FDA latest warning re: Xeljanz

I have been on Xeljanz since mid-2019. I am very fortunate to have it work for me and stop the severe flare I last had. The FDA issued an updated warning on 9/1/2021 and is requiring new and updated warnings about an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with the medicines Xeljanz/Xeljanz XR (tofacitinib), Olumiant (baricitinib), and Rinvoq (upadacitinib) used to treat certain serious inflammatory conditions. I asked my GI about this, and she said it's a tough call, but my benefit at this point is too good to stop, and I do not intend to go off of it. I do have a history of heart disease in the family and was a former smoker. I think one of the differences noted in this latest FDA update is that there is an increased risk of heart-related events even in low or maintenance doses and not just on higher doses. I take 5 mg twice a day. Has anyone heard about this or have any thoughts on this latest news?

Yes, I read about it too. You're right -- the update is adding the existing warning for the 10 mg dosage onto the 5 mg dosage as well. It's the only thing working for me, so I will continue with it.

When I was looking at surgery (before the Xeljanz kicked in) my GI was of the opinion that stelara was unlikely to help (at that stage it had only been licensed for crohns) and I think I've read somewhere it works better for crohns than UC. I already tried infliximab and entyvio, so personally have no interest in rocking the boat with the only drug that has worked for me since I was diagnosed 6 years ago. Most of the data on xeljanz risks comes from RA patients over 50 who have a different set of comorbidities than the average UC patient.

There is now a good del of xeljanz data on non RA available too. See the Imdex talks on Youtube. It is worse for IBD as with most biologicals we need higher doses than rheumatic patients do. But it should not be a surprise that the JAX-STAT inhibitors produce more side effects and therefore great warnings as their actions blocks more cytokines than other mechanisms. There are potentially more powerful but definitely more dangerous drugs as the drug profile comparisons on Bill Sandborns recent Youtube talk list.

Sara, I said rheumatic patients in general and not specific to RA.

My doctor went over xeljanz with me 2 years ago and the black box warning for cancer was a hard no for me. I'll still to my natural regimen even if it takes me longer to get well. No point in replacing one disease with another.

Van: I just saw you posted when I was logged out for a minute. All the biologics have the cancer risk and your post history says you've tried all of them.

VanJordan said...

They all have cancer risk because they are immune suppressing, but none have a black box warning. Those warnings are put when at least 5-10 people die from the drug directly, and it's proven.

I know it's hard to hear that when you've committed to a drug but I'm just telling the truth.

They need to come up with better treatments that don't have these risks.

Have you checked out the colon cancer risk for UC patients? It’s even higher for patients whose IBD is not controlled.

It is one of the many reasons that I chose surgery over continuing these treatments.

The point is these kind of meds (xeljanz, biologics) all have odds of ~1 in several thousand patients experiencing a serious adverse event, i.e. less than 0.1%.

The odds of a serious adverse event on prednisone when taken long term is 100%.

There are no easy solutions with UC.

The odds of a serious event from life are also 100% but it is rather silly to be quoting such. The point is that these drugs will significantly increase certain cancer and infection risks. Yes they are still low odds but if the FDA decide to post a warning on a certain drug then we should take heed and have a discussion with our doctors about the balance of risks. These are scientists giving these warnings poopydoop; the same ones you were defending to the hill in earlier posts on Covid and giving on about pseudoscience.

We should not be giving a blase approach to warnings like this from the FDA to new members of this site or those genuinely looking for advice.

D

damo -- what are you using to treat UC? Any meds or just natural? Not bashing, just asking to get an idea of your experience with these meds

I suspect (thought haven't researched) that most of the biologics have scary warnings. But they all have to be taken with a grain of salt. The FDA is super cautious. The warning about a possible brain disease for Entyvio is based on cases with a different drug that has similarities to Entyvio even though ZERO cases have ever occurred with Entyvio! If we all refuse to take meds that carry warnings many of us would either need surgery or would be dead because diet and natural treatments don't work for everyone.

I don't think anyone is being blase about these meds, but rather are just trying to reassure those who need them that the FDA requiring warnings does not mean that it is a high risk to take them. If it was really a high risk the FDA would stop the distribution of the drug altogether. They have done that with other drugs that had high risks.

Sara14 said...
Lol, yeah.

Yeah, that's what I had read as well. The trial didn't look at UCers. Thanks for posting.

The risk would likely still be there, especially the risk for malignancies., and that's just compared to TNF inhibitors, which themselves already have a higher risk of malignancies compared to placebo.

With that said, I think it may be necessary for many to go on these drugs. I myself am finally about to take the, admittedly scary, step towards biologics as diet and mesalamine has failed to put me in remission.

damo123 said...
. Yes they are still low odds but if the FDA decide to post a warning on a certain drug then we should take heed and have a discussion with our doctors about the balance of risks. These are scientists giving these warnings poopydoop; the same ones you were defending to the hill in earlier posts on Covid and giving on about pseudoscience.

We should not be giving a blase approach to warnings like this from the FDA to new members of this site or those genuinely looking for advice.

D

Who says we haven't discussed with our doctors the balance of risks??
It is a fact that long term prednisone use damages every person who takes it, whether that be through osteoporosis, osteonecrosis, glaucoma or diabetes etc. ks1905 has a hip replacement. I have severe osteoporosis and have to take horrible drugs to prevent a spinal fracture. Sara had a stress fracture in her foot. And that's just 3 people posting on this thread. No one can escape damage from prednisone when taken for years. Whereas most people who take xeljanz or biologics for years will not experience any lasting side effects.
VJ has been on steroids for years yet claims to be healed from a "natural regime" and posts in a way that makes fun of people on biologics and xeljanz.
I'm not trying to downplay the seriousness of these drugs (and I really wish you'd stop making personal attacks because of something you don't like that i posted weeks ago, it just makes you look snarky rather than informed).
I'm trying to put the risks into perspective.

And as CC has said, when you get to the point in your UC where you have been flaring non stop for years, have no quality of life so that you think about suicide anyway, and your doctor says "your options are xeljanz or surgery", then it's a different perspective than if you've been able to manage your symptoms with only 5ASAs (or diet for that matter)

Post Edited (poopydoop) : 9/17/2021 1:30:26 AM (GMT-6)