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There is so much else to grab your attention these days it might have been easy to miss the FDA’s recent safety warnings for Pfizer’s JAK inhibitor, Xeljanz, which has been approved for RA patients as well as psoriatic arthritis and ulcerative colitis. These warnings apparently apply to the higher dose of 10 mg/day which, according to the safety trial, showed an increased risk for cardiovascular events and cancer. The safety trial applied specifically to Xeljanz produced by Pfizer. The other main JAK inhibitor on the market is Rinvoq produced by Abbvie, but I haven’t seen any related information for it. I suspect that the Xeljanz situation may raise the scrutiny on Rinvoq. A search already shows class-action lawyers lining up to sign up patients.

A good summary of the situation can be found here: https://www.pmlive.com/pharma_news/fda_considers_new_safety_warnings_for_pfizers_jak_inhibitor_xeljanz_1362988

This is tough news for patients for many reasons.

First of all, of course, are the safety concerns. Taking any kind of advanced treatment such as JAK inhibitors or biologics raises the stakes for increased side effects and safety issues. It especially raises concerns for patients who have been on the medication for a time.

Second, is that it will no doubt impact the use of JAK inhibitors to treat a range of debilitating diseases. This removes a powerful weapon in the fight against RA, PsA and UC.

Third, JAK inhibitors are taken by mouth — they don’t require injection or infusion. This is a much easier treatment option that removes barriers to treatment for those patients who have issues with injected or infused biologics.

The good news is that this kind of safety evaluation does happen and raises appropriate concerns. The bad news is these types of findings tend to make people even more cautious about undertaking other kinds of treatments.

The final determination is not yet in from the FDA. It may be that the lower dose may continue to be used or that the medication might preclude certain classes of patients (e.g., those who are older or have existing conditions).

Update 2/14/2021: A couple of updates, and I’m quoting an article from Medpage Today here. (1) The warnings apply to both the lower and higher doses of Xeljanz. (2) There is no determination yet, awaiting full data analysis, “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.” The FDA has encouraged patients who are on the drug to stay on the drug and/or discuss with their doctor. Here’s the link to the article: https://www.medpagetoday.com/rheumatology/generalrheumatology/91051?xid=nl_mpt_SR_specialty_update_2021-02-14&eun=g1030170d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=SpecialtyUpdate_Rheum_021421_%7BOpt:0060z0000244tvpAAA%7D&utm_term=NL_Spec_Rheumatology_Update_Active_US%20only

I will update further as I see additional news.