Actemra (known generically as tocilizumab), a rheumatoid arthritis (RA) medication, may be associated with life-threatening side effects and may have caused hundreds of deaths, according to a new investigation published in STAT that has called Actemra's safety into question.

STAT's investigation analyzed more than 500,000 reports of side effects associated with rheumatoid arthritis drugs and "found clear evidence that the risks of heart attacks, strokes, heart failure, and other conditions were as high or higher for Actemra patients than for patients taking some competing drugs." STAT also found reports of other severe side effects such as interstitial lung disease and pancreatitis. Furthermore, the study found 1,128 deaths suffered by patients after taking Actemra have been reported to the Food and Drug Administration (FDA).

Other rheumatoid arthritis drugs such as Humira, Remicade and Enbrel warn of the risk of congestive heart failure. The Actemra label does not. Nor does Actemra warn of the risks of heart attacks, strokes, interstitial lung disease or pancreatitis. These conditions can cause serious injury and even death.

What is Actemra?

Actemra (Tocilizumab) is a monoclonal antibody drug developed by Genentech, a member of the Roche Group. When first approved in 2010, Actemra was hailed as a new option for rheumatoid arthritis patients whose condition had not responded to other RA drugs. It is approved for treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and most recently for giant cell arteritis. Patients can receive their medication either intravenously or by Actemra injection.

According to STAT, Actemra is used by more than 760,000 patients around the world and generated sales of around $1.7 billion in 2016. In addition to being approved to treat rheumatoid arthritis, Actemra has been prescribed off-label to treat other conditions.

Actemra side effects

Among the side effects reportedly linked to Actemra use:

  • Heart attack
  • Stroke
  • Heart failure
  • Interstitial lung disease
  • Pancreatitis

Other side effects that have reportedly been linked to Actemra:

  • Tremors
  • Tachycardia
  • Hair loss

If you are taking Actemra and suffer any of these side effects, seek medical attention immediately. Some side effects are serious and can cause long-term damage and even death.

If you have suffered side effects of Actemra, contact an attorney to discuss your legal options. You may be eligible to file a lawsuit against Genentech.

What do studies say about Actemra side effects?

A study conducted for STAT by Advera Health Analytics found hundreds of reports to the FDA of serious side effects between 2010 and 2016 linked to Actemra and similar medications. Among those side effects:

  • Heart attack (410 cases)
  • Stroke (359)
  • Heart Failure (224)
  • Interstitial lung disease (222)
  • Pancreatitis (132)

Although Actemra had fewer reports of side effects than similar drugs Remicade or Humira, STAT noted that the higher numbers could be because Remicade and Humira are used by a much larger number of patients and because patients on those drugs are warned about the risks, meaning they may be more likely to watch for and report adverse reactions.

Reporting of adverse reactions is also generally low because reporting is voluntary, not mandatory. This makes it likely the actual number of side effects-including Actemra heart attack, stroke and heart failure-could be much higher than those reported to <i>STAT</i>. In fact, the numbers presented could be as low as one-tenth the actual number of Actemra adverse events.

The FDA reportedly requested studies be conducted after the drug was approved for the market. Of those, one study found Actemra was associated with 24 cardiac disorders, 27 cardiac disorders plus stroke, and 8 fatal and nonfatal myocardial infarctions and strokes. A second study found Actemra was linked to 36 cardiovascular deaths, 64 all-cause mortalities, and 90 major adverse cardiovascular events. (Source: https://www.documentcloud.org/documents/3766911-The-Actemra-Documents.html)

Are there risks of Actemra deaths?

Actemra heart attack and other side effects have the potential to be fatal. Studies conducted after Actemra was approved for the market found the medication was linked to fatal and nonfatal cardiovascular disorders, including cardiovascular death. (Source: https://www.documentcloud.org/documents/3766911-The-Actemra-Documents.html)

Data from the FDA found that of 132 patients who reported pancreatitis after taking Actemra, 26 died. The same study found 55 reports of fatal and non-fatal myocardial infarction and stroke. (Source: https://www.statnews.com/2017/06/05/actemra-rheumatoid-arthritis-fda/)

Do similar drugs have similar side effects?

Drugs that are similar to Actemra include Remicade, Humira, and Enbrel. Studies have found that at best Actemra has similar rates of side effects as the other three drugs. Despite having similar side effects as the other drugs, Actemra is the only drug in the group that does not warn about any of the concerning side effects.

Some studies have shown that Actemra has a higher rate of side effects when compared with competing drugs. One study that compared Actemra head-to-head with Enbrel found the rate of Actemra stroke and heart failure was 1.5 times higher than with Enbrel. (Source: https://www.statnews.com/2017/06/05/actemra-rheumatoid-arthritis-fda/ and http://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/)

Should young patients be concerned about possible side effects?

According to the STAT report, young patients are at risk of serious side effects. The article shares the story of Alicia Airs, a 40-year-old who took tocilizumab for rheumatoid arthritis but suffered palpitations repeatedly after receiving an Actemra infusion. Meanwhile, a 25-year-old student named Alejandra Calzadillas reported suffering memory lapses and brain fog after starting her Actemra treatment.

Patients of any age who take the medication should be aware of side effects of Actemra.

What does the U.S. Food and Drug Administration (FDA) say about Actemra?

The FDA has so far not issued any warnings or Safety Communications since tocilizumab was approved. Although concerns have been raised about an increased risk of Actemra acute pancreatitis and other serious side effects, the FDA has remained silent about the drug.
In a written statement to STAT, a spokesperson said the FDA, "continually monitors postmarketing safety of approved drug products and remains committed to informing the public in a timely manner when the FDA identifies safety issues." (Source: https://www.statnews.com/2017/06/05/actemra-rheumatoid-arthritis-fda/)

Does the label warn about any possible Actemra adverse reactions?

Actemra's warning label mentions a risk of serious infections, including tuberculosis, bacterial, invasive fungal, viral, and other infections. It does not warn about a risk of Actemra heart attack, brain bleed, interstitial lung disease or pancreatitis.

Drug companies like Genentech-maker of Actemra-have a duty to patients to warn them of any side effects so patients can make an informed decision as to whether the risks outweigh the benefits. Failure to do so forces doctors and patients to contend with a lack of accurate Actemra prescribing information when making medication choices. When companies fail to warn about the risk of side effects, patients may be eligible to file a lawsuit against those companies for failure to warn, especially if the drug maker knew or should reasonably have known about the risk of adverse events.

Actemra Attorneys

Critics argue Genentech misled patients into believing Actemra was safer than other, similar drugs on the market. Furthermore, they allege the company negligently marketed the drug knowing there was a risk of serious side effects, including heart attack, stroke and pancreatitis. Doing so put the lives of patients at risk.

Free Consultation: Contact Cutter Law Today

If you or a loved suffered a serious side effect such as heart attack, stroke, heart failure, interstitial lung disease, pancreatitis or death after taking Actemra, you may be eligible to file an Actemra lawsuit.

Don't delay. Your rights could be affected by your state's statute of limitations.

Please give us a call toll-free at 888-285-3333 or request a free consultation online.