Black Box Warning added back in 2019. But in February 2021 the FDA pointed out these Xeljanz side effects again in this FDA Drug Safety Communication, “Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)”.
As to what the FDA did not say in that 2021 Xeljanz FDA Drug Safety Communication — but what seems to be indicated by this latest Xeljanz FDA action — we refer you to this February 4, 2021, MedPage Today news report, “No Xeljanz Plan Yet From FDA”:
But the FDA is not yet prepared to take action, which could include ordering new label language, requiring a risk evaluation and mitigation strategy (REMS), or even pulling the drug from the market.
For the time being, at least, it appears that Pfizer is not inclined to withdraw Xeljanz from the market given that there was a Xeljanz television advertisement that ran in my part of the country during the national nightly news a couple of days after this “new” 2021 FDA drug safety alert about Xeljanz side effects was issued.
One wonders how the FDA might react to this “direct to consumer” advertisement for Xeljanz which Pfizer was still running after the February 2021 FDA Xeljanz Drug Safety Communication about Xeljanz causing heart problems and Xeljanz causing cancer.
It seems within the realm of possibility that the FDA may mandate a Xeljanz recall in the future, but this remains to be seen.
Of course, we will be vigilant as, with the FDA, we wait for “further information” from the safety clinical trial showing an increased risk of serious heart-related problems and cancer associated with Xeljanz.[Read article in full at original source]