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)

 

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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]

(2/25/19)

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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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