Rheumatoid Arthritis Drugs Linked To Increased Infection Risks, Other Side Effects: Report

  • Written by: Irvin Jackson

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A new analysis of adverse event reports submitted to the FDA suggests that users of rheumatoid arthritis drugs, such as Enbrel, Humira, and Remicade, may be more likely to experience a serious infection. 

Hundreds of incidents involving tuberculosis, sepsis, and even herpes have been linked to all types of rheumatoid arthritis drugs, according to a new report by

The group examined adverse event reports submitted to the FDA involving tumor necrosis factor (TNF) blockers, including Enbrel, Humira, Remicade, Cimzia and Simponi, as well as non-TNF drugs, such as Actemra, Arava, Imuran, Orencia, Rituxan, and Xeljanz. The findings suggest that the drugs may lower patients’ resistance to infections, providing a potential safety signal.

Rheumatoid arthritis is an autoimmune disorder that causes inflammation of the joints. It affects about 1% of the population. Most drugs that are used to treat the condition suppress the autoimmune system to some degree. The ailment costs the global health market $14 billion annually.

Both TNF Alphas and non-TNF drugs showed increased risks in upper respiratory tract infections, bronchitis, nasopharyngitis, candida infections and herpes viral infections, though the rates varied from drug to drug and some did not show any increases in various ailments.

Out of all the drugs tested, only Orencia and Xeljanz did not show increased risks for tuberculosis. Remicade was the drug most linked to TB, with more than 1,600 reports.

The non-TNF drugs showed elevated reporting of anemia and pancytopenia, and sepsis and liver problems appeared to also be more common in those types of drugs.

In addition, a deadly brain infection, known as progressive multifocal leukoencephalopathy (PML), was limited exclusively to the non-TNF drugs Rituxan, Imuran, and Arava.

TNF-alpha drugs had far and away the most adverse event reports, but the drugs are much more widely used than their non-TNF counterparts.

According to the report, Enbrel had the most adverse events reported where it was the primary suspect drug. Since it was approved in 1998, the drug has been linked to 278,283 adverse event reports. That was followed by Humira, approved in December 2002, with 229,853 adverse event reports. No other drugs came close.

A number of other studies have linked TNF-alpha drugs with increased risks of cancer as well.

The medications TNF alpha drugs are blockbuster treatments, with Humira alone generating sales of $6.5 billion in 2010.

In September 2008, the FDA issued a warning to health care professionals that TNF blockers carried the risk of fungal infections, including histoplasmosis, blastomycosis and coccidioidmycosis. Some of those infections could be life-threatening, the agency warned.

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  1. Courtney Reply

    My grandfather died on July 4, 2015 because of Xeljanz. He developed a bad infection. couldn’t fight it, and died as a result.

  2. Christine Reply

    My husband died from multi-organ failure, caused by sepsis, apparently due to taking Xeljanz for 2.5 months.
    He died July 27, 2015

  3. Jana Reply

    I was told Embrel wasn’t working for me anymore, so my doctor asked me to try Orencia…had my shot on Tuesday ( 8/1815 ) an hour later…I was driving home – my feet started itching then my hands – I thought I had gotten into something…my hands turned blood red and starting burning and itching – it was maddening. I thought – I just need to get some Benadryl….so, I saw a CVS Pharmacy and pulled in…went to the pharmacy – showed them my hands…they thought the benadryl cream would help…it didn’t and by this time my chest, throat and face was turning bright red too. They asked me if I was Ok…I said No…my throat had started closing up and my tongue was swollen too…they called 911 and I was rushed to the ER IMMEDIATELY…they gave me a shot of Epinephrine and I started feeling better…the itching finally stopped. Scared me to death. I had never had a reaction like that before… I feel lucky I didn’t have a wreck while I was driving. God was really watching over me. There doesn’t seem to be ANY drugs for RA that don’t have “deadly” side-effects. I don’t want to go through that EVER AGAIN!

  4. Joseph Reply

    My wife died of multi-organ failure due to sepsis, 5 days after taking Actemra. She died on 1-23-2012.

  5. Rebecca Reply

    I was on Imuran for 2 years, it never fully worked and then I was on Actemra injections for 14 months. All the while I kept getting sicker with cold infections, bronchitis, pnuemonia, etc. Finally…I develops pnuemonia and kept it from October TILL February of the following year. After a 30 day hospital stay, I ant home with collapsed lungs, lung infections and heart & pulmonary damage. They stopped the Actemera immediately and it’s been non-stop hospitals still in/out and no RA meds for 10 months. Started Orencia infusions this past January. But since October I’ve had to have IVIG’s to try to raise my body’s immune system, IVIG #11 just happened and I still haven’t! Actemra made me Septis, diminished my lungs and gave me Hypogammaglobulinemia. Had to get a port and must nebulize 5 times a day! STILL…since September 2014.

  6. Irene Reply

    Remicade infusions had me break out with shingles every time.
    Jana-if you live in a state that had medical CBD it’s worth checking out. The research I’ve done makes me wonder why the doctors and government won’t let us use it. Guess it would hurt pharmaceuticals too much. I’ve done so much research and the benefits of CBD is endless! No bad side effects and it helps!!!

  7. meg Reply

    I had 5 infusions of orencia between mid Aug and Nov. Major damage to my digestive system and caused angina-so far 9 months to recover and still not 100%. Is RA pain easier than risking other new problems??

  8. Robert Reply

    My wife took Orencia. She developed sepsis, multi-organ failure, and aspergillosis. She died in August, 2007, after nearly a month on a ventilator.

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