Lialda making symptoms worse?

[KatyBuckeye]

I've been taking Lialda 2.4mg twice daily for about 3 weeks now, since my diagnosis with Crohn's. Initially, I had the impression that it was making my symptoms much worse. I went from having 1 looser (soft serve) BM once a day to 6-10 watery, straight diarrhea BMs. The GI doc told me to call the office if I did experience an increase in symptoms, as Lialda can cause this in a small percentage of patients. When I did call the office, however, I was told that it wasn't the medication, but probably because of my high stress level. I thought that it could have been possible, as I was VERY upset and stressed about the Crohn's diagnosis and all of the wonderful things the doctors tell you to look forward to. Anyway, the GI doc wanted me to stay on the med. The diarrhea eventually began to decrease as I started following the SCD diet. At one point, I even had ONE blessed day of an almost normal BM (formed, but in ribbons). And then the diarrhea returned. I do feel that the SCD diet is helping quite a bit because I can definitely tell when I accidently eat something that is not allowed or I'm not ready for yet. Diarrhea, gas, and bloating return full-force. If I follow the diet exactly, I have 2-3 loose BMs daily.

The last few days, I've missed some doses of the Lialda (2.4mg, instead of the 4.8 total that I'm supposed to be on). And I'm finding that I'm feeling much better overall. The stool is becoming more formed again and I'm only having 1 BM daily. I've had a "gut" feeling since I started taking the Lialda that it is making me worse. Has anyone else noticed an increase in symptoms with Lialda?

 

[ravensfan88]

I've thought the same thing as you, but it's so hard to tell because the side effects of the Lialda are the symptoms of the disease... (for me, just D).

I've wanted to stop taking it and see how things go, but my GI said that Lialda should be making things better because the Remicade will bring the inflammation down to a level where Lialda can then start taking effect.

I don't know what to think though, tbh. Mesalamine is prescribed all the time so it must be doing what they want it to, though those side effects always make me a bit unsettled.

Anyway, let me know if you find out anything as I'd be curious to know as well. I'm taking 4 pills a day (the 4.8gm just like you) so if this is causing me more discomfort... well, I want something else!

 

[Thermo]

If you are not taking all of your medications due to side effects tell your doctor this is those exact words, they will find something else for you to take, i wouldnt rule out all mesalamine medication as you may not tolerate this one but another one might work for you.

 

[ravensfan88]

I've noticed an increase in symptoms (diarrhea) and discomfort with Lialda. It seems I will have much more gut activity for a day or two prior to passing pills during a BM.

This can be VERY uncomfortable and cause me to have to use the bathroom 2-3 times within an hour because it seems as if the undigested pills are causing a plug in my intestines or something and not allowing stool (loose/watery stool mind you) to pass or only pass little bits which leads to more trips to the bathroom.

I always find EXTREME relief after finally passing these pills.

I have been on Lialda since March and never saw a decrease in symptoms, only discomfort. Lialda is for mild to moderate CD (I have severe) and I was told it's used as a maintenance drug once Remicade can take effect and bring the inflammation or symptoms down to a level where it allows Lialda to also take effect.

I do not want to wait for this and continue to have issues. I'm going to stop taking Lialda, notify my doctors and ask for something else because this medication is not worth taking - at least for me.

 

[David]

I have been on Lialda since March and never saw a decrease in symptoms, only discomfort. Lialda is for mild to moderate CD (I have severe) and I was told it's used as a maintenance drug once Remicade can take effect and bring the inflammation or symptoms down to a level where it allows Lialda to also take effect.

Lialda is actually for mild to moderate Ulcerative Colitis. It, and no formulation of mesalamine have been approved for use in Crohn's Disease, some doctors just use it off label. Taking it a step further, I see Lialda being prescribed when people have small intestine disease when Lialda is formulated to treat disease in the colon.

I'd really love to know why doctors are prescribing it so often for Crohn's. I wonder if the drug reps are pushing it that way.

Here's an interesting read about the role of mesalamine in Crohn's Disease.

 

[ravensfan88]

Lialda is actually for mild to moderate Ulcerative Colitis. It, and no formulation of mesalamine have been approved for use in Crohn's Disease, some doctors just use it off label. Taking it a step further, I see Lialda being prescribed when people have small intestine disease when Lialda is formulated to treat disease in the colon.

I'd really love to know why doctors are prescribing it so often for Crohn's. I wonder if the drug reps are pushing it that way.

Here's an interesting read about the role of mesalamine in Crohn's Disease.

That article mentions Mesalamine being relatively safe.

Would that mean that Lialda is most like not causing my symptoms? Even though, in my opinion, the evidence is pretty huge.

 

[David]

By "pretty safe" they mean isn't going to destroy your liver or bone marrow or give you cancer kind of safe. It still has a nice list of possible side effects.

Mesalamine no doubt helps some with Crohn's disease. But I know many doctors are or have moved away from using it. If it's used in conjunction with other treatments, fine. But I always cringe when that's all someone is on and they're doing little or nothing else to manage their disease.

 

[ravensfan88]

By "pretty safe" they mean isn't going to destroy your liver or bone marrow or give you cancer kind of safe. It still has a nice list of possible side effects.

Mesalamine no doubt helps some with Crohn's disease. But I know many doctors are or have moved away from using it. If it's used in conjunction with other treatments, fine. But I always cringe when that's all someone is on and they're doing little or nothing else to manage their disease.

When I was first diagnosed, I was only on Lialda for about a month until my GI decided to start Remicade.

I really doubt Lialda is doing much of anything to help me right now and if may be adding to my diarrhea (along with the discomfort and issues with passing the pills during BM).

I appreciate your responses.

 

[KatyBuckeye]

Thank you so much for the links, David! I checked out the information...I had wondered why all of the clinical trial information on Lialda was for UC and not CD. I do think that the drug reps must be pushing hard for use in CD.

I have an update from my doctor and I would appreciate any input. I am so scared of things getting worse (my Crohn's is mild at this point) and I don't think I'm being treated appropriately. I told my GI that I had decreased the dose of Lialda to 2.4mg because of the increase in symptoms. I think that she was upset that I wasn't taking the prescribed dose (even though I had tried to contact her office multiple times about my issues) and the doc is convinced that the medication couldn't possibly be increasing symptoms. I asked her to what to expect as far as remission in Crohn's (how would I know if I was in remission) and her reply was that I could expect 1-3 loose BMs. Most days, I am within that range, but this is NOT normal for me! The GI said that most people with Crohn's always have loose stools. Prior to having acute symptoms of Crohn's, I had formed BMs every other day. Is that accurate information? Will I have diarrhea for the rest of my life?

The GI mentioned an option of starting a short course of steroids (she said for about 3 months). I don't feel ready for that, and told her my concerns about becoming prednisone dependent. She said, "Well, you WILL have to start biologics eventually." She ended the visit by telling me to keep the Lialda dose at 2.4mg and call her in 2 weeks to tell her how I'm doing. I am so upset after this visit! Is that really the choices that I have? Steroids and biologics?

 

[sfmreb2]

I reduced my Pentasa from 8 pills a day to 3. One with each meal. It is working great. My Dr told if it works go for it. I really like this GI guy. Pentasa had really increased my D. I have a theory but I'm on a tablet right now.:cheerss:

 

[David]

Katy,

In my opinion, everyone should strive for normal bowel movements. If you're having loose stools, that tells me you're not in full remission unless of course there are additional variables such as resection. That your doctor would be satisfied with you having 3 loose bowel movements a day is concerning to me. Of course, if she's only giving Lialda to many of her Crohn's patients, I'm not surprised that she thinks most Crohn's patients always have loose stools.

I PERSONALLY would try 3 months of total enteral nutrition before I tried 3 months of prednisone, but that's just me. If I absolutely had to take pred, I would, but I'd try a shotgun approach of other treatments first.

 

[ravensfan88]

I stopped taking Lialda on Thursday the 9th and have felt TREMENDOUSLY better ever since.

I feel like this drug has only been aiding to my suffering for the past 5 months...

The difference is seriously night and day. The first day was 100% better.

Reduced gut activity... better BM's (still D but better), more of a feeling that I voided, less urgency and frequency... everything is better.

I'll talk to my GI next week and see what he thinks and if he wants to put me on a different maintenance drug... but I don't want something that'll do the same thing Lialda did to me.

 

[michaelb]

Making Lialda work for crohn's

Lialda is intended for people with Colitis and those with Crohn's in their colon. If you have crohn's in the small intestine, it could get stuck, especially if you take multiple tablets at one time, making your symptoms appear to get worse.

Lialda, like Asacol, has a PH sensitive coating. If you have crohn's in your small intestine, since it's not going to dissolve until the PH approaches neutral acidity, it will bypass your disease before dissolving.

If you are willing to experiment, take an eXacto knife (or some other sufficiently sharp object), and scrape some lines into the pill's coating, such that you can see some grey through those lines. (rubbing an edge of the pill against a scissor blade should also work). This will allow some of the mesalamine to leak out of the pill before it reaches the ileocecal valve. According to the hypothesis behind doing this, the higher up your crohn's is, the more you should allow to leak out prematurely.

If you are a stickler for precision, you could test to see how much you want to leak out over time by placing a scraped tablet into a cup of acid (but don't drink from that cup till washing it), and observing it as you periodically agitate it.

 

[David]

Lialda is only intended for Ulcerative Colitis. Any use of it for Crohn's is off-label.

If you believe that Mesalamine will help your Crohn's disease of the small intestine, you could just ask for Pentasa instead of something so inexact.

 

[michaelb]

Lialda is only intended for Ulcerative Colitis. Any use of it for Crohn's is off-label.

If you believe that Mesalamine will help your Crohn's disease of the small intestine, you could just ask for Pentasa instead of something so inexact.

Unfortunately, the term "off label" carries a stigmatism that may imply to many that there have not been clinical trials to demonstrate the efficacy or lack thereof, of the medicine in question.

As far as Mesalamine for crohn's goes, there have been numerous such studies, but when a manufacturer's NDA claims that a drug is effective for more than one condition that it could be approved for, it needs to provide the FDA with additional data beyond the scope necessary for basic approval.

In a regulatory environment that allows for "off-label" use by prescribers, manufacturers are often satisfied to let such studies speak for themselves, and not undergo extra expense, unless there is a compelling reason to do otherwise. That is probably why all of the mesalamine drugs are only listed as being indicated for the induction of (and maininance of) remission in UC, yet physicians at most, if not all, of the major IBD centers continue to use tham as first line treatments for both crohn's and UC (based on the published results of the previously mentioned clinical trials, and their own experiences) a practice that tends to be copied by other GI physicians in their communities..

See for example: Lialda (Mesalamine) - Published Studies

The purpose of the experiment suggested was not to try a different sort of treatment, but simply an idea by which one willing to do so might be able to learn where the best (if any) release location for their individual case might be, especially useful to obtain data that might not be so easy to test for using existing unmodified "cookie mold" preparations.

As opposed to being "delayed" via a PH mechanism prior to release, Pentasa is a "controlled release" medicine (meaning it dribbles out the drug a bit at a time, a method antithetical to the desired experiment).

If I gave anyone the impression that I was suggesting a treatment modality, I apologize for my carelessness.

 

[ravensfan88]

Lialda is intended for people with Colitis and those with Crohn's in their colon. If you have crohn's in the small intestine, it could get stuck, especially if you take multiple tablets at one time, making your symptoms appear to get worse.

Every report I've read says I have Crohn's in the Large and Small intestine, not the colon.

What you said about the pills getting stuck is exactly what happens to me. It really did make my symptoms seem worse.

I am sure I need something, so maybe I will ask the doctor for Pentasa or at least see what he thinks.

 

[David]

There is a reason that mesalamine is not approved for Crohn's disease. From the study you linked to:

conventional statistical significance was not achieved.

And to those that did benefit many did so for only a short duration over placebo. There have been a ton of studies regarding mesalamine for Crohn's disease and none of them were very impressive. Considering that Crohn's disease affects every layer of the intestines and mesalamine's action is topical, that's not surprising.

Treatment with Mesalamine

- Early studies of 1-2g of Pentasa showed a lack of efficacy. 4g trials had conflicting results.
- A trial with 2g of Olsalazine showed no therapeutic affect and 22% of patients withdrew due to diarrhea.
- Salofalk versus corticosteroids showed steroids to be much more affective.
- In a study of patients with mild to moderate disease in the terminal ileum, patients were assigned asacol, asacol microgranules, or methylprednisone. Remission rates were about the same across the group.
- Pentasa versus Budesonide - Pentasa was less effective than Budesonide but as effective as 1g of ciproflaxin in inducing clinical remission.

Mesalamine for Maintaining Remission After Treatment with Other Medications
- In three studies with Pentasa in trying to maintain remission after treatment with other medications, there was no statistical significant between it and placebo.
- Two our of three studies with Claversal were negative.
- Salofalk and Asacol showed slight improvements over placebo.
- A Cochrane review (very strict) of 1420 patients found there was no improvement over placebo and didn't feel further study was justified. Ouch.
- Another study of 1305 patients found some benefit over placebo. A 6% benefit.

Now, I'm fine with mesalamine being given in conjunction with other treatment options. But I'm very concerned about the delivery mechanism of mesalamine formulations being messed with considering mesalamine is known to irritate the esophagus and stomach. And who knows what other potential side effects you increase the chances of. Why don't we try snorting it and see what that does?

If you want to change where your mesalamine is delivered, switch formulations to one designed for that purpose.

 

[ravensfan88]

There is a reason that mesalamine is not approved for Crohn's disease. From the study you linked to:


And to those that did benefit many did so for only a short duration over placebo. There have been a ton of studies regarding mesalamine for Crohn's disease and none of them were very impressive. Considering that Crohn's disease affects every layer of the intestines and mesalamine's action is topical, that's not surprising.


Now, I'm fine with mesalamine being given in conjunction with other treatment options. But I'm very concerned about the delivery mechanism of mesalamine formulations being messed with considering mesalamine is known to irritate the esophagus and stomach. And who knows what other potential side effects you increase the chances of. Why don't we try snorting it and see what that does?

If you want to change where your mesalamine is delivered, switch formulations to one designed for that purpose.

I am getting Remicade infusions since late April and have been on Lialda since March.

I do feel much better having stopped taking the Lialda since the 9th. The pills would get stuck... I felt a lot worse than I do now, since I stopped taking them.

Is there another medication you would recommend I ask my doctor for?

I think he wanted me to stick with the Lialda, but I can't handle it anymore. Maybe Asacol is an option (though when I was in the hospital, I had discomfort passing the coatings of the pills... I wonder if they will still get "stuck").

Or Pentasa? Maybe a whole different type of drug altogether?

Thanks in advance for your response.

 

[David]

If you're so strictured that pills are getting stuck, then mesalamine isn't going to do much for you in my opinion. Certainly not Lialda if it's small intestine stricturing.

I'd go for the shotgun approach of Remicade and total enteral nutrition. Maybe LDN and medical marijuana if they're available to you.

 

[ravensfan88]

If you're so strictured that pills are getting stuck, then mesalamine isn't going to do much for you in my opinion. Certainly not Lialda if it's small intestine stricturing.

I'd go for the shotgun approach of Remicade and total enteral nutrition. Maybe LDN and medical marijuana if they're available to you.

Yea, I'm on the TPN still but I think I may be taken off of it soon. It's been over 2 months.

As for the LDN, I asked another GI (Dr. Mary Harris, known as one of the best doctors for CD) about it and she said that the tests or trials she looked at... she didn't really think it was something worth looking further into. That doesn't mean she is right, however. I will ask my actual GI about it and see what he thinks.

Also, Maryland has not legalized medical marijuana yet so that's unfortunately not an option.

Thank you for your response.

 

[KatyBuckeye]

None of my tests show Crohn's in my small intestine, so I don't think it was an issue of the pill getting stuck for me. I decided to stop the Lialda. Initially, I was worse for a few days...but things are looking very promising today. If anything, I really don't think the Lialda was helping. I finally found a provider to prescribe low dose naltrexone, so I'll be trying that next.

 

[Thermo]

Let us know how your naltrexone treatment goes, good luck!

 

[ravensfan88]

I would also like to say that since stopping Lialda, I have cut down my BM's from 4-6 very loose, diarrhea to 2-3 more formed stools.

This is absolutely amazing to me.

I talked to my GI and we both agreed that I don't need anything but the Remicade right now, since I'm doing better and I'm due to have an increased infusion on the 21st.

The Lialda really was giving me some terrible side effects and I'm glad to no longer have that suffering.

Thank you, KatyBuckeye, for posting this thread because I may have never "looked deeper" into my issues if it weren't for this.

 

[David]

That's wonderful. I'm so glad to hear you're doing better!

:dance:

 

[KatyBuckeye]

That's great, Ravensfan!!! So glad to hear that things are going better for you. I'm also feeling much better off the Lialda- much less urgency and frequency. Good news for both of us.

 

[AnnaB]

Under my original diagnosis of UC, my doctor gave me Asacol but switched me to Lialda. During the week-long break from Asacol while I waited for my Lialda to come in, I experienced what seemed like remission. I had zero symptoms and felt a million times better. Then, once starting the Lialda, my symtoms returned and were worse than on the Asacol. After two weeks of feeling terrible, I went off all medication and ended up in remission for four months.

 

[KatyBuckeye]

I just wanted to update everyone on my experience. As posted above, I stopped the Lialda a little more than a month ago. It was most definitely causing me increased symptoms. I've been sticking to my diet and taking various supplements and I'm now at a point where I'm not having any GI symptoms, except for some minor RLQ pain, which I've had on and off for many years. I still have some joint pain, but it's decreasing. I switched GI docs and I'm now seeing one of the best IBD doctors in my state. He says that Lialda is not a drug that he personally prescribes for Crohn's because he doesn't feel that it's that effective. He also said that 1 in 20 people will experience drug-induced colitis from Lialda. So, if you are experiencing increased symptoms, make sure you bring it to the attention of your doctor.

 

[David]

That's wonderful Katy! I'm so glad you're doing better

And I'm not in the least surprised that a top Crohn's doctor doesn't prescribe Lialda.

 

[Calypso]

I don't know if this will help anyone or not, but I have Crohn's in my large intestine and Lialda is the best one that has worked for me. I tried Asacol and Pentasa before (the Pentasa made me worse). I think maybe for certain people different medications will help and the thing I really appreciated about my doctor was that she would listen to me when I said a certain medication was making me worse. Sometimes I had to be direct and say "you need to try me on something different".