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Posted 4/18/2011 1:23 PM (GMT 0)

Hi all,

I haven't been on the board in a long time as I have been enjoying a wonderfully long remission. 

I received an e-mail on Friday from the FDA (how they knew to get in touch with me, I don't know) regarding them changing their warnings about people taking Imuran and / or anti TNF meds and a rare form of lymphoma.

Have any of you guys also received that warning and are you considering changing your drug regimen?

Thanks all, this has gotten me a bit worried.

Jen

Posted 4/18/2011 1:27 PM (GMT 0)
I didn't get anything but what did it say?
Posted 4/18/2011 1:39 PM (GMT 0)
I don't know if links are allowed but here it is:  http://www.fda.gov/Drugs/DrugSafety/ucm250913.htm

[04-14-2011] The U.S. Food and Drug Administration (FDA) is informing the public that it continues to receive reports of a rare cancer of white blood cells (known as Hepatosplenic T-Cell Lymphoma or HSTCL), primarily in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with medicines known as tumor necrosis factor (TNF) blockers, as well as with azathioprine, and/or mercaptopurine.

FDA believes the risks and benefits of using TNF blockers, azathioprine, and/or mercaptopurine should be carefully weighed when prescribing these drugs to children and young adults, especially for the treatment of Crohn’s disease and ulcerative colitis.

(a couple of quotes from the statement)

Jen

Posted 4/18/2011 2:06 PM (GMT 0)
I didn't know this was news. It seems like those patients must be on higher doses. I've really only heard about it happening to people taking the drug for transplants, which require a higher dose.
Posted 4/18/2011 2:53 PM (GMT 0)
What is considered a high dose?
Posted 4/18/2011 3:06 PM (GMT 0)
This is in specific reference to UC and CD Patients...

Posted 4/18/2011 4:46 PM (GMT 0)
Thanks for the link. Links are allowed so long as they are not for the purpose of selling or marketing a product. Your link clearly isn't. I saw an article about this the other day but it sounds like the same risks that have always been a factor with these drugs.
Posted 4/18/2011 6:10 PM (GMT 0)
OK, I am glad...Thanks for easing my mind a bit...I was thinking that this was even an INCREASED risk than what I had been told about before...

Be well all!

Jen O
Posted 4/18/2011 6:55 PM (GMT 0)

ElephantPipe said...
I didn't know this was news. It seems like those patients must be on higher doses. I've really only heard about it happening to people taking the drug for transplants, which require a higher dose.

They are talking about patients who are being treated for Crohn's disease and UC, not about people who are taking the drug for transplants.

Jen O said...
OK, I am glad...Thanks for easing my mind a bit...I was thinking that this was even an INCREASED risk than what I had been told about before...

Be well all!

Jen O

I think that's the point. The FDA says that they are "continuing to receive reports," which means that it could very well be a higher risk than first believed.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyalertsforHumanMedicalProducts/ucm251443.htm

I just don't understand why people would want to risk getting life-threatening infections and cancer just to save their colon.

Post Edited (subdued) : 4/18/2011 1:11:39 PM (GMT-6)

Posted 4/18/2011 7:09 PM (GMT 0)
I agree -- It would be interesting and helpful to know what dose the patients were taking. However since it does specifically state they were taking it for IBD I would suspect it wouldn't be out of the norm which I've seen to be anywhere between 25mg and 200mg a day.

To me it sounds like the only new part in all of this is that they have now seen cases of this lymphoma in patients who are taking ONLY azathioprine/mercaptopurine whereas previously it appeared to affect only those who were taking those medications in conjunction with TNFa blockers like remicade.

I just recently started azathioprine, so yes this does concern me but I'm not ready to give up on it yet. Its only been a couple of weeks so I have no idea if it is even working yet. If it does work and I finally acheive remission I may consider trying to ween off the aza and see if I can stay in remission using diet and other alternative methods. If that failed I could always go back to the aza.

Obviously if I ended up with fatal cancer from taking aza I would be devastated but at this point I ask myself what is the point of living if you have no quality of life. So I guess achieving remission is my number one goal right now. Once I get there I may adjust my treatment plan based on studies like these but for its just a risk I have to live with.
Posted 4/18/2011 7:10 PM (GMT 0)
I had understood previously that it was not recommended to take azathioprine or imuran with remicade for a long period of time. In reading the article it sounds like they are continuing to report on this.

Thanks for sharing, it is good to be informed.
Posted 4/18/2011 7:13 PM (GMT 0)
I think the use of immunosuppressants (Imuran and 6MP) is far safer than the use of Remicade.

Sue
Posted 4/18/2011 7:34 PM (GMT 0)
In some ways I agree with you Sue. Imuran and 6mp have been around for much longer. Hopefully they continue to do tests with Remicade and other biologics and see that they are safer but right now, I don't think there is any way to know.
Posted 4/18/2011 9:19 PM (GMT 0)
"I just don't understand why people would want to risk getting life-threatening infections and cancer just to save their colon."


That would be because we're stupid, I guess.
Posted 4/18/2011 9:51 PM (GMT 0)
In regard to taking heavy medications only to ween off them by using diet and alternative methods, not unless you are in a life-threatening flare, is it necessary to take heavy medications because if using diet and other alternative methods will keep a you in remission, then they will also get you into remission.

In regard to using heavy medications to have a quality of life, there is no guarantee that taking heavy medications will give you a quality life. I've also been reading on the forums that people who get colon surgery are finally able to get their life back and have a quality of life. So there is no need to take heavy medications in an effort to have a quality of life.

I think what surgery is really about is making an irreversible decision. Very few decisions are irreversible, and many people have a very difficult time making them. They would rather try everything possible, even if those options have serious risks, then to make an irreversible decision.
Posted 4/18/2011 10:01 PM (GMT 0)
I guess I am, too, one of the stupid ones as I have taken both Anti TNF medications (Remicade) and Imuran...

I guess right now I would rather be taking these meds than being without my colon and taking around the clock narcotics. I am in a remission that has lasted nearly 2 years now and am quite a happy person with these (expensive) meds.

"Natural" remedies did not work for me as diet has no impact on my symptoms.

Jen O
Posted 4/18/2011 10:44 PM (GMT 0)
Jen O, what around the clock narcotics? I had j-pouch take down surgery 2 weeks ago today and even I am not on narcotics. For the first time in 5 years I am completely off prescription medication!!! I don't miss my diseased colon at all.

It is so sad that they can't find drugs that aren't so life threatening.
Posted 4/18/2011 11:51 PM (GMT 0)
www.internalmedicinenews.com/news/oncology-hematology/single-article/rare-lymphoma-reports-continue-in-young-patients-on-tnf-blockers/fe1824f114.html

At the bottom of the article shows how many people got lymphoma from taking these medications.
Posted 4/19/2011 2:32 AM (GMT 0)
Yes, what round the clock narcotics?

I had my jpouch surgery 10 years ago and have been med-free since. Surgery eliminated the need for me to take prescription drugs, hooray!

Sue
Posted 4/19/2011 3:12 AM (GMT 0)
I am not surprised to hear that these drugs are known to cause cancer. about 2 1/2 years ago I was having a particularly nasty UC flareup & when the Prednisone, Salofalk and Colofoam weren't doing their job, the doctor prescribed Imuran. My second day taking it I became violently ill, vomiting every 5 minutes for more than 2 hours. I couldn't move & hadn't so much as a drop of bile left in my stomach at the end of the ordeal. It was a strong message from my body that this medication was nothing more than poison.

I ended up checking into the hospital for a week, got a little treatment & upon arriving home made a decision to take control of the situation. The drugs simply weren't working - they were just fattening the pockets of the pharmaceutical companies with no benefit to me at all - all they gave me were rotten side effects like weight gain, a depleted bank account and ultimately - depression. My doctor told me that my UC had become so bad that if I had another flare up I'd need a colostomy bag which for me just isn't an option.

I made a connection that certain antibiotics were responsible for the flareups I had endured and decided never to take them again. Instead, I took Aloe Juice, Probiotics and L-Glutamine and within weeks of being home from the hospital, I was feeling better than I had in years. I eventually went off the Salofalk as well. Two years on and I remain in remission, am totally drug free and feeling great. My doctors probably think I'm a crackpot for blaming the antibiotics, but there was a definite pattern. Anyway, antibiotics are over prescribed and they are known to not only cause UC but exacerbate it as well.

Everyone's story is different & we all do what we can to get through it. A treatment that works for one person may not work for the next. After all we are all unique individuals. We are not stupid or idiots for listening to the doctors or trying whatever treatment is suggested to deal with this ugly disease. We also aren't stupid for trying alternative therapies or for making the decision to have surgery. We must do what works for us.
Posted 4/19/2011 3:29 AM (GMT 0)
It's not stupid. The risk is still very low. I take 6mp, there is risk there too!
Posted 4/19/2011 6:41 AM (GMT 0)
Decisions we made in the past that we regret making are sunk costs. I have many. A few are really huge. It's important that we neither rationalize them nor dwell on them. Rationalizing them will cause us to make the same mistakes. Dwelling on them will only make us depressed. Past decisions are over and done with. Their value is only in whether or not we learned from them so that we make better decisions in the future.
Posted 4/19/2011 11:35 AM (GMT 0)
ucisapain said:
Everyone's story is different & we all do what we can to get through it. A treatment that works for one person may not work for the next. After all we are all unique individuals. We are not stupid or idiots for listening to the doctors or trying whatever treatment is suggested to deal with this ugly disease. We also aren't stupid for trying alternative therapies or for making the decision to have surgery. We must do what works for us.

subdued said:
Decisions we made in the past that we regret making are sunk costs. I have many. A few are really huge. It's important that we neither rationalize them nor dwell on them. Rationalizing them will cause us to make the same mistakes. Dwelling on them will only make us depressed. Past decisions are over and done with. Their value is only in whether or not we learned from them so that we make better decisions in the future.

I really enjoy reading posts like these and similar. So intelligent and open-hearted. Thanks.
Posted 4/19/2011 1:37 PM (GMT 0)
Another stupid one here, that must be me! I have been taking 150 mgs/day of Imuran, initially with a high dose of Remicade, then Humira, for going on 4 years now. OF COURSE the cancer risk worries me, much more so now than it ever did before- as it's looking like these meds are the only things that make a dent in my UC symptoms. I have started to weigh the pros & cons of surgery vs. meds, & honestly, surgery is starting to look like a far better alternative. When I first started on these meds, I figured that I could only worry about my life NOW, not what may happen down the road. Now, as I'm on that road with no sign of stopping, I'm beginning to realize that this is not perfect, that even with the meds my life NOW is not so great, UC-wise. But to question someone's decision to use these meds is a low-blow. Very low! I'm sure everyone taking them worries about the cancer risk, & has thought about it countless times. It's not a decision made lightly, so plse. don't throw out comments like that lightly. That old adage about "walk a mile in someone else's shoes" is very apt here.

Posted 4/19/2011 1:50 PM (GMT 0)
Judy 2-I guess I'm one of the stupid ones also.  I went on remicade two months after being diagnosed with severe uc throughout my whole colon.  I was allergic to all 5 asa's and 6mp.  I was in a constant flare for a year and a half.  I was so bad.  I could try the remicade or have surgery.  My doctor said that the risk of cancer is 1 out of about 1,000-1,500.  Surgery isn't without it's problems either. I have read on here about people having surgery and they have nothing but problems and are on remicade, 6mp, or humira after they had surgery.  I don't like being on remicade but I don't like the surgery option either.  We should not judge people that are on the drugs or that had surgery.  Every one is doing what is best for them.  We don't have many options when diagnosed with uc/crohn's.  The meds are all scary and the surgery is scary also.  I don't like this uc thing at all.  I live in fear being on the remicade. I have young kids at home but surgery for me right now is fearful also.  I choose remicade because my kids are young and I was hoping to get a few years before the surgery.  That way my kids were older when I had it.  We were all dealt bad cards lets encourage not question others.  Did they say how many people world wide are on these drugs and have been fine and never got cancer.  I'm sure it is 10,000 plus at least.  So, are the risks really that bad?
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