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New FDA Update Regarding Humira Being Approved for Colitis

Quick Update for all of you who are wondering about and/or interested in the followup regarding the FDA’s approval of Humira.

Back in August (link to original story-here) you may remember we talked about the approval process that the Food and Drug Administration was taking regarding Abbott Laboratories anti-tumor necrosis factor (TNF) medications that blocks proteins that play an important role in abnormal inflammatory and immune responses.  Well, just yesterday, they made a public announcement about their decision to move forward with medication being approved for moderate to severe ulcerative colitis patients as a potential treatment.  Obviously this is a huge win for Abbott Laboratories, and you can read the direct news release from the FDA website here if you like:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm321650.htm

Also, there is a category setup on this website with stories related to Humira if you are interested in learning more about UC’ers experiences, that link is right here:  http://www.ihaveuc.com/category/ulcerative-colitis-drugs/humira/

Back during the August FDA Gastro meeting, where Humira was being reviewed, there was a request for the manufacturer to supply some more clinical trial information, and I’m assuming that Abbott has finally satisfied the FDA with that request which prompted their press release yesterday.

Alrightee, talk to you all soon,

-Adam

Tags: Humira





21 Responses to “New FDA Update Regarding Humira Being Approved for Colitis”

  1. BevSeptember 30, 2012 at 7:15 am #

    Man, tho, after seeing the humira commercials on the tv….the side effects are downright scary…may cause death in rare cases (I always seem to be that rare case)…what else is new, huh?

    I can’t wait to see commercials for PROBIOTICS to treat tons of different diseases including UC…and the side effects?

    NONE!!!!

    Oh happy days…

  2. BevSeptember 30, 2012 at 7:17 am #

    Oops, I’m not ‘dead’ yet…duh(!)…I just mean that I seem to always be that ‘rare’ case when if comes to UC drugs and the side effects!

    Sorry y’all…bad choice of words there.

  3. Jess
    jessicaSeptember 30, 2012 at 9:32 am #

    Well after having my colonoscopy last week and being diagnosed with crohns disease now instead of uc, i sure hope humira doesnt kill me. Im running out of options! You name it, I’ve tried it…probiotics, l-glutamine, aloe vera, scd diet, digestive enzymes, peppermint oil, lialda, steriods…the list goes on and on. In fact 6 months later, Im still on all of the above and instead of things getting better they are getting worse. In December I try Humira and im praying for a miracle. Im so happy to hear you are in remission Bev with the things you’ve tried, but some of us are just not that lucky. Saying scary things about drugs that may save some of us, is just not helpful sometimes. Not trying to stir the pot, just a scared momma trying to get better.

    • BevSeptember 30, 2012 at 9:50 am #

      Gosh, I’m so sorry Jessica! I spout ioff a bit quick, sometimes without thinking….my bad.

      I know we are not all the same, and I know how lucky I got that these things are actually working for me!

      Please…nobody be offended, or do anything rash based on what I SAY. We are all so very different in our diagnoses (plural) and in the particular way this disease manifests itself in each one of us. I always say, what works for one, does not necessarily work for another. It’s just that those freakin’ commercials are so damned scary…maybe they should not state ALL of the possible side effects on the television…leave that to the doctor’s office, right?

      Again, Jessica, I meant no harm. My old body just cannot tolerate the drugs…I feel so bad now…

      I apologize EVERYONE.

    • shelly in maineSeptember 30, 2012 at 11:43 am #

      Jessica,
      It is important to listen to others’opinions and info. Bev is soooooo excited and never ill-meaning if you read her posts.
      It is true about all the meds having many side effects…I can tell you that from actual experience. I too took them all and was forced into no meds by becoming intolerant and/or allergic to them all….not to scare you, but make you more aware of the potential side effects so YOU can be part of the decision process…no one knows your body like you. By the way, I am in remission for over a year, Med free, only on probiotics-very high dose of vsl 3 prescription strength and omega 3’s-4 g….I am 44 and diagnosed at 15 on sulfa. Drugs 2 years prior. And fyi…from everything I’ve read…some of those things you are taking can actually cause some of those problems, too…I do recommend scd or some diet I am not strict, and the probiotics and omega all harmless and no reported side effects…you have to work up with a good quality probiotics and give it some time…it can’t hurt no matter what you end up doing.
      Best, Shelly

    • shelly in maineSeptember 30, 2012 at 11:50 am #

      Jessica,
      My other post is awaiting moderation, but I was also wondering why not remicade first…it is usually tried before humira because of how it is made you are less likely to reject it. By the way, there are discount programs for those meds….VERY EXPENSIVE. Please do your research.
      Best, Shelly

    • Jill
      JillOctober 1, 2012 at 6:10 am #

      Jessica,
      You make sense to me! I have taken and tried everything and didn’t work….except humira….brought me into remission and gave me pustular psoriasis….had to quit humira but was in remission for 3 years…diet and probiotics for that time…as a suggestion…during the time of remission and no meds after a year or so I qualified for disability insurance that didn’t have UC as a pre existing condition…..Huge benefit as I was a single mom too…

      Anyway I leave today for mayo clinic to have my j pouch constructed. I have a peace in knowing I tried everything. There is a little spot in there that wonders what may appear later from all the drugs but hey look what UC makes appear. The disablity insurance will help keep me afloat while I recover. I can thank humira for kicking UC butt. Wish you remission soon!

      ps…was just thinking this am…as i cried on my wonderful husbands shoulder…i cried a lot being diagnosed….all the unknowns to come….you would think after 10 years of this disease destroying my life nothing would phase me…the unknown of how this surgery will effect me…sounds silly but scared of what it will be like to have my life back…not just wish anymore..

      Jill

      • Jess
        jessicaOctober 1, 2012 at 10:31 am #

        Jill, I wish you the very best. I hope your recovery time is quick and you get to live a life without the constant fear of the next flare. You get to actually live again!! Thank you for understanding my comments. I, like you have tried it all and am slowly realizing there is no right or wrong answer. If it was as easy as a few probiotics here and there, we wouldnt have this site. All the medicines sound dreadful, but so does having my health on a constant downward spiral all while im doing everything i feel i possibly can. if i have to take humira, then all i can do is hope and pray it works. i just want some belly peace!! unfortunately, now that my diagnosis has been changed to crohns i dont think a jpouch is as practical or even possible like it once was. it always felt like a real possiblity to me and im sort of sad its not an option anymore.

        Best of wishes to you today! You are going to do great!

        • Jill
          JillOctober 1, 2012 at 3:05 pm #

          You are right with the j-pouch surgery. Not for crohns. They said there is a 2% chance even after all the extensive tests mayo did. Once they remove the colon it gets sent to the pathologist for the final test before they construct the pouch. I agree that an accurate diagnosis is important for treatment options. Up at mayo they said there were more treatment options if I had crohns. Keep us posted on how you are doing!

  4. Jess
    JessicaSeptember 30, 2012 at 5:38 pm #

    Thank you ladies. Really wasn’t trying to jump down anyone’s throat. Just having a really hard time digesting my news. I feel as though I have tried everything. I know there are side effects of the drugs but the side effects of not trying everything to fix this has side effects too. Shelly, I’m using top if the line probiotics not culterelle or anything if that sort so that isn’t helping. What from my list have you heard make things worse. Please do tell because I am very open to feedback as I am desperate. Again Bev, maybe a little jealousy in my first post and frustration with my own state of health. Best of wishes on your recovery.

    • shelly in maineSeptember 30, 2012 at 6:16 pm #

      Jessica…don’t worry we all get stressed. Most all those things have side effects except probiotics. Bev takes one that works for her and I take the Vsl3-Rx. Meds and herbl meds can cause things similar to what they are trying to fix-you really have to research research, research it s the only way to empower yourself no matter your route. You may only want to add 1 thing at a time-kind of restart and write everything down…input, output,etc so you know what works and what doesn’t. It is tedius, but well worth it.
      Not sure your whole situation/status…the doctors will always push meds and will disregard the side effects…it is up to you to help them especially if you are on traditional meds. Read some of Adam’s surveys and stories under the meds. I still think you should talk to your doc about all options-especially the remicade. I had 3 pretty good years on it-and you are monitored at hospital or similar facility…the Humira I needed-I guess to get out of an extremely bad flare, I was allergic the whole time I could tell, and even had a heart stress test to make sure I was OK- I needed the bleeding to stop as I was not ready to end my battle with uc and have surgery. I am now at a poin. t that I refuse to take any more toxic drugs…humira gave me some lasting effects and it is 1 of the meds I do regret…however, it
      may work for you.
      Sorry to ramble…the other concern is making sure your diagnosis is correct-there are plenty of stories on wavering diagnoses-and do you have a good gi…my primary care doc is a D.O. and has helped me tremendously and he is the one that recommended probiotics and omega 3’s.
      Knowledge is power…Best, Shelly

    • BevOctober 1, 2012 at 6:25 am #

      LOL…No worries Jessica! We’re all the same here. We all have the dreaded UC….AND mine could flare up at any time again. I know that. I do live in that secret fear. I think we all do. It’s always in the backs of our minds. Tiring…

      I just want us all to be cured. CURED. Not band-aided with these meds, you know what I mean? They don’t really cure us, because we all continue to live in this ‘fear’ of the flare. I want that to disappear!

      Cheers:)

  5. Jess
    JessicaSeptember 30, 2012 at 5:39 pm #

    Realizing how bad my phone typo is…sorry

  6. shelly in maineSeptember 30, 2012 at 6:29 pm #

    Food for thought….I think the length of the commercial and perhaps the number of times they are on(and this applies to all meds) correlates directly with its side effects and toxicity!!?
    Boy, aren’t those humira commercials long?! :-) :-) :-) just a thought/observation, shelly

    • BevOctober 1, 2012 at 6:21 am #

      Yes, Shelly…isn’t that the truth…humira commercials ARE very long. Too long!

  7. JamieIsLame
    JamieIsLameOctober 1, 2012 at 8:17 am #

    I asked my doctor to put me on Humira back in March before starting Remicade, he thinks we went for the better option with Remicade.. I do agree, but now I know this medication is approved too! apparently it stings like a bi-atch though.

    It’s still great news that it’s approved for all us UC’ers out there who might need it, although, some doctors were already using it as a treatment for their patients.

  8. Erin
    ErinOctober 10, 2012 at 8:36 am #

    now that its approved and my insurance finally decided to cover it my doc wants to start me on it right away
    Friday is my first dose, im super nervous about it because of all the possible side effects and of course the self injectable part =/
    its supposed to work really good though so im a bit excited to hopefully get rid of all my symptems though!
    wish me luck

    • AdamOctober 10, 2012 at 8:37 am #

      Good Luck with it Erin!!:)

    • JessyOctober 16, 2012 at 11:38 am #

      Hi Erin, I’ve been on Humira for about 5 years now. Before I started taking Humira, I would continuously end up back in the hospital from how bad my flair ups would get. Since then, it has kept me out of the hospital and helping me keep a sort of normal life again. At first, they were hesitant to put me on Remicade so they gave me Humira. It was fairly new and not many stories or even commercials were out, now I see them every time I turn on the T.V.! In the past, whenever my doctor tries to wean me off, it gets bad and I end up back in the hospital. I take it every two weeks as an injection in my stomach. You could also take it on your arm or thigh, but I feel safer with my stomach. Although there have been times where I don’t push it in my skin hard enough and I poke myself or I’ve put it in the wrong spot and when I go to take it out I start to bleed. I’m not trying to scare you or anything, just sharing my story. Although it has many side effects, I can’t complain about the drug or say I’ve suffered the side effects. With all the medicine one takes for UC and the actual disease, you’ll never know the reason for your headache or fatigue. I’m not completely in remission, but I’m fairly close. I get stomach pains every now and then when I go to the bathroom or when I eat certain foods. Humira might not work for everyone, but it definitely worked for me. I hope everything goes well and the medicine helps you!

  9. faridah matosDecember 29, 2012 at 10:48 pm #

    hi my name is faridah, this is my first time posting anything on here. I have quite a few questions for anyone out there that can help me, I was diagnosed with uc two years five months ago and i have been through every medicine you can name.(asacol,lialda, prednision, 6-mp,etc). I am now on 10mg prednisone/day, lialda 2pills 2x’s/day, and remicade infusion every 6 weeks. I have just had my fifth infusion yesterday and my doctor told me that from a recent ct scan the remicade is not working anymore. ; ( I have spoken with my doctor about switching to humira but i am a little hesitant about it. I guess i have no choice though i am having a pretty bad flare right now going to the bathroom 10+ today alone. I just need help and someone to talk to i feel so lost and helpless.

    • AdamDecember 30, 2012 at 12:05 am #

      Hey Faridah,

      Your situation sounds pretty similar to what was my deal about 3 and a half years ago. I too went up the line with the medications with little/no positive long term results. After remicade and humira i was looking into surgery.

      have you already tried alternative treatments such as diet ?

      That in the end is what has worked the best for me over the past 3 1/2 years.

      -Adam

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