Actemra
facts &
statistics

STAT REPORT

500,000

reports of side effects

FDA

1,130

died while taking

anitipated

1000’s

of lawsuits

Actemra

Actemra is prescribed to treat moderate-to-severe rheumatoid arthritis and giant cell arteritis in adults and polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis in children. These inflammatory diseases are associated with chronic pain and limitations on mobility. It’s estimated 760,000 patients are prescribed Actemra worldwide, with global annual sales totaling $1.7 billion.

Some rheumatoid arthritis sufferers were excited when Actemra hit the U.S. market in 2010, following regulatory approval from the U.S. Food & Drug Administration. Genentech, a member of the Roche Group and maker of Actemra (known generically as tocilizumab), promised it would “transform expectations” for both doctors and patients. Even better, Actemra didn’t come with any warning of heart attacks, strokes and other complications, as competing drugs did. It was seemingly safer.

Today, there is a growing body of evidence to the contrary. Our best Actemra injury attorneys in Weber County at The Esparza Law Group know that since its release, Actemra has been linked to serious health complications, hospitalizations and death.

Of course, many drugs have known side effects, some of them quite serious. Among those listed by Actemra: Infections, stomach tears, changes in blood test results, increased risk of certain cancers, hepatitis B infections, serious allergic reactions, nervous system problems and upper respiratory tract infections. These are awful. But in general, because patients are warned of these side effects, they assume that risk if they choose to take it.

However, the issue is there are some also some patient-reported risks with taking Actemera for which there were no apparent warnings.

Some of the complications reported by patients include:

  • Acute pancreatitis
  • Heart attack
  • Heart failure
  • Stroke
  • Interstitial lung disease (sometimes fatal scarring of lung tissue)

If you have suffered one of these conditions while taking Actemra, you may have grounds for a product liability lawsuit. Even if your injury is an outlier to this list, it can be worthwhile to discuss your legal options with an injury attorney in a free initial consultation.

What is Rheumatoid Arthritis?

Approximately 1.5 million people in the U.S. suffer from rheumatoid arthritis, which most commonly affects women between the ages of 30 and 60, per the Arthritis Foundation.

According to the Mayo Clinic, rheumatoid arthritis is an inflammatory autoimmune disorder that is chronic and affects more than just joints. It can cause damage to the heart, lungs, blood vessels, skin, nerve tissue, kidneys, salivary glands and eyes.  It occurs when your immune system starts attacking your own body tissue, affecting primarily the lining of the joints, resulting in painful swelling and sometimes the erosion of bone.

About 40 percent of those with rheumatoid arthritis also suffer symptoms that don’t involve joints.

People diagnosed with this condition often grapple with “flares, “which is when there is an uptick of the signs and symptoms of the disease, followed by periods of seeming remission. Eventually after enduring this cycle time and again, joints can be caused to shift and deform.

Although it’s known there is a genetic component to rheumatoid arthritis, it’s believed one’s genes make them more susceptible to environmental triggers, though the latter have not been identified.

What is Actemra?

As noted by the American College of Rheumatology, tocilizumab (Actemra) is comprised of proteins that are designed to have an impact on the immune system.

Specifically, Actemra blocks the IL-6 inflammatory protein, which in turn is supposed to help with swelling, joint pain and other symptoms that result from inflammation.

Actemra doesn’t exist in pill form. It’s either an intravenous infusion every month or a subcutaneous injection once every week or two weeks. Sometimes, Actemra is prescribed on its own, but it is also sometimes prescribed with other medications.

STAT Investigation of Actemra

Amid rumblings that Actemra was associated with higher rates of stroke and heart attack, independent news media provider STAT (owned by the Boston Globe with headquarters in Washington, New York, Cleveland, Atlanta, San Francisco and Los Angeles) launched an investigation into those reports.

In 2017, STAT released its report, which found hundreds of patients taking Actemra died from heart attacks, heart failure and lung complications that weren’t reported on Genentech’s label for the drug. The news agency analyzed some 500,000 reports of side effects made to the FDA, and found “clear evidence” that the risk of these serious complications were as high or higher for patients who took Actemra as for those who take other drugs. The difference is most of the manufacturers of those other medications have installed warning labels indicating the risk. Actemra has not.

The FDA has reportedly been in receipt of nearly 1,130 reports of individuals who died while taking Actemra, but the agency has yet to investigate whether Actemra was a contributing factor in those deaths or whether it was coincidental. Although the FDA doesn’t verify the side effects that are reported, the documents the agency received were reviewed by STAT, and there were indications there by doctors that Actemra was the only explanation for fatal incidents, including deadly brain bleeds, pancreatitis and heart attacks and strokes.

Despite this evidence, neither the manufacturer nor the FDA has taken action to update Actemra’s label. Numerous experts consulted by STAT on the data recommended an immediate update to the label for warnings of pancreatitis and heart failure. Evidence of interstitial lung diseases, strokes and heart attacks was tenuous, but should be further investigated, they said.

Doctors interviewed by STAT say that while the process of drug approval has become faster and more streamlined, the FDA has failed to improve its post-approval monitoring of these medications and their adverse side effects. This assertion appears supported in a 2016 report by the U.S. Government Accountability Office, which concluded the FDA doesn’t have access to readily accessible, reliable data that would be necessary for streamlined oversight to track truck safety and make sure companies are appropriately marketing these drugs, and not advertising them for off-label uses.

It’s anticipated that there could be hundreds if not thousands of lawsuits against Actemra’s manufacturer in the coming years.

Contact the Salt Lake City Actemra injury attorneys at the James Esparza Law Group by calling toll-free 800-745-4050.

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