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Recent research suggests that Actemra, a popular rheumatoid arthritis drug manufactured by Roche, may cause life-threatening complications:
A recent analysis of federal data suggests that Actemra has been linked to hundreds of patient deaths. Roche, however, has never warned the public about these potential risks.
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Rheumatoid arthritis drug Actemra has been linked to numerous life-threatening side effects, including heart failure, pancreatitis, stroke, heart attacks and interstitial lung disease. A new analysis of FDA adverse event reports has shown that, despite being advertised as a safer option, Actemra appears to cause severe complications at the same or higher rate as competitor products like Humira. Experts say Actemra may have caused hundreds of deaths, but the drug’s warning label makes no mention of its alleged risks.
Now, injured patients have begun to file personal injury lawsuits, accusing Actemra’s manufacturer, Swiss pharmaceutical giant Roche, of concealing the drug’s potential risks from the medical community and public. Guided by experienced pharmaceutical attorneys, thousands of current and former Actemra patients may be eligible to file lawsuits of their own, pursuing financial compensation for their medical expenses, lost wages and pain and suffering.
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Treating rheumatoid arthritis has presented a challenge to patients and doctors for decades, according to STAT. As a chronic autoimmune disorder, the long-term complications of rheumatoid arthritis are often mitigated through a regimen of aggressive pharmaceutical treatments.
While strong dosages of traditional non-steroidal anti-inflammatory drugs (aspirin, ibuprofen) may be enough to stop the disorder’s immediate symptoms, a class of more-powerful drugs, known as disease-modifying antirheumatic drugs, are usually necessary to prevent the long-term destruction of joint tissue, osteoporosis and permanent disability.
These “second-line” medications can be terrifyingly aggressive. Methotrexate, a common choice, is also used as a chemotherapy drug – and comes with all the severe complications that we normally associate with cancer treatment.
Rheumatoid arthritis patients often faced debilitating side effects from treatment, over and above the consequences of their autoimmune disorder. Severe cardiovascular complications and fatal lung diseases were common. Thus, the approval of Actemra in 2010 was heralded as a true medical “breakthrough,” one that could forever improve the prognosis for rheumatoid arthritis patients.
The drug’s active ingredient, tocilizumab, is the first chemical believed to interrupt the action of interleukin-6, a small protein secreted by white blood cells and responsible for triggering inflammatory responses. Even more promising, early clinical trials had shown that Actemra caused far fewer serious side effects when compared to competitor drugs like Humira and Enbrel. It can be administered either as a monthly intravenous infusion or in weekly injections beneath the skin.
Doctors got excited. A radical new treatment had been approved to help the more than 1.3 million Americans currently affected by rheumatoid arthritis – and it seemed to be much safer than other options. Actemra quickly grew in popularity, becoming a common monotherapy for rheumatoid arthritis. Today, the drug is Roche’s fifth-best selling pharmaceutical, according to Reuters, raking in around $833 million in revenue every year.
In response to successful clinical trials, the Food & Drug Administration has expanded Actemra’s approval to include the treatment of young patients diagnosed with juvenile idiopathic arthritis and those suffering from giant cell arteritis, an inflammatory disease of the arteries.
Roche, however, may have a big problem. While Actemra was advertised as a safer option for rheumatoid arthritis, thousands of clinical reports suggest that the drug may be just as dangerous as its popular competitors, including Humira and Remicade.
A new analysis of FDA adverse event reports has shown that Actemra patients develop interstitial lung disease, heart attack, stroke and heart failure at the same rate as those taking Humira or Remicade. The real difference? Humira and Remicade, along with many other rheumatoid arthritis drugs, clearly warn healthcare professionals and patients about these risks in their warning labels.
Actemra has no similar warnings.
Conducted by California-based pharmaceutical monitoring company Advera Health Analytics, a sweeping study of side effect reports sent to the Food & Drug Administration discovered “higher than expected” reports of several life-threatening complications:
Competitor drugs Humira and Remicade are known to cause the same side effects, but, as we’ve seen, the major difference is that their warning labels alert patients to many of these risks in plain terms. Actemra’s labeling, on the other hand, does not. As just one example, the rate of interstitial lung disease, in which lung function deteriorates over time due to scarring, was nearly identical for Actemra and Humira patients. Humira’s labeling materials bear prominent warnings about the disease, but the FDA-approved label for Actemra never mentions “interstitial lung disease” once.
The situation is similar, Advera Health Analytics found, for heart attack, stroke and heart failure. Humira and Remicade advertise clear warnings. Actemra doesn’t, despite being linked to a similar rate for these complications.
A number of recent long-term studies have found similar results. An analysis of insurance claims performed by researchers at Brigham and Women’s Hospital in Boston, for example, uncovered evidence that patients taking Actemra suffer heart attacks and strokes at the same rate as people on competitor drugs. Many of those other drugs, however, bear conspicuous warnings about cardiovascular complications. Actemra doesn’t.
The results of a randomized trial led by scientists at Columbia University were even more striking. Compared to patients taking Enbrel, people on Actemra experienced strokes or heart failure around 50% more often. Enbrel’s labeling warns doctors to avoid use in patients with pre-existing heart conditions; Actemra’s label, as by now you can guess, does not.
None of these study results, however, led to a labeling change.
The problem with Actemra is not so much that the drug may cause severe side effects. As we’ve seen, most aggressive rheumatoid arthritis medications do, too. The real issue is that Roche, the manufacturer of Actemra, has never warned patients or physicians about the drug’s apparent risks.
As a result, STAT writes, “patients and doctors are misled into believing [Actemra] might be safer because frequently reported, serious problems aren’t noted on its warning label.” Is this a simple case of deception? Experienced Actemra attorneys think so, arguing in recently-filed court documents that Roche lied about the arthritis treatment’s risks in a blatant attempt to sell more prescriptions than market competitors. In fact, plaintiffs’ lawyers have found early evidence that Roche may have concealed damning study evidence from the public.
More than eight years ago, before Actemra even received FDA approval, Roche’s Japanese subsidiary stepped forward with a troubling revelation. At least 15 patients involved in a Japanese clinical trial had died after taking Actemra, according to a spokesperson for Chugai Pharmaceutical. Another 221 patients had suffered severe complications, including pneumonia.
Did you or a loved one take Actemra and suffer severe cardiovascular, lung or pancreas complications? Our experienced attorneys can help. The legal team at The Product Lawyers is now offering free consultations to any patient who experienced pancreatitis, heart attack, stroke or interstitial lung disease after being prescribed Roche’s new rheumatoid arthritis drug. You can learn more about your legal options at no charge and no obligation. Just contact our lawyers now to speak with a caring legal representative immediately.
