FDA Issues New Safety Alert for Serious Heart-Related Problems and Cancer
Written by: Lauren Schwab, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
A possible Xeljanz recall may be on the horizon following the release of a February 4, 2021, Drug Safety Communication from the U.S. Food and Drug Administration (FDA) regarding new evidence about Xeljanz adverse events. This FDA Xeljanz safety alert was issued following the recent release of findings from a safety clinical trial that shows an increased risk of serious heart-related problems and cancer being associated with Xeljanz.
Summary of Xeljanz History
In 2012 Xeljanz was approved by the FDA to treat adults with rheumatoid arthritis, and in 2017 the drug was approved by the FDA to treat psoriatic arthritis. Shortly thereafter, in 2018, the drug was approved by the FDA to treat ulcerative colitis.
By February 2019 through July 2019, safety clinical trials conducted by Xeljanz manufacturer, Pfizer, began to show an increased risk of blood clots and death when taking the drug at a higher dosage of 10mg twice daily. Patients included in the study were at least 50 years old, and were required to have at least one cardiovascular risk factor.
We reported on the risks of Xeljanz at the higher dosage on our Drug Injury Watch blog in a February 2019 article, "Xeljanz Recommended Dosage For Ulcerative Colitis Patients May Increase Risk Of Pulmonary Embolism":
There appears to be a somewhat "under the radar" drug-safety issue with the 10 mg twice daily recommended dosage of Xeljanz for patients with ulcerative colitis (UC), according to this February 20, 2019 article, "FDA cites an ‘ongoing review’ for Pfizer’s blockbuster Xeljanz, with implications for the class", published by Endpoint News [free subscription required].
Given the results of those 2019 safety clinical trials, the FDA mandated a Black Box Warning label for Xeljanz, in part cautioning doctors about the increased risk of blood clots and death associated with Xeljanz.
According to this February 4, 2021, 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)", while the recent safety clinical trial is complete, the FDA is awaiting additional results:
The clinical trial is now complete and initial results show a higher occurrence of serious heart-related events and cancer in RA patients treated with both doses of tofacitinib compared to patients treated with a TNF inhibitor. FDA is awaiting additional results from the trial.
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Plans for a Xeljanz Recall in the Near Future?
The February 2021 Drug Safety Communication about Xeljanz and its association with heart-related problems as well cancer risks is very concerning because it comes on top of the 2019 Xeljanz Black Box Warning. However, the FDA reportedly will await further information before making any additional Xeljanz label changes or take any other regulatory actions.
According to this February 4, 2021 news report, "No Xeljanz Plan Yet From FDA", it is possible that a Xeljanz recall may be coming in the future, but as of now the FDA is not ready to take action:
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 [i.e., a Xeljanz recall.]
For now, the agency is content with "alerting the public that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer" relative to tumor necrosis factor (TNF) inhibitors.
Since the analysis of the clinical trials is not yet complete, the FDA has reported it will evaluate the results once received and will communicate its final conclusions and recommendations once the review has been completed.
In the same MedPage Today report, "No Xeljanz Plan Yet From FDA", the Black Box Warning is referenced yet again, though there is no mention of when, or even if, a Xeljanz recall will occur:
[Xeljanz (tofacitinib)] and two other JAK inhibitors already carry boxed warnings about increased mortality, thrombosis, and lymphoma and other malignancies. These were mandated after clinical trials showed numerically higher rates of these events with the drug versus placebo or other comparators. The FDA also ordered a dedicated safety study for [Xeljanz (tofacitinib)] to better understand the risks; it did the same for one of the other JAK inhibitors, baricitinib (Olumiant). It did not do so for the third, upadacitinib (Rinvoq).
Under a REMS, drugmakers might be ordered to provide training for prescribers about the risks, develop special educational materials for patients, and/or require patients to certify they received the materials and understand them.
Current Recommendations from the FDA
According to February 2021 Xeljanz Drug Safety Communication issued by the FDA, "Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)", the current recommendations for Xeljanz are as follows:
Patients should not stop taking [Xeljanz (tofacitinib)] without first consulting with your health care professionals, as doing so may worsen your condition. Talk to your health care professionals if you have any questions or concerns.
Health care professionals should consider the benefits and risks of [Xeljanz (tofacitinib)] when deciding whether to prescribe or continue patients on the medicine. Continue to follow the recommendations in the [Xeljanz (tofacitinib)] prescribing information.
Be assured that we will continue to follow this latest Xeljanz drug safety issue as well as watch for possible further FDA regulatory actions, including a possible Xeljanz recall.
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