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
- 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.