Not Accepting Cases

Actemra Side Effects

Actemra (tocilizumab) is an injectable immunosuppressant drug primarily used to treat rheumatoid arthritis (RA). Its side effects include runny nose, headache and high blood pressure. Though rare, the drug can also cause deadly infections, allergic reactions and gastrointestinal perforation. Unlike competitor RA drugs, Actemra’s label does not warn of other serious side effects like heart failure and stroke, though research shows these adverse events have occurred.

Side effects listed in Actemra’s label range from injection site irritation and cold-like symptoms to life-threatening allergic reactions and gastrointestinal (GI) perforation. The injectable rheumatoid arthritis drug also carries a black box warning about a risk of serious, sometimes fatal infections.

Research and analyses of the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS) suggests there may be other potentially serious risks not included in the label, such as cardiovascular risks, pancreatitis and interstitial lung disease.

An investigation has shown these sometimes deadly side effects occurred at the same or higher rates in patients taking Actemra (tocilizumab) compared to those taking other RA drugs like Humira, Enbrel and Remicade.

Common Side Effects

Common side effects of Actemra are usually not serious, but patients should speak with their doctor if these side effects persist or become bothersome. The most common side effects reported during clinical trials affected 5 percent or more of the people taking part.

Most common side effects reported in clinical trials:
  • Runny or stuffy nose, sinus pain or sore throat
  • Common cold
  • Headache or dizziness
  • Increased/high blood pressure
  • Abnormal liver function tests
  • Pain, swelling, burning, itching or irritation where the injection was given

Manufacturer Genentech warns doctors to use platelet counts and liver function tests to monitor patients taking the drug because sudden changes in these levels can indicate serious health complications.

Gastrointestinal Perforation

Some patients who took Actemra in clinical trials reported gastrointestinal perforation, which is a hole in the wall of the stomach or intestines. Many of these patients suffered inflammation or infection of pouches in the colon known as diverticulitis.

The drug’s label warns that individuals at an increased risk for GI perforation should be cautious when taking the medication and should report any new abdominal symptoms to their doctor.

Gastrointestinal Perforation Illustration
Expand
Gastrointestinal perforation — also known as ruptured bowel — is a hole in the wall of the gastrointestinal tract.

Medical data company eHealthMe publishes and routinely updates an analysis of FDA reports involving Actemra and GI perforation. From when the FDA first approved the drug in 2010 through November 2018, a total of 27,666 people had reported side effects when taking the drug, according to the analysis. In all, 0.76 percent had intestinal perforation.

Of the 210 people who reported GI perforation, about 32 percent experienced the side effect within one to six months of starting treatment. Another 22 percent of affected patients suffered from the condition within one to two years of first taking the drug, while 19 percent reported having the issue within two to five years of their first dose.

Women were almost four times more likely to have GI perforation as a side effect compared to men, according to the analysis. More than 62 percent of people affected by the condition were aged 60 and older. Diverticulitis was also present in almost 16 percent of those who had GI perforation.

Severe and Life-Threatening Infections and Allergic Reactions

Genentech added fatal anaphylaxis to the drug’s label in 2011 after two people died of severe, life-threatening allergic reaction. According to the label, an allergic reaction to tocilizumab can happen even when patients have not previously reacted to the drug.

Allergic reaction, urticaria.
Expand
During clinical trials, some participants had to quit taking Actemra because they developed a skin rash with red itchy bumps or hives known as urticaria.

Not all allergic reactions to tocilizumab are deadly, but some patients in clinical trials had to stop taking the drug because of allergic reactions. These reactions included erythema (redness of the skin) and urticaria (skin rash with red itchy bumps or hives).

Research has also found tocilizumab can increase a person’s likelihood of getting an infection or it can make current infections worse.

Some people taking the medication have been hospitalized or died from infections, including tuberculosis, and bacterial and viral infections. Reports also identify fungal infections like candidiasis, aspergillosis and pneumocystis.

Hepatitis B infection may occur in people who take Actemra and carry the virus in their blood. Doctors may order blood tests before and during treatment. It’s important to tell your doctor if you feel tired, lose your appetite or have clay-colored bowel movements. Other symptoms to watch for include vomiting, chills, dark urine, stomach discomfort, skin rash, fever, muscle aches, and yellow skin or eyes.

The drug’s label advises patients to avoid live vaccines because there has not been enough research to determine if live vaccines could lead to infection while on the drug. Because of the way tocilizumab works, it may interfere with how the immune system processes new vaccinations. The label recommends patients get up-to-date on all vaccines before starting treatment.

Cancers and Nervous System Disorders

People taking tocilizumab may be at an increased risk of certain cancers. Researchers observed these cancers in clinical trials. Actemra’s label warns patients to tell their doctor if they have “ever had any type of cancer” before starting treatment.

Tocilizumab is an immunosuppressive drug. These types of drugs “make the immune system less able to detect and destroy cancer cells or fight off infections that cause cancer,” according to the National Cancer Institute.

“[Immunosuppressive] drugs make the immune system less able to detect and destroy cancer cells or fight off infections that cause cancer.”

Source: National Cancer Institute

However, a 2016 study published in Rheumatic & Musculoskeletal Diseases Open found no increased malignancy rates among patients taking tocilizumab. Researchers looked at 4,009 patients being treated with the drug. They reported “malignancy types and rates were consistent with those expected” in rheumatoid arthritis patients.

The drug’s label also warns that multiple sclerosis has been diagnosed in people who take the drug – though it is rare. The medication’s potential effect on some nervous system disorders is unknown.

STAT Investigation Found Heart Failure, Heart Attack and Stroke Risks

In 2017, the medical news organization STAT examined a half million adverse event reports on rheumatoid arthritis drugs. Its investigation found “clear evidence” that patients who took Actemra had as high or higher risk of having a heart attack, stroke or heart failure compared to patients who took other arthritis medications.

The arthritis drugs Humira and Remicade list heart attack and heart failure as risks on their labels, while Humira also lists stroke. Actemra’s label does not warn about these risks.

Experts reviewed the data and concluded that the FDA should “immediately consider warnings for heart failure.” But as of November 2018, the federal agency had not yet required an update.

The STAT article quoted a transcript of a 2008 meeting of FDA scientific advisers. The meeting was to debate whether to recommend the FDA approve Actemra.

“I can foresee the possibility that in five years there’s another hearing like the one on Vioxx, where the cardiologists … say to us, what were you guys thinking when you approved this drug?” Dr. David Felson, Boston University rheumatologist and FDA scientific adviser said during the 2008 meeting.

“I can foresee the possibility that in five years there’s another hearing like he one on Vioxx, where the cardiologists … say to us, what were you guys thinking when you approved this drug?”

Source: Dr. David Felson, Boston University rheumatologist and FDA scientific adviser, as quoted in STAT in 2017

A study presented at the 2016 American College of Rheumatology Annual Meeting compared tocilizumab to another rheumatoid arthritis drug, etanercept — also known by the brand name Enbrel. The researchers found a 5 percent increase in relative risk of a major cardiovascular event for Actemra users compared to Enbrel users.

All 11 authors of the study disclosed financial connections to Roche, Genentech or both. Two of the researchers were employed by either Roche or Genentech.

Another 2017 study in the journal Arthritis and Rheumatology found that the medication may be causing cardiovascular conditions at similar rates — but not at increased rates — to other drugs that already carry a warning. Researchers at Brigham and Women’s Hospital in Boston along with Genentech staff researchers in San Francisco conducted the study.

An October 2018 eHealthMe analysis of FDA reports found about 48 percent of heart failures and nearly 26 percent of heart attacks that happened in patients taking Actemra occurred within one month of the first dose.

About 29 percent of strokes were reported within the first month, according to the analysis. The company also found that more than 2 percent of all adverse event reports associated with the drug were for heart attacks, heart failure or stroke.

Pancreatitis and Interstitial Lung Disease

As of Sept. 30, 2018, FAERS showed 107 cases of pancreatitis and 308 cases of interstitial lung disease reported in patients who used Actemra since 2010. This included a total of 60 deaths.

But the FDA points out that reports may not reflect an actual cause-and-effect relationship between the drug and the reported side effect. It stresses that the deaths may not be related to the medication.

An analysis from eHealthMe found pancreatitis affected 0.42 percent of the 27,666 Actemra users who reported side effects to the FDA between 2010 and mid-October 2018.

The analysis showed half of all pancreatitis cases developed in the first six months of starting Actemra. It also found women reported 70 percent of pancreatitis side effects.

Actemra Adverse Event Reports
About 70 percent of reports of pancreatitis and 72 percent of reports of interstitial lung disease involved women.

A November 2018 analysis from eHealthMe showed interstitial lung disease accounted for 1.65 percent of all Actemra adverse event reports to the FDA.

The analysis found nearly 58 percent of patients in the reports developed interstitial lung disease within the first six months of taking the drug. Women accounted for 72 percent of those reporting the condition.

Actemra’s drug label does not warn of either possible side effect. Related drugs Humira and Remicade both carry warnings for interstitial lung disease. Humira also lists pancreatitis as an adverse reaction identified during post-approval use.

Deaths Reported to the FDA

The FDA received reports on 1,128 people who died after taking tocilizumab, according to STAT.

Deaths associated with the medication occurred from stroke, heart attack, heart failure, pancreatitis, infection, bowel perforation, severe allergic reactions and other serious side effects.

The investigation suggested Actemra may not be more dangerous than other arthritis drugs on the market, but that it is being misrepresented as a safer alternative to drugs like Humira, Enbrel and Remicade.

These other drugs contain warnings on their labels for various fatal side effects, but Actemra’s drug label does not warn consumers or doctors of these risks. Lawyers are preparing to take legal action on behalf of people whose family members died while taking the medication.

Please seek the advice of a medical professional before making health care decisions.

Related Pages
Terry Turner
Written By Terry Turner Writer

Terry Turner has been writing articles and producing news broadcasts for more than 25 years. He covers FDA policy, proton pump inhibitors, and medical devices such as hernia mesh, IVC filters, and hip and knee implants. An Emmy-winning journalist, he has reported on health and medical policy issues before Congress, the FDA and other federal agencies. Some of his qualifications include:

  • American Medical Writers Association (AMWA) and The Alliance of Professional Health Advocates member
  • Centers for Disease Control and Prevention Health Literacy certificates
  • Original works published or cited in Washington Examiner, MedPage Today and The New York Times
  • Appeared as an expert panelist on hernia mesh lawsuits on the BBC
Edited By

26 Cited Research Articles

  1. National Cancer Institute. (2015, April 29). Immunosuppression. Retrieved from https://www.cancer.gov/about-cancer/causes-prevention/risk/immunosuppression
  2. Giles, J.T. et al. (2016, October 19). Comparative Cardiovascular Safety of Tocilizumab vs. Etanercept in Rheumatoid Arthritis: Results of a Randomized, Parallel-Group, Multicenter, Noninferiority, Phase 4 Clinical Trial. 2016 American College of Rheumatology/Association of Rheumatology Health Professionals. Retrieved from https://acrabstracts.org/abstract/comparative-cardiovascular-safety-of-tocilizumab-vs-etanercept-in-rheumatoid-arthritis-results-of-a-randomized-parallel-group-multicenter-noninferiority-phase-4-clinical-trial/
  3. U.S. Food and Drug Administration. (2018, September 12). Actemra Label. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s122,125472s031lbl.pdf
  4. Kim, S.C. et al. (2017, April 28). Cardiovascular Safety of Tocilizumab Versus Tumor Necrosis Factor Inhibitors in Patients with Rheumatoid Arthritis: A Multi-Database Cohort Study. Arthritis and Rheumatology. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/28245350
  5. Rupert-Roth, A. et al. (2016, May 10). Malignancy Rates in Patients with Rheumatoid Arthritis Treated with Tocilizumab. Rheumatic & Musculoskeletal Diseases. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4874056/
  6. Piller, C. (2017, June 5). Failure to warn: Hundreds died while taking an arthritis drug, but nobody alerted patients. STAT. Retrieved from  https://www.statnews.com/2017/06/05/actemra-rheumatoid-arthritis-fda/
  7. eHealthMe. (2018, October 18). Actemra and Pancreatitis – from FDA reports. Retrieved from  https://www.ehealthme.com/ds/actemra/pancreatitis/
  8. Medline Plus. (2017, September 28). Chronic pancreatitis. U.S. National Library of Medicine. NIH. Retrieved from  https://medlineplus.gov/ency/article/000221.htm
  9. Stanford Health Care. (n.d.). Symptoms of Interstitial Lung Disease (ILD). Stanford Medicine. Retrieved from  https://stanfordhealthcare.org/medical-conditions/chest-lungs-and-airways/interstitial-lung-disease/symptoms.html
  10. eHealthMe. (2018, November 5). Actemra and Interstitial lung disease – from FDA reports. Retrieved from  https://www.ehealthme.com/ds/actemra/interstitial-lung-disease/
  11. Medline Plus. (2018, May 17). Interstitial Lung Diseases. U.S. National Library of Medicine. NIH. Retrieved from  https://medlineplus.gov/interstitiallungdiseases.html
  12. Medline Plus. (2016, February 27). Peritonitis. U.S. National Library of Medicine. NIH. Retrieved from  https://medlineplus.gov/ency/article/001335.htm
  13. Medline Plus. (2016, October 12). Gastrointestinal perforation. U.S. National Library of Medicine. NIH. Retrieved from  https://medlineplus.gov/ency/article/000235.htm
  14. eHealthMe. (2018, July 10). Actemra and Intestinal perforation – from FDA reports. Retrieved from  https://www.ehealthme.com/ds/actemra/intestinal-perforation/
  15. National Stroke Association. (n.d.). Signs and Symptoms of Stroke. Retrieved from  http://www.stroke.org/understand-stroke/recognizing-stroke/signs-and-symptoms-stroke
  16. Centers for Disease Control and Prevention. (2015, August 5). Heart Attack Signs and Symptoms. Retrieved from  https://www.cdc.gov/heartdisease/signs_symptoms.htm
  17. eHealthMe. (2018, October 14). Actemra and Stroke – from FDA reports. Retrieved from  https://www.ehealthme.com/ds/actemra/stroke/
  18. eHealthMe. (2018, October 15). Actemra and Cardiac failure congestive – from FDA reports. Retrieved from  https://www.ehealthme.com/ds/actemra/cardiac-failure-congestive/
  19. eHealthMe. (2018, October 22). Actemra and Heart attack – from FDA reports. Retrieved from  https://www.ehealthme.com/ds/actemra/heart-attack/
  20. Genentech. (2018, May). Full Prescribing Information. Retrieved from https://www.gene.com/download/pdf/actemra_prescribing.pdf
  21. Genentech. (n.d.). Actemra Clinical Study Safety. Retrieved from  https://www.actemrahcp.com/ra/clinical-study-safety/clinical-study-safety.html
  22. Daily Med. (2018, May 25). Label: Actemra – tocilizumab injection, solution, concentrate; Actemra – tocilizumab injection, solution. U.S. National Library of Medicine. NIH. Retrieved from  https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13#S2.9
  23. Genentech. (n.d.). Treatment Method Options. Retrieved from  https://www.actemra.com/ra/taking-actemra/taking-actemra-treatment-options.html
  24. Genentech. (n.d.). How Actemra Is Believed To Work. Retrieved from  https://www.actemra.com/ra/consider-actemra/actemra-works-differently.html
  25. American Heart Association. (2017, May). Warning Signs of Heart Failure. Retrieved from  http://www.heart.org/HEARTORG/Conditions/HeartFailure/WarningSignsforHeartFailure/Warning-Signs-of-Heart-Failure_UCM_002045_Article.jsp#.W0zRvPZFyhc
  26. Hull, K.M. & Yim, S.K. (2012, September 10). Medical Review(s). Center for Drug Evaluation and Research. FDA. Retrieved from  https://www.accessdata.fda.gov/drugsatfda_docs/bla/2012/125276Orig1s049MedR.pdf
View All Sources
Who Am I Calling?

Calling this number connects you with Wilson and Peterson, LLP or one of its trusted legal partners. A law firm representative will review your case for free.

Wilson and Peterson, LLP funds Drugwatch because it supports the organization’s mission to keep people safe from dangerous drugs and medical devices.

(888) 645-1617