FDA Reports of Crohn’s Disease Treatment Side Effects Have Increased, Analysis Finds

FDA Reports of Crohn’s Disease Treatment Side Effects Have Increased, Analysis Finds

Drugs used to treat Crohn’s disease and other autoimmune disorders are among those with the greatest number of reported side effects filed with the U.S. Food and Drug Administration (FDA), according to a USA Today Network Exclusive analysis.

The analysis found an increase of five times the number of side-effect reports to the FDA in 2015 from 2004 for all drugs, amounting to more than 1.2 million reports of side effects in 2015.

Drugs which suppress the immune system to fight inflammation can cause serious and sometimes lethal infections including tuberculosis, and have been linked with blood disorders, including lymphoma, a blood cancer.

Humira (adalimumab, manufactured by AbbVie), an FDA-approved monoclonal antibody that targets tumor necrosis factor alpha (a pro-inflammatory mediator that plays a critical role in inflammatory diseases), is one of the most widely used drugs to treat Crohn’s and other autoimmune disorders.

Humira is indicated to treat children and adults with moderate to severe Crohn’s disease to reduce signs and symptoms of the disease and maintain clinical remission.

However, according the new analysis, the use of Humira has been linked to more than 200,000 reports of adverse events, including 4,200 deaths.

But the authors of the analysis consider that the surge in side-effect reports could indicate a growing number of harmed patients or more vigilant reporting of adverse events, a goal the FDA is aiming to achieve. Experts consider that both likely play a role.

Humira can also cause hepatitis B infection in carriers of the virus, allergic reactions, nervous system problems, blood problems, certain immune reactions including a lupus-like syndrome, liver problems, and new or worsening heart failure or psoriasis. Doctors should carefully consider these when prescribing the drug to patients.

Crohn’s disease is one type of inflammatory bowel disease (IBD) that causes chronic or recurring immune response and inflammation of the gastrointestinal tract, from the mouth to the anus. Symptoms include abdominal pain, diarrhea, fever, and weight loss. Other complications may occur outside the gastrointestinal tract and include anemia, skin rashes, arthritis, inflammation of the eye, and tiredness.

According to the U.S. Centers for Disease Control and Prevention (CDC), there are an estimated 1 million to 1.3 million people who suffer from IBD. The cause of the disease remains undetermined.

11 comments

  1. Pamela says:

    Right, OK. So now that we have been informed once again of all the wonderful thongs that Humira could do to its users, what is your suggestion??? Do the benefits out weather Rick’s? YES OR NO? ANY DATA ON THIS, OR DO YOU JUST LIKE TO ALARM HELPLESS SICK PEOPLE LIKE MYSELF?

    • Robin Throw says:

      Yes I have been on humeria for 6 years and my crohns has been in remission for as long as I have been on it, mine acts differently the only way to tell if I am having a flare up is to do a colonoscopy and biopsies because the doctor can not see it and I do not have the regular symptoms, the only way the doctos found out was my colon collapsed and perforated. They have to ppst side effects it doesnt mean that it will happen, and in most cases in studies the people already have side effects before taking humeria or others but they have to report it and use it in study, trust me talk to your doctor’s and please do not say no until you get all the facts. This disease can kill you….

  2. Craig says:

    This is why I don’t want to come off of a low dose of steroid and take a biologic drug. My doctor said Prednisone is dangerous, but in my case I have had few side effects, none of which are harmful. Yet they want me on one of these instead. No thanks. I would rather take Prednisone until it no longer works for me.

    • Cecilia says:

      The long term side effects of steroids are quite bad though. I know of people that has been on it for a long time and they all got severe osteoperosis for one thing.

  3. Linda Storm says:

    I also have been insistent that my son not be treated with biologics… We opted to go the surgical route — best thing we ever did, but I had to fight for it.

  4. Arnette Bowman says:

    I was taking Humera but less than 6 months into the treatment my feet hurt so bad I literally could not walk due to nerve pain. I went to my nurologist and found out I have neuropathy. I will have this damage to my nerves for the rest of my life.

    • Cheryl says:

      My husband spent 10 years on remicade. He too has peripheral neuropathy. But NOTHING else helped him. He was in and out of the hospital, fed through a pic line, we are convinced he would not have survived. He went off maybe 2 years ago. He takes entocort now, it helps but not like remi did. But it is a steroid…since he is having pain they want to put him on Entyvio. It is a biologic but it does not cross the blood-brain barrier (less likely then to cause neuropathy). He hasn’t made the decision yet. But then…a battle with the insurance company…

  5. Joy says:

    I have Crohns and take NO meds at all, I sometimes consent to Budesomide steroid as it is gentler on the body, I read the side effects of the drugs used for Crohns, there is no cure so would rather take risks than subject my body to more destruction

  6. Michelle says:

    I developed Chronic Mylogenic Leukemia while taking Humira. The oral chemo to treat it costs over $13,000 a month. My insurance company rejected the reorder due to the high cost. This is terrifying!

  7. Nicola Price says:

    Anti-MAP treatment is an option that is becoming more widely used for Crohn’s. If / when humira stops working for you, it is worth having the discussion about the triple antibiotic therapy with your specialist.
    (See FAQ7 on Crohn’s MAP Vaccine website)

  8. Jay says:

    From a very concerned father:

    My son is taking Humira for Hidradinitis Suppurativa.
    I have read that it can cause severe depression and even suicide. Anyone taking Humira experiencing severe depression and or suicide thoughts?

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