When it was first introduced in 2010, Actemra was regarded as a major breakthrough for rheumatoid arthritis. Roche/Genentech, the drug’s manufacturers, proclaims that Actemra works differently. However, the company does not warn consumers of certain serious side effects that may have played a major role in the deaths of more than 1,100 patients.
Arthritis affects millions of people, and despite the fact that there are powerful drugs available for the treatment of this condition, these drugs also cause adverse side effects that can cause serious and fatal conditions. When Actemra was approved by the FDA, Roche Pharmaceutical wasn’t required to include a warning about potential heart problems, even though the risk already existed. As such, many physicians did not screen Actemra patients for these issues and never followed them closely after treatment. This situation has led to tens of thousands of deaths as well as serious injuries.
What is Actemra and How Does it Work?
Rheumatoid arthritis (RA) is a debilitating autoimmune disease that causes inflammation in the joints of knees, feet, hands, ankles, and elbows. The inflammation occurs when the body’s immune system erroneously attacks healthy joint tissues causing swelling and pain around the joints. This inflammation can impair cartilage and bones and cause joint deformity. Over 1.5 million Americans seek treatment for this condition. One of the reasons why this treatment is very important is that once the damage is done, it can’t be reversed.
Actemra also referred to as tocilizumab, is a drug commonly used to treat rheumatoid arthritis by reducing inflammation. The drug is also used to treat Giant Cell Arteritis, a disease that causes inflammation of blood vessels in and around the scalp, and some types of Juvenile Idiopathic Arthritis, which is the most common form of arthritis in children younger than 17. The FDA approved Actemra to treat moderately to severely active Rheumatoid arthritis in cases where an adult patient has not found relief with other similar medications.
According to the FDA, Actemra can be administered by a doctor intravenously, or a patient can inject it subcutaneously. Actemra is often used when other rheumatoid arthritis drugs fail to work for the patient. According to health and medicine publication STAT, Actemra is Roche’s 5th highest grossing product, netting the company a total of $1.7 billion in global sales per year.
When the drug was being advertised, the manufacturer dubbed it a unique breakthrough that would transform expectations for patients and doctors. This arguably implied that the drug was superior to its competitors. However, studies show that patients taking Actemra face the same risks for heart failure, heart attacks, lung disease, strokes, and pancreatitis, just as those using other RA drugs. While other similar medications had warnings regarding these forms of side effects on their label, Actemra did not.
Japan Reports Issues with Actemra Prior to the FDA Approval
In 2008, Japan approved the use of Actemra even before it was approved in the U.S or Europe. According to a 2009 report by the Wall Street Journal, the drug had been linked to 15 deaths in Japan. Just as it was the case with marketing in the U.S., the drug was marketed in Japan as having minor side effects compared to other similar Rheumatoid arthritis drugs.
A few months after Actemra was approved in Japan, the manufacturers began to discover issues with the drug. Chugai Pharmaceutical, Roche’s Japanese unit, scrutinized reports for almost 5,000 patients who had used Actemra between April 2008 and February 2009. The results revealed that there were 15 deaths with possible links to Actemra. The company’s spokesperson stated that the fact that the causal relationship wasn’t denied implied the likelihood of the drug having an impact. The scrutiny further exposed 221 cases of adverse side effects.
In the U.S, the manufacturers relied on five studies to gain approval. While the FDA eventually approved the drug, the studies used showed unusual side effects, such as serious infections that could result in hospitalization and even death.
STAT News Investigation Raises Significant Concerns
An investigation by STAT News has raised new questions regarding how Actemra is being marketed and prescribed. Currently, the drug contains a black-box warning concerning infections but does not include warnings about strokes or heart issues. STAT analyzed over 500,000 adverse event reports on leading rheumatoid arthritis drugs, including Humira, Actemra, and Remicade. STAT discovered evidence that the manufacturer downplayed the drug’s cardiovascular, lung, and pancreatic side effects. Based on the findings, the FDA logged over 13,500 reports of Actemra’s adverse events between 2010 and 2016. These cases included 1,128 patients who died after using the drug. Considerably, in most of the reports, the patient’s treating physician found a link between their death and the use of Actemra.
The investigating further discovered clear evidence showing the risks of strokes, interstitial lung disease, heart attacks, and heart failures were as high or higher for patients using Actemra as those using other competing drugs. Howver, unlike its competition’s, Actemra’s warning label does not reflect these risks.
Actemra patients reported more cases of interstitial lung disease than those taking Remicade and almost the same number as those taking Humira. However, whereas Humira and Remicade have included interstitial lung disease warnings on their label, Actemra does not. STAT’s findings are backed by postmarketing studies, which are done after a pharmaceutical product goes on the market in order to have a clear picture of the risk-benefit profile.
Actemra’s postmarketing was ordered by the FDA because premarket testing revealed the potential of adverse side effects. One of the studies compared Actemra to another RA drug, Enbrel, and discovered that the rates of heart failure and strokes were 1.5 times higher in Actemra patients. While Enbrel has strong warnings for users with cardiovascular diseases, Actemra does not despite the fact that it carries similar or even worse cardiovascular risks. One study done after the drug was approved revealed that it was linked to 27 cardiac disorders plus stroke, 24 cardiac disorders, and 8 fatal and nonfatal myocardial infarctions. The second study found out that Actemra was associated with 36 cardiovascular deaths, 90 major adverse cardiovascular events, and 64 all-cause mortalities.
STAT noted that, even though Actemra had fewer reports of side effects compared to similar drugs, the higher numbers could be due to the fact that Humira and Remicade are used by much larger number of patients, and since patients those drugs are notified of the underlying risks, implying they may be more likely to watch for and report any adverse reaction as soon as they happen.
Generally, reporting of adverse reactions is low because it is voluntary and not mandatory. As such, the actual number of side effects including, Actemra stroke, heart attack, and heart failure could be higher than reported Actemra adverse events. STAT also cites experts who have indicated that the manufacturer should add warnings to the Actemra label to alert patients and doctors of the drug’s adverse events. However, Roche has not updated the warnings on the drug’s label.
Actemra’s Negative Side Effects
Before administering a drug, nearly all doctors screen their patients for possible medicine allergies and signs of infection. However, since Roche did not include warnings about Actemra’s potential to cause heart disease, most doctors don’t screen their patients for this problem because they depend on the manufacturer’s word and they don’t want to worry their clients unnecessarily.
Nonetheless, the FDA has received reports of more than 1,100 Actemra-linked fatal incidents, most of them as associated with heart or blood problems. The agency has been sluggish to take action, citing a lack of sufficient evidence. However, perhaps, the actual reason is that they do not want to accept that they erroneously approved a dangerous drug and don’t want to withdraw a lucrative product such as Actemra from the market, given that much of the agency’s budget is funded by taxes and fees on drug sales.
Some of the most serious side effects associated with Actemra include:
Hypertensive women above 60 who also use or have also used Methotrexate in conjunction with Actemra are at the highest risk for the extremely pancreatitis. An inflamed pancreas usually results in malnutrition, severe infections, kidney failure, pancreatic cancer, and breathing problems.
- Heart disease
Individuals suffering from arthritis already have greatly higher risks when it comes to heart diseases, typically because inflammation of any form is a significant cardiac health risk factor. Also, many individuals with arthritis are hypertensive, diabetic, and/or overweight. Moreover, Actemra greatly raises cholesterol levels, thus increasing the risks even further.
- Interstitial Lung Disease
Unlike cardiac and pancreatitis issues that normally manifest within a few months of Tocilizumab use, Interstitial Lung Disease (ILD) happens after long-term use of the drug. Arthritis itself is a risk factor, and because many patients taking Actemra have already suffered from moderate or severe arthritis for a certain period of time, the drug may be the last blow that causes complete damage. ILD bears a resemblance to asbestosis, given that both disorders result in the buildup of excessive scar tissue in the lungs.
Other potentially serious side effects include:
- Hypertriglyceridemia (extremely high triglyceride levels)
- gastrointestinal perforation
- life-threatening infections
Pharmaceutical Companies Have a Duty to Warn
Pharmaceutical products are not expected to be completely safe without any negative side effects. However, if a manufacturer understands that a drug carries a certain risk, it has a duty to include an appropriate warning label on the product. This is the only way doctors, and their patients can review all known benefits and risks, weigh them, and come up with an informed decision about the use of medication. Failure to do so forces doctors and patients to make medication decisions without important prescribing information.
The FDA has the discretion to demand warning labels, but the ultimate responsibility lies with the pharmaceutical companies. Unlike other competing RA drugs, Actemra has garnered FDA attention ever since it was approved. At some point, the FDA considered pancreatitis warning labels, but Genentech/Roche managed to talk the agency out of the warning. The drug was then approved for broader use for giant cell arteritis.
Actemra’s warning label mentions a risk of infections such as viral, invasive fungal, bacterial, tuberculosis, and other infections. However, it fails to warn about a risk of heart attack, pancreatitis, interstitial lung disease, and a brain bleed. Conflicts of interest between regulators and manufacturers compromise the drug safety system. STAT report reveals that all the eleven authors of an Actemra postmarketing study are believed to have had financial ties with the manufacturer. What’s more, a former FDA manager who supervised the drug's approval for RA in 2010 currently works for Roche, helping the company obtain the agency’s approval for new uses of Actemra.
When drug manufacturers fail to warn about the risk of adverse side effects, those harmed by the drug may be eligible to file a lawsuit against the big pharma for failure to warn, especially if the manufacturer knew or should have reasonably known about the risks.
FDA Did Not Follow-Up on Post-Marketing Reports
Actemra had been in the US market for 8 years when the public first learned about these potentially serious side effects. Some FDA critics suggest that the agency needs to do a better job of following up potential safety issues following a drug's approval and after it reaches the market. For instance, a recent study carried out by the Women’s Hospital and Mayo Clinic shows that the post-market safety events are common after FDA approval, insisting on the necessity for constant tracking the safety of new therapeutics throughout their life cycle.
In 2015, the Government Accountability Office (GAO) reported that the FDA was approving a lot of pharmaceutical products without clinical trials, but that they lacked readily available and reliable data on tracked safety issues. GAO also cited that postmarket studies should meet certain responsibilities for postmarket safety reporting. Based on the information provided by these sources, FDA remains ill-equipped to ensure that drug safety issues are comprehensively and timely addressed immediately, the drugs are on the market and being prescribed to millions of people.
Actemra Health Canada Liver Warnings
Health Canada, the Canadian equivalent of the FDA, issued a safety warning regarding the connection between Actemra and liver failure. The letter was published addressing healthcare experts on the agency’s website on May 21, 2019, and stated that there were reports of serious liver injury induced by the injury.
Health Canada states that reports received by the agency indicate that some individuals who took this drug suffered acute liver failure and may have had a liver transplant as a result. The letter further suggested that Actemra may not be prescribed to a patient with active liver diseases or certain levels of liver impairment. The “Dear Doctor” letter advised physicians to conduct preliminary liver function testing before therapy with Actemra is started and to repeat enzyme tests every 4-8 weeks in adults and every 2-4 weeks in children.
The Canadian Agency recommended the following specific liver enzymes for health practitioners:
- Not to prescribe the medication if their liver enzymes are three times higher than usual
- Use the drug with caution in patients whose liver enzymes are 1.5 times higher than the normal range
- Discontinue Actemra if liver enzymes are 5 times normal range
Doctors should inform their clients about the signs and symptoms of liver disease, including:
- Loss of appetite
- Dark urine
- Nausea and vomiting
- Pale feces
- Itching of skin
- Abdominal swelling
- Pain in the upper abdomen
- Yellowing of skin or eyes
The safety alert was issued following Health Canada’s demand for information from Genentech regarding the medication. The information provided in the warning was compiled from the manufacturers’ and FDA reports. While the records made it clear that Genentech knew of the risk of liver failure and injury, the company has not reviewed the drug’s prescribing information, and no similar warnings have been issued in the United States. Individuals who were injured suffered from liver failure and injury may be eligible to file Actemra lawsuits.
Actemra was approved in 2010 with prescribing information that had instructions on how to monitor liver function. Regardless of reports of serious liver injury that have been received by and the manufacturing company and the FDA, no changes have been made to the prescribing information. Moreover, the FDA has not given out any warnings in the U.S., though it seems like it has opened a tracking inquiry for liver failure, acute liver injury, and the possibility of patients needing a liver transplant following the use of Actemra.
Actemra Injury Lawsuits
The manufacturer’s failure to include warnings on Actemra’s label caused physicians to overprescribe this drug to people who were vulnerable to lung and heart injuries, without monitoring these patients for any potential harm. Thousands of individuals have already been harmed by Actemra, and many others may still be at risk of severe side effects. Many people have already filed Actemra lawsuits, and more may be expected.
In dangerous drug cases, such as those involving Actemra, a failure to warn the public triggers strict liability. It implies that the manufacturer is legally liable for damages, regardless of any actual wrongdoing or negligence. In most cases, the only real issue is whether the risk is unpredictable or obvious. Ingestible drugs should publicize all potential risks since ordinary users have no way of knowing these risks, particularly if their physicians relied on distorted information.
Lawsuits against Genentech/Roche allege that the manufacturer:
- Failed to properly test the drug prior to releasing it for use by RA patients,
- Concealed evidence of the drug’s dangers from the government and public
- Failed to warn physicians and consumers that the drug was also likely to cause severe injuries as competing RA medications
- Negligently marketed the drug and misled consumers into believing Actemra was safer than other similar drugs on the market
Plaintiffs in dangerous drug cases may receive compensation for medical costs, pain, and suffering, lost wages, loss of consortium, loss of enjoyment of life, or wrongful death. Drug manufacturers, in some cases, have been forced to pay punitive damages if it’s shown that the manufacturer knew or should have known that the drug was inherently dangerous but failed to warn consumers about the dangers. Patients or family members of those who have been injured or died after using Actemra may qualify for compensation for their injuries or losses through an Actemra mass tort lawsuit.
Actemra Lawsuits Likely to Be Handled as a Mass Tort
Pharmaceutical companies and the drug safety system can’t always be trusted to ensure the safety of patients comes first. When this happens, patients are only left with the option of turning to the legal system. Since Actemra can have different side effects, and the extent of injuries is distinct, litigation against Genentech/Roche is likely to be pursued as a mass tort. This means that each individual will have his/her own personal claim against the manufacturer of Actemra for his/her own damages. Settlements will be negotiated based on the facts of each individual case to ensure that each plaintiff receives compensation that matches up the degree of damages suffered.
As of June 2019, there have been no large group settlements for lawsuits involving Actemra and its adverse side effects, including lung injuries and heart disease. Cases like this take many years to resolve, with teams of lawyers putting in resources trying to determine how the injuries occurred and how the manufacturer could have prevented them.
Find Help for an Actemra Lawsuit Near Me
If you or a loved one has used Actemra and developed adverse reactions, or someone close to you has died; as a result, you may be eligible to participate in a mass tort to recover compensation for your injuries. It can seem intimidating facing a powerful pharmaceutical company, but a resourceful and experienced lawyer can help plaintiffs meet the corporations on an equal playing field.
Consumer Alert Now can connect you to an attorney in your area who knows how to help you through the challenging legal situation. We work diligently to see that each person who reaches out to us get access to the best legal presentation possible. Call us today at 800-511-0747 to learn more about our services.