Apparently, the Xeljanz Black Box Warning Added in July 2019 Was Not Enough; Is a Xeljanz Recall Coming Next?
In early February 2021 the FDA doubled-down on these two Xeljanz safety issues: (1) Xeljanz causing heart problems; and (2) Xeljanz causing cancer. 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)", provided the latest details about these "not-new" Xeljanz safety issues. And what I mean by this characterization is there was already a so-called Black Box Warning that points out reports of Xeljanz causing heart problems and Xeljanz causing cancer which was added to the Xeljanz drug label back in July 2019.
As background, Xeljanz (tofacitinib) is approved by the FDA for the treatment of adult patients with moderately to severely active ulcerative colitis (UC). It is also indicated for the treatment of adult patients with moderately to severely active rheumatoid or active psoriatic arthritis who have had an inadequate response to certain other drugs.
During the past two years we have posted these earlier articles about various Xeljanz safety issues:
- February 21, 2019: "Xeljanz Recommended Dosage For Ulcerative Colitis Patients May Increase Risk Of Pulmonary Embolism"
- June 4, 2019: "Xeljanz Related Blood Clots Can Cause Pulmonary Embolism (PE) Or Deep Vein Thrombosis (DVT) With Patient Deaths Possible"
- August 1, 2019: "Xeljanz Warning For Increased Risk Of Blood Clots And Death With Higher Dose Used For Ulcerative Colitis"
- November 4, 2019: "European Medicines Agency (EMA) Warns Xeljanz Increases Risk Of Pulmonary Embolism (PE) And Deep Vein Thrombosis (DVT)"
- March 20, 2020: "Xeljanz Side Effects Include Serious, Potentially Fatal Infections As Well As Blood Clots And Venous Thromboembolism"
Coming back to the present time, let's start by taking a look at what the FDA said at the beginning of its February 2021 Xeljanz Drug Safety Communication:
The U.S. Food and Drug Administration (FDA) is alerting the public that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with the arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib) compared to another type of medicine called tumor necrosis factor (TNF) inhibitors. FDA required the safety trial, which also investigated other potential risks including blood clots in the lungs and death. Those final results are not yet available.
We will evaluate the clinical trial results we have received to date and will work with the drug manufacturer to obtain further information as soon as possible. We will communicate our final conclusions and recommendations when we have completed our review or have more information to share.
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For what the FDA did not say -- but what can be discerned given this latest Xeljanz FDA action -- we turn 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.
It seems highly unusual that the FDA felt compelled to point out, again, in 2021 the Xeljanz safety issues of Xeljanz causing heart problems and Xeljanz causing cancer, as those were already "highlighted" by means of the Xeljanz Black Box Warning added back in 2019.
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 here during the national nightly news just a couple of days ago.
One wonders how the FDA might react to this continued "direct to consumer" advertising for Xeljanz which Pfizer is (still) sponsoring 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.
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