Severe arthritis

Humira (adalimumab) is the best selling drug (in dollars) in the U.S. (and around the world). Sales were listed between $13 and $16 billion in 2016. That is an unbelievable amount of money for a single medication. To put it into perspective, the first billion dollar drug in America was Tagamet (cimetidine) for ulcers. In 1987 people considered its sales of of $1.13 billion unprecedented. Physicians prescribed Tagamet for a wide range of digestive disorders affecting millions of people.

Humira: Huge Sales Despite Orphan Status:

It’s not because so many people take Humira that it earns so much money. Humira is categorized as an orphan drug to treat juvenile rheumatoid arthritis, Crohn’s disease and uveitis (a severe inflammatory eye disease). Orphan status provides special perks to drug companies (see this link for more details).

Orphan drugs were once considered unprofitable. The Oxford American Dictionary defines an orphan drug as “a pharmaceutical that remains commercially undeveloped owing to limited potential for profitability.” The FDA originally considered such medications as “significant drugs of limited commercial value.” Clearly, that is not the case for Humira.

A carton with two prefilled syringe “pens” of Humira can cost over $4,500. At that price it is easy to understand how the sales of this injectable medication have soared. People generally get an injection every other week (two shots a month).

Other “indications” for Humira include rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and moderate-to-severe ulcerative colitis. Many people consider Humira a miracle. Others see Humira side effects as worrisome. We’re going to provide the pros and cons so you can determine the benefit/risk ratio for yourself.

TNF (Tissue Necrosis Factor) and Your Immune System:

When your immune system detects something out of whack in your body it activates compounds designated tumor necrosis factors (TNFs). Whether it is a bacterial infection or a viral invasion, TNF is created to fight off the foreign invaders. If you come down with the flu your body will make TNF as one of the first lines of defense to combat the virus (Journal of Virology, Feb., 2002).

If “tumor” and “necrosis” caught your attention you are also on target. Necrosis comes from the greek word nekrosis, which means “becoming dead” or the death of cells or tissues. In other words, tumor necrosis factor has anti-tumor activity and may play a key role in cancer detection and therapy (Oncotarget, Oct., 2011; Chemical and Pharmaceutical Bulletin, online, July 14, 2017).

The First TNF Blockers: Enbrel, Remicade and Humira

First came Enbrel (etanercept) in 1998. It was designated a “biological” drug in that it was created by utilizing human DNA transplanted into ovarian cells of hamsters. This led to the creation of proteins that had been genetically engineered. It was called a TNF-inhibiting drug in that it grabs onto tissue necrosis factor. Remicade (infliximab) came next in 1999. This monoclonal antibody (“mab“) blocks tissue necrosis factor-alpha. Humira arrived in 2002.

These drugs have been especially helpful for autoimmune conditions like rheumatoid arthritis. When traditional medications (DMARDs or disease-modifying anti-rheumatic drugs) don’t do the job, doctors often turn to the TNF blockers.

Sarah in the United Kingdom shares this experience with Humira:

“I’ve had rheumatoid arthritis [RA] for nine years. It’s been incredibly painful. I write for a living so I need my hands to function. I’ve managed to hold down a job even though during the worst flares my hands were bent and looked like claws.

“Two years ago numerous medications had done nothing to relieve the RA. After 10 months on prednisolone, which worked for RA, but caused all sorts of other horror, I started on Humira (adalimumab). It’s completely changed my life. 99% of the time you’d never even know I had RA. Flares are practically unheard of. My hands look completely normal and no longer like claws. Even the fatigue has pretty much abated. And I’ve suffered absolutely no side effects.

“All in all, for me, it’s been a miracle cure. I know the US medical system is poles apart from the UK and that Humira is very expensive there. It gave me my life back.”

Not surprisingly, such stories have stoked sales of drugs like Humira. That is why these are billion-dollar bonanzas for the drug companies. But not everyone experiences such success without complications.

Humira Side Effects:

The first thing you discover when you look at the official prescribing information for Humira (adalimumab) is a black box titled:

WARNING: SERIOUS INFECTIONS AND MALIGNANCY

“Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death.”

Doctors are warned about “reactivation of latent TB” and “invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis.” These are not easy infections to overcome. In addition, the black box warning lists

“bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.”

Physicians are encouraged to “monitor patients closely for the development of signs and symptoms of infection during and after treatment with HUMIRA…”

A systematic review published in Expert Opinion on Drug Safety (Dec., 2016) concluded that:

“Our study encompassed data from 71 randomized controlled trials involving 22,760 participants and seven open label extension studies with 2,236 participants. Quantitative synthesis of the available data found statistically significant increases in the occurrence of any infections (20%), serious infections (40%), and tuberculosis (250%) associated with anti-TNF drug use, while the data for opportunistic infections were scarce.”

MALIGNANCY (from the FDA’s black box warning)

“Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including HUMIRA.”

Despite these ominous FDA-mandated warnings, the science linking TNF blockers to cancer remains controversial. One overview (Expert Opinion on Drug Safety, Dec. 2016) concluded:

“There was no evidence of an association between anti-TNF agents and cancer risk…We found evidence of selective outcome reporting or publication bias suggesting that the pooled effect estimate for cancer may have been overestimated.”

It remains to be seen whether the risk of lymphoma or other malignancies will show up in coming years as people have longer exposures to these TNF-inhibiting drugs.

Other Humira Side Effects:

  • Injection Site Reactions: because these drugs are delivered by shot, the complications in that area include redness, itching, pain, swelling and/or bleeding.
  • Serious Infections: pneumonia, septic arthritis, prosthetic and post-surgical infections, cellulitis, diverticulitis and pyelonephritis.
  • Liver enzyme elevations: liver damage
  • Upper Respiratory tract infections: sinusitis, flu-like symptoms
  • Digestive tract distress: nausea, stomach pain
  • Blood lipid changes: elevations in blood cholesterol
  • Headache
  • Rash
  • Back pain, pain in other extremities
  • Urinary tract infections
  • High blood pressure
  • Bone pain, muscle cramps, tendon disorders
  • Blood in the urine
  • Cancers: lymphoma, leukemias, skin cancer
  • Severe allergic reactions (anaphylaxis)
  • Heart failure, irregular heart rhythms
  • Autoimmune disorders (lupus-like syndrome, sarcoidosis)

Stories from Readers about Humira Side Effects:

A long list of Humira side effects is virtually meaningless to health professionals and patients alike. That’s because most people zone out after the first few words. They assume that none of those nasty complications could possibly apply to them. Here are some real-world experiences from visitors to this website:

Muddy in Alabama writes:

“I have had two shots of Humira every other week. I have been so sick that I was in the emergency room. All they could say was it was due to the Humira. I just wondered what damage it has done to my body? I am more sick now than with RA. No more Humira for me.”

Deloris shared this reaction after various biologics:

“I was diagnosed with RA two and half years ago. The moderate pain and joint destruction have remained the same throughout that time. I’ve taken methotrexate and prednisone since the onset, and my rheumatologist has tried many biologics to get my disease under control. The first was Cimzia.

“After only 3 doses, I stopped it due to sudden and severe muscle pain. TNF blockers are not to be given to people with MS, which I don’t have. However, I have permanent muscle and nerve damage from taking simvastatin, a cholesterol-lowering drug. I have enough muscle pain already. I don’t need any new agony presented by a TNF blocker.”

Hillary in Florida adds this note of caution:

“I have been taking Enbrel since 1998 for RA. It did give me a better life, with less pain. I was told of the risks, but when you have severe pain, you’ll deal with it.

“Forward to 2015. After a routine mammogram and further tests, I was diagnosed with CLL, Chronic Lymphocytic Leukemia. What a shock. But the doctor said it is a slow cancer, with no real cure. So treatment is ‘watch & wait.’ I have no symptoms and refused to stop Enbrel.

“I have also had a major issue with wound healing after a TAR revision in 2015. This could be due to Enbrel and/or CLL.”

“It’s a terrible position to be in. Without Enbrel, I’d be in severe pain. But now I have CLL and healing issues.”

Cathy in North Carolina shared this infection reaction:

“I have been on Remicade for two years for ulcerative colitis (UC). I try to avoid being around people who are sick. I have had two colds that evolved into double ear infections and had to go on antibiotics each time.

“If I get sick, it takes about four weeks to get over. Because I had breast cancer 12 years ago I still see a medical oncologist. She and I talk about the lymphoma risk. I have had UC for 30 years and feel fortunate to not have had to go on more aggressive therapy until now.”

Kay had to take prednisone to overcome Humira side effects:

“In 2015 I was hospitalized for three days following a terrible reaction to Humira. I received IV prednisone over those three days which eliminated the spinal and brain inflammation caused by the Humira.”

Bob had a terrible skin rash from a TNF blocker:

“I took my first Humira shot and one week later I woke up with whole body rash. This rash progressed on me for two days. It itched and burned and it made its way on to my face giving me a butterfly rash. The slightest amount of sun was burning like I had a bad sunburn. I went to the ER at 1:30 am and they didn’t know what to do so they told me to take Benadryl. Then they sent me home.

“I went to an urgent care facility and the doctor there gave me prednisone to help with the rash. It’s a week later and the rash has cleared some but I still have it. I felt all alone during this time. When you watch you body being attacked by a foreign substance it makes you really evaluate your reasons for subjecting yourself to such a risk.

“I will never ever take a drug like this again. Since this has happened I am trying to share my story because this can happen to anyone. I have read a lot of bad stories with this since my little ordeal and don’t think you’re immune to these same issues.”

Humira Drug Interactions:

First, we cannot list all the potential drug interactions with Humira. The list is just too long. Please make sure your health care providers know ALL the medicines you are taking so they can double check to make sure you are not getting into trouble.

Live vaccines are a potential problem. Before getting vaccine against shingles or other live vaccines, ask if there could be a serious problem!

Other biologicals (monoclonal antibodies with “mab” in the generic name. Such drugs may increase the risk of serious infections.

Antidepressant bupropion (Wellbutrin) may not work as well with Humira on board.

Carbamazepine (Tegretol) may not work as well to control seizures.

Statins (some cholesterol-lowering drugs like atorvastatin, fluvastatin or simvastatin may not work as well as expected)

This is just a partial list of drug interactions. Please double-check with your provider to make sure you are not getting into trouble with other medicines you take. Ask the physician, nurse practitioner or PA to use the drug-interaction checker on the computer and notify you if there are any worrisome combinations.

Want to read more about TNF blockers? Here is a link to an article we wrote about this class of medications.

Share your own Humira story below in the comment section.

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  1. Christy
    Indiana
    Reply

    Hi, I have been taking Humira for a year as of August. At first I thought it might be working, but then I started getting sick with constipation, vomiting, sweats. I have been told these are the side effects of the Humira. Before I took Humira I took Imuran for a few months and had to stop. It made me feel even worse. I’ve used all my sick and vacation days due to feeling like crude. I meet with my GI next week, and I am going to tell her I don’t want to be on it anymore. I’ve found another dr that thinks she can help me in more natural ways. Fingers crossed!

  2. Adah
    Sarasota, FL
    Reply

    I have Hidradenitis Suppurativa (HS). While, it’s unfortunate that Humira has not been a good choice for some, it has changed my life! I would not be as active as I am today. It’s granted me opportunities to be healthier, active, confident and motivated instead of confined and embarrassed by my condition. I understand the hype from the drug companies and the objective of what may drive them but please know that there are individuals who benefit from these medications in ways you may not understand!

  3. Danielle
    Virginia
    Reply

    We believe my daughter got methemoglobinemia from taking Humera for her Crohns. It’s been a living nightmare this past year.

  4. Kim
    Reply

    I was on Humira for approx. 6 years, to treat my Crohn’s disease. It was of moderate help to my Crohn’s, but I started to develop symptoms of what I thought was multiple sclerosis. Weakness and numbness in my arms and legs, which affected my walking and my manual dexterity. Only then did I see that Humira lists neurological disorders as a possible side effect.

    My GI doctor agreed that I should discontinue it, adding that another patient had developed leukemia while taking it. My symptoms went away after stopping it, thank goodness, and I’m on Apriso now, which has much less severe side effects, and is just as effective in my case.

    I know Humira helps many patients a great deal, but it scares me, and I now have a huge skepticism of powerful drugs and their equally powerful side effects. That’s why People’s Pharmacy and its emphasis on healthy living and safer alternatives is so important.

  5. Judy
    Nv
    Reply

    My son was diagnosed with Crohn’s Disease, had a fistula which doctors tried to treat with antibiotics but ended in disaster when he developed Septicemia from contaminated drain tube with Mercer.

    He managed to survive and they took out the affected intestine but then after several weeks his specialist wanted him to take Humira to keep the Crohn’s in check. As a retired nurse, I was skeptical considering he had such a severe infection, numerous MRI & radiation exposures predisposing him to cancer; knowing Humira contraindications would be infection; lymphoma risk.

    His doctor however told him he would not be his doctor if he did not take the med so reluctantly my son took it. Now a year later it appears he has Lymphoma – has not has total work up for it yet but most likely they will want to bombard him with chemotherapy.

    He is a single parent and can’t imagine how devastated his daughter will be if anything happens to him so I am wondering if there is anyone out there that has had success with alternate therapies for Crohn’s and Lymphoma.

    I grew up around Native American culture that used natural healing methods and would like to find a good Naturepath or Practitioner knowledgeable in these 2 disorders.

  6. Janet
    MD
    Reply

    Glenn Frye from The Eagles was on this for many years for RA. He developed UC and ended up in the hospital to have a good portion of his intestines removed. He developed pneumonia, immune system so suppressed that he couldn’t fight it off. So in essence, this drug was the beginning of the end for him.

  7. Barbara
    Albany, NY
    Reply

    I was diagnosed (wrongly, I might add) with Ankylosing Spondylosis. Went on Methotrexate and for 2-3 months. It was fine for about that time, until one morning I woke up with blood on my pillow. I had sores in my mouth to the point I couldn’t eat. But before the sores, I had the worst case of pneumonia I’ve ever had in my life!! I almost died.

    I screamed in pain every time I coughed. Went to dr.-no help. Took me off Methotrexate and said (after the horrible pneumonia), “Now we’ll try Humira.” I replied “No, WE won’t” and I walked out of the office. I decided that I needed my immune system. I feel bad for the people who don’t have choices, but I will tell you that Humira is stuff to be left alone. Now I take Fish Oil, Primrose Oil and Cat’s Claw. It’s helping me alot. I will try anything natural now and I will NOT go back to that poison!!

  8. Phil W.
    North Carolina
    Reply

    I was diagnosed with Rheumatoid Arthritis in 2015 after 18 months and 10 doctors. I finally got to a Rheumatologist who is caring for me now. I was on Methotrexate for the first year and it did not lower my inflammation or pain.

    My Dr. recommended Remicade infusions and I began them in April, 2017. The pain relief was almost instant. I have had 3 infusions and will begin maintenance (every two months) at the end of July.

    I still take Methotrexate weekly. Working with my Rheumatologist and Primary Care Physician, the goal is to increase the time between infusions and lower my Methotrexate dosage. I have regular blood work done on a regular basis. I have had no side effects.

    I know the risks and have read the side effects but at this point I feel like the benefits outweigh the risks. It would be nice to read some positive news on treatments once in awhile instead of having to live with terror every time you take a prescription medicine.

  9. Anne
    Chicago
    Reply

    I have Osteo-arthritis. Rather than taking drugs, I went to the book, “Healing With Whole Foods”, by Paul Pitchford. Since arthritis is an auto-immune disease, it recommends foods that are good for it and lists many foods to avoid. At the end of that, he mentioned that many people don’t find relief until they give up dairy. Since starting that and giving up refined sugar, my life seems to be arthritis free. The occasional pizza with cheese seems to be fine.

    Heavy amounts of sugary foods over a short time period, seeems to bring it back. I missed my easy noon time yogurt in the beginning –went back to it for a week and the arthritis came back also. Now I only use goat milk and goat milk yogurt, and occasionally sheep milk yogurt.

  10. wilber
    Reply

    Anecdotal reports of side effects are compelling but to be fair and, most of all, to be scientific and rational you should provide the best evidence of the the incidence of these side effects. I am surprised that you who present yourselves as representing the “people” would fail to do this most elementary task.

    • Deloris
      Reply

      Wilber: This would be the pharmaceutical companies’ take on the matter, defending their products with statistics and randomized control trials. Many of us users had listened to this spiel only to suffer — sometimes permanently — from quirky, unexpected side effects, often dismissed my our prescribing physicians. As treatment with multiple prescription drugs becomes more complicated and dangerous, we MUST warn others of our experiences, and the People’s Pharmacy gives us that forum quite effectively.

    • Joe Graedon
      Reply

      Hello Wilbur,

      Thank you for pointing out that it is important to be scientific. We completely agree. It is, however, sometimes hard to ascertain the long-term complications of medications.

      When the pharmaceutical industry performs clinical trials they are quite good at determining efficacy compared to placebo. That is the way they seek FDA approval. We have learned over the years that many adverse reactions are not discovered during those RCTs (randomized clinical trials). It can take years for them to show up. Case in point: the diabetes complication associated with statins.

      Here are the stats you requested:
      Upper respiratory tract infection: 17%
      Sinusitis: 11%
      Flu syndrome: 7%
      Nausea: 9%
      Abdominal pain: 7%
      Lab test abnormalities: 8%
      High cholesterol: 6%
      Liver enzyme elevation: 3%
      Headache: 12%
      Rash: 12%
      Accidental injury: 10%
      Injection site reaction: 8%
      Back pain: 6%
      Urinary tract infection: 8%
      High blood pressure: 5%

      The FDA does not provide percentages for other adverse reactions.

      One final note. As you point out, anecdotes are not scientific. But drug companies bombard the public with TV commercials that frequently feature actors having a wonderful time. They create a compelling story of great success with drug X or Y. When it comes time for the scary side effects an announcer runs through the long list quickly as people continue to have what appears to be a good time, even when complications like cancer are mentioned.
      Want to see what we are talking about? Here is a link to a commercial. Please note that the manufacturer does not provide statistics on effectiveness:
      https://www.youtube.com/watch?v=y5co4wtHaGo

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