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.

7 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?

  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.

  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.

  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)

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