FDA Is Reviewing Safety Of Xeljanz 10 mg Twice-Daily Dose Of This JAK Inhibitor, According to February 2019 News Reports
(Posted by Tom Lamb at DrugInjuryWatch.com)
UPDATE: FDA Drug Safety Communication: "Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate" [Posted 02/25/2019]
Pfizer's 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 treatment of adult patients with moderately to severely active rheumatoid or active psoriatic arthritis who have had an inadequate response to certain other drugs.
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]. From that article by John Carroll we get the following information about this still-developing Xeljanz safety story:
In response to a query from Endpoints, a spokesperson for the FDA said they were aware of Pfizer’s move to drop the 10 mg, twice-daily dose of the JAK inhibitor from a required postmarketing safety study — something Pfizer noted in their own statement to us — and would make any recommendations that may come out of that “based on our ongoing review.”
That review was spurred by the news that the trial’s safety monitors had determined the 10 mg dose arm of the Xeljanz study, involving one of Pfizer’s fastest growing products, was linked to a higher death rate as well as “a statistically and clinically important difference in the occurrence of pulmonary embolism” compared to the recommended 5 mg twice daily dose as well as a TNF inhibitor group.
An ongoing FDA safety review of the drug raises serious questions for Pfizer, which markets the 10 mg dose for ulcerative colitis....
Here’s the full statement from the FDA. Judge for yourself.
FDA is aware of Pfizer’s announcement regarding the discontinuation of the [Xeljanz (tofacitinib)] 10 mg group in the ongoing post-marketing required safety study A3921133 in rheumatoid arthritis patients. FDA is working with Pfizer to evaluate currently available safety information for [Xeljanz (tofacitinib)]. Additional recommendations may be made based on our ongoing review. Patients with questions about their treatment should contact their health care provider.
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More information is available in a second February 20, 2019 Endpoints News article written by John Carroll, "Pfizer drops 10 mg dose of best-selling Xeljanz as study spotlights cardio safety issue, higher rate of deaths":
One of Pfizer’s top up-and-coming revenue producers has run into a serious safety issue during a post-marketing study.
According to the company, rheumatoid arthritis patients taking a 10 mg dose of Xeljanz (tofacitinib) in an ongoing safety study are being moved to a 5 mg dose after the independent monitoring board determined that there was an imbalance in the rate of death between the 10 mg drug arm (twice daily) and both their 5 mg arm and a group taking a TNF inhibitor in the control group. The monitors also outlined evidence the 10 mg dose group experienced “a statistically and clinically important difference in the occurrence of pulmonary embolism.”
We give Endpoints News and John Carroll a well-deserved "hat-tip" for breaking this emerging Xeljanz drug-safety story.
Be assured that we will continue to follow their coverage of Xeljanz as well as watch for possible FDA regulatory action concerning the Xeljanz 10 mg twice-daily dose recommended for ulcerative colitis patients.
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