The rheumatoid arthritis drug Actemra has been linked to four life-threatening complications, including heart attacks and lung inflammation. Yet no updated warnings have issued from the medication's manufacturer, Swiss company Roche.
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Now, in a growing number of lawsuits, patients and families accuse Roche of failing to warn the public. Thousands more may be eligible to pursue compensation.
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Rheumatoid arthritis patients are beginning to file lawsuits against the Swiss pharmaceutical conglomerate Roche, blaming the company's new medication Actemra for causing a host of severe side effects. In their claims, the patients say they were never warned about the risk of life-threatening complications, from stroke and heart attack to debilitating lung diseases.
Actemra May Be No Safer Than Alternative Options
Current scientific research suggests that, despite marketing claims, Actemra may lead to serious complications just as frequently as its competitors, including Humira and Remicade. Since the drug's approval in 2010, the US Food & Drug Administration has received a wave of side effect reports, highlighting potential dangers that include:
- Heart attack
- Heart failure
- Interstitial lung diseases
None of these potential risks appear on Actemra's warning label. Many of them, however, are prominently advertised as known complications of other rheumatoid arthritis medications, Humira and Remicade included. In their personal injury lawsuits, rheumatoid arthritis patients say the public and medical community deserve a warning about these alleged risks, but so far, Actemra's warning label has not been updated. A number of families are also planning to file suit, attributing the death of a loved one to Actemra-linked side effects.
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A "Breakthrough" Rheumatoid Arthritis Treatment
The treatments for rheumatoid arthritis (RA) can be horrific.
The standard-of-care for new patients, according to the American College of Rheumatology, currently includes methotrexate, a chemotherapy drug. RA is a chronic autoimmune disorder, in which a patient's immune system cells mistakenly attack their own body tissues, most notably the joints. Methotrexate, along with many other medications used to treat RA, is an immunosuppressant - decreasing the immune system's ability to function. As a result, the symptoms and long-term consequences of rheumatoid arthritis can also be curtailed.
RA Drugs Come With Severe Side Effects
But suppressing the immune system comes with its own risks. Patients are left vulnerable to infections and often suffer a number of debilitating side effects, including the hair loss, chronic nausea and pain normally associated with cancer treatment. Many RA patients, especially newly-diagnosed ones, are just as fearful of receiving treatment as they are of the long-term consequences of leaving the disorder untreated.
Actemra Is Different, Roche Says
That's why Actemra was met with considerable excitement when it gained FDA approval in 2010. The biologic medication, administered either as a monthly infusion or weekly injection, had proved effective in clinical trials, manufacturer Roche said, but caused minimal side effects.
Even newer disease-modifiying antirheumatic drugs, designed to stop the chemicals that actually trigger inflammation, can result in devastating side effects. Blockbuster drugs like Humira and Remicade, for example, bear prominent warning labels notifying patients to the risk of heart attack, heart failure and interstitial lung disease, a collection of disorders that lead to scarred and ineffective lung tissue. Humira carries an additional warning for stroke.
Actemra was different, Roche said. Unlike the drug's direct competitors, Roche's new product didn't cause cardiovascular problems or lung conditions. Nor could it lead to pancreatitis, a form of pancreatic inflammation, fatal in severe cases, listed as a "rare" adverse reaction on Humira's label. Roche was offering RA patients the best of both worlds: proven benefits, few downsides.
Troubling Evidence In FDA Side Effect Reports
Shortly after being approved for the treatment of moderate to severe rheumatoid arthritis, Actemra took off, securing millions of dollars in revenue for the Swiss drug maker. Roche won at the Food & Drug Administration, too, gaining new approvals for juvenile idiopathic arthritis and giant cell arteritis, a disorder involving arterial inflammation.
At the same time, according to a new report from the healthcare journalists at STAT, patients were dying. In a sweeping analysis of side effect reports, STAT writes, "Actemra stood out." The study, performed by California-based Advera Health Analytics, found that "Actemra patients had experienced an unusually large number of serious side effects that didn't appear on the drug's warning label."
Compared to other major drugs for RA, Advera's researchers discovered an odd (some would say suspicious) trend. Patients taking Actemra and those taking Humira reported severe side effects, like interstitial lung disease or heart attack, at almost identical rates. Humira and Actemra, the analysts concluded, may actually carry the exact same risks for life-threatening complications. The only difference? Humira warns doctors and patients. Actemra doesn't.
Some of these side effects are true medical emergencies. Pancreatitis, an exceedingly rare form of inflammation in the pancreas, can lead to kidney failure. It also increases the risk for pancreatic cancer and, when left untreated, is almost always deadly.
The FDA has received 132 reports of Actemra patients developing the condition; 26 of those people have died. Dr. David Felson, a rheumatologist at Boston University, thinks those numbers are too high. "I would be worried," Dr. Felson told STAT in an interview.
Interstitial Lung Disease
Neither Humira nor Remicade warn about pancreatitis, but the same can't be said in the case of interstitial lung disease. A general category of lung disorders, interstitial lung diseases lead to inflammation, scar tissue development and thickening in the interstitium, a fine network of tissues that support the lung's air sacs. These disorders can literally starve the body for oxygen, as clotting scar tissue progressively squeezes the air sacs and prevents them from filling with air.
The warning labels for Humira and Remicade have contained references to interstitial lung disease and pulmonary fibrosis (a specific name for scarring in lung tissue) for nearly a decade. The FDA has received 222 reports of interstitial lung disease in Actemra patients. Almost the same number, 234 cases, have been reported in Humira patients, despite Humira being a far more popular medication. But the warning label for Actemra doesn't mention interstitial lung disease or pulmonary fibrosis once.
Long-Term Studies Find Signs Of Risk
Requiring a labeling change based solely on FDA side effect reports would be careless. Adverse event reporting is voluntary in the vast majority of cases and some estimates suggest that the FDA is only notified of around 10% of the complications that actually occur. It's a very limited slice of a very large problem.
To estimate risk levels more accurately, researchers design complex long-term studies of actual patients. When the FDA approved Actemra, it did so on the condition that Roche would conduct a number of long-term safety studies, the results of which would be used to update the drug's safety information and inform the public.
Stroke & Heart Failure
One of these studies looked at Actemra's cardiovascular effects and compared it to a different RA drug, Enbrel.
Enbrel already has a warning about heart failure, cautioning physicians to avoid the drug for patients with a history of cardiovascular disease. And in their study, presented at a meeting of the American College of Rheumatology, researchers from Columbia University found that Actemra patients actually suffered heart failure and stroke about 50% more often than people on Enbrel.
The increased risk is probably pretty small, considering that patients with rheumatoid arthritis are already at an increased risk for cardiovascular problems. But the fact remains that Enbrel warns about these problems and Actemra doesn't, even though Actemra seems to contribute to more heart disease than Enbrel. This is troublesome, says Dr. Steven Woloshin, a professor at the Dartmouth Institute for Health Policy and Clinical Practice. "Since Enbrel includes a high-profile warning and precaution in the label about heart failure," Dr. Woloshin continued, "it is concerning that Actemra might be similar or worse."