Current treatments for rheumatoid arthritis (RA) are designed to reduce symptoms of pain and inflammation, but they can also significantly increase the risk of serious side effects. Some of the most concerning are heart attacks, heart failure, and stroke.
When manufacturers Roche and its subsidiary Genentech released Actemra (tocilizumab) in January 2010, they hailed it as a breakthrough because it worked differently than previous RA medications. The drug purportedly improved the symptoms and had a much lower risk of side effects. Whereas other RA drugs stated on their labels that they could increase the risk of heart problems, Actemra did not.
A recent STAT News report has raised concerns, however, that compared to other RA drugs, Actemra may be no safer when it comes to potential side effects and may actually present a higher risk for certain cardiac injuries. Investigators reviewed more than 500,000 side-effects reports sent to the Food and Drugs’ (FDA) adverse event database, and found that over 1,000 of people died after taking the drug.
The FDA has not determined if Actemra caused some or all of those deaths. Investigators, however, have recommended that Roche update the warnings on this drug to make sure doctors and patients are aware of the risks.
According to the Arthritis Foundation, there are more than 50 million Americans living with arthritis, and 2,984,000 of them live in Pennsylvania. The Pittsburgh lawyers at Chaffin Luhana are currently investigating cases in which Actemra caused dangerous side effects.
What is Actemra?
There are a variety of popular RA drugs on the market that work in the body to reduce RA symptoms in different ways. The precise way a drug works in the body is called the drug’s “mechanism of action”. Actemra works by targeting the interleukin-6 (IL-6) signaling pathway in the immune system. Whereas other common RA drugs target the tumor necrosis factor-alpha (TNF-a) pathway, Actemra blocks the action of IL-6, which is why it was considered new and different when it came onto the market.
RA is an autoimmune disease, which means that it causes the immune system to attack healthy tissues—in this case, in the joints and in the fluid lining the joints. As the immune system attacks, it causes inflammation, which is what leads to swelling, pain, and joint damage. Over time, RA can damage a wide variety of body systems, including the skin, eyes, lungs, heart and blood vessels.
Both of these proteins (IL-6 and TNF-a) work as part of the immune system and are involved in the inflammatory process. By blocking their action, RA drugs help to reduce inflammation to help control symptoms, while also slowing down the disease process that can lead to joint damage that typically occurs over time. Because the drugs affect the immune system, however, they can also cause serious side effects.
When you injure yourself or contract a viral or bacterial disease, the immune system rushes to the rescue to help you heal. Inflammation is part of that healing process. But when inflammation persists on a chronic basis, such as that which occurs in RA patients, the result isn’t repair, but the opposite—tissue and joint damage.
Actemra and other similar drugs help reduce the symptoms of RA by blocking the action of the immune system to some extent, but that blocking action can also interfere with the immune system’s attempts to repair other injuries or problems in the body.
How Does Actemra Cause Damage?
All “biologic” drugs like Actemra, including Humira, warn that they can cause serious infections. This is because while blocking the action of the immune system, they can reduce its ability to protect the body from bacteria and viruses that cause things like tuberculosis and other similarly dangerous infections. The warning labels state that some patients have died from these side effects.
Humira and other similar RA drugs also warn about causing new and worsening heart failure. This is another possible side effect of suppressing the immune system. Actemra, however, was advertised as being different because it blocked IL-6 instead of TNF-a. Indeed, when it was first released, the manufacturers stated in a press release that Actemra provided “a new option for patients with this very serious disease.”
Ever since it came onto the market in 2010, Actemra has been free of the product warnings about heart failure and other heart problems that appeared on similar biologic drugs. Now, new research is raising concerns that patients were injured or even died because the drug lacks appropriate warnings.
STAT Investigation Raises New Questions
According to the new STAT investigation, since 2010, a total of 1,128 people died after taking Actemra. Advera Health Analytics performed the initial review of the FDA’s Adverse Events Reporting System (FAERS), comparing data from Actemra with other RA drugs. STAT then analyzed that data and found that Actemra had a higher than expected numbers of problems compared to drugs like Humira and Remicade. The reported side effects, however, are not on the Actemra warning label.
About the same number of patients taking Actemra suffered from interstitial lung disease as patients taking Humira, for example. This side effect is listed as a possibility on the Humira product label, but not on the Actemra product label.
The investigators found similar results for other side effects, including heart failure, heart attacks, and strokes. None of these appear on the Actemra label, but Humira and Remicade both warn about heart attacks and strokes.
The STAT investigation reports that the FDA lacks the tools to confirm whether Actemra actually caused the injuries reported in the Adverse Event Reports it receives. A patient on the drug may have suffered a heart attack because he was a smoker, for instance. Still, the sheer number of patients reporting these issues raises concerns, and there is other evidence connecting the drug to heart problems, as well.
Other Evidence that Actemra May Increase Risk of Heart Problems
In one post-marketing study, for instance, researchers compared Actemra with Enbrel, another arthritis drug that warns of potential heart risks, especially in patients with pre-existing cardiovascular disease. In that study, patients taking Actemra had rates of heart failure and stroke that were 1.5 times higher than those taking Enbrel. The results were not considered to be statistically significant, but they still raised some red flags.
According to STAT News, Dr. Steven Woloshin, a professor of medicine at the Dartmouth Institute, stated that since Enbrel includes a high-profile warning about heart failure, “it is concerning that Actemra might be similar or worse.”
Another recent study comparing Actemra with other RA drugs found that the rate of heart attacks and strokes among users of all drugs was nearly identical—again, showing that Actemra may be just as risky.
Japan has also reported these issues with the drug. It was first approved there in 2008 before it came to the market in Europe or the United States. In 2009, the Wall Street Journal reported that it had been linked to 15 deaths in Japan.
Roche’s Japanese unit Chugai Pharmaceutical analyzed reports from nearly 5,000 Japanese patients who had taken Actemra between April 2008 and February 2009. They found 15 deaths that were possibly linked to the drug.
FDA Criticized for Failure to Follow-Up on Post-Marketing Reports
Though the FDA has reviewed Actemra’s safety on multiple occasions, it has not required any labeling changes regarding heart problems. (It also found evidence of a potential link between Actemra and pancreatitis, but has not yet required a warning on that either.)
The FDA’s drug monitoring system has been the subject of frequent criticism. A recent study conducted by the Mayo Clinic and the Woman’s Hospital, for example, indicated that postmarket safety events “are common after FDA approval,” highlighting the need for “continuous monitoring of the safety of novel therapeutics throughout their life cycle.”
The Government Accountability Office (GAO) also reported in 2015 that the FDA was approving a lot of drugs without clinical trials (via their fast-track approval process), even though it lacked “reliable, readily accessible data on tracked safety issues and postmarket studies needed to meet certain postmarket safety reporting responsibilities.”
Types of Injuries Associated with Actemra
Patients who take Actemra may be at risk for the following injuries:
- Heart attack
- Heart failure
- Life-threatening infections
- Gastrointestinal perforation (bowel perforation)
- Interstitial lung disease
Pursuing an Actemra Lawsuit
Actemra may be a very helpful medication for many people with RA. But these patients deserve to know exactly what they’re taking. Without full and complete information about potential drug risks and side effects, health care providers cannot make informed decisions about the best choice of treatment for their patients. It is the manufacturer’s responsibility to adequately study the drug and to be sure that the side effects listed on the warning label are the only ones that users need to be concerned about. If there are other potential side effects, especially ones that are life threatening like heart attack and stroke, patients and their doctors deserve to know, so they can weigh the benefits against the risks in their healthcare decisions.
There is evidence that Actemra may increase the risk of heart attacks, heart failure, and stroke, and so far, patients remain unaware of these risks because they do not appear on the product label.
The attorneys at Chaffin Luhana are actively investigating potential Actemra lawsuits. Patients in the Pittsburgh and Ohio Valley areas who have taken this medication and then experienced serious side effects may be able to recover damages in an Actemra lawsuit. Call today for a free case evaluation at 1-888-316-2311.