Sanders Phillips Grossman Actemra litigation attorneys are representing clients nationwide in a lawsuit against the drug manufacturer, Roche/Genentech, for failure to warn the medical community and public about the risks of heart attack, heart failure, stroke, pancreatitis, lung disease, gastrointestinal perforation and death in patients when taking Actemra for rheumatoid arthritis (RA) or giant cell arteritis (GCA). A recent article published by STAT tells of hundreds of people taking Actemra who have died from heart attacks, stroke, heart failure, and lung complications, revealing that life-threatening complications are occurring at the same frequency with Actemra as they are with other rheumatoid arthritis medications. However, while other manufacturers choose to warn the medical community and public of these risks, Roche/Genentech does not.
- Actemra was approved by the FDA to treat rheumatoid arthritis in January 2010 and later approved to treat Giant Cell Arteritis in May 2017.
- There have been 1,128 death reports to the FDA regarding Actemra patients.
- Globally, more than 760,000 patients have used Actemra. The drug is Roche’s fifth-highest in gross sales, having brought in $1.7 billion in 2016.
“Law Firms Watching Actemra Story”
September 20, 2017, by Brenda Craig
Law firms across the US are taking a serious interest in a recent investigative piece of journalism by STATnews published on June 5, 2017, which revealed, “The Food and Drug Administration has received reports on 1,128 people who died after taking Actemra, and has reviewed its safety several times since it was approved. But the agency doesn’t have sophisticated tools to determine whether the drug was a culprit or a bystander in those deaths.”
Among those firms whose antennae went up is Sanders, Phillips, Grossman, a national law firm well-known for acting on behalf of consumers injured by defective drugs.
“It definitely has got our attention. I think there is some thick black smoke. That black smoke could erupt into flames tomorrow, and we are watching it carefully,” says Dr. John Restaino from Restaino Law in Colorado.
Dr. John Restaino, an attorney and epidemiologist is currently involved in gathering and evaluating information coming forward about Actemra in conjunction with Sanders, Phillips, Grossman’s current study of the issue.
“The STAT report is based on adverse events sent to the FDA. I think that is very important. I think that is evidence,” says Dr. Restaino. “Right now what we really have with this drug is increased reports to the FDA. What I am hoping to see soon is some real solid epidemiology.”
Dr. Restaino is quick to point out Rheumatoid Arthritis disease comes with a risk of cardiovascular problems. “There are cardiovascular deaths for patients taking the drug but there is an increased risk for cardiovascular death in rheumatoid arthritis by itself,” Dr. Restaino.
The drug was hailed a revolutionary treatment when it was first approved for use by the FDA in 2010. Similar drugs for the estimated 1.5 Americans suffering from this debilitating disease were associated with heart attacks, strokes, and heart failure and came with a warning label. However, Actemra was the exception and requires no such warning label.
“This has enough of an interest that I would assume that the manufacturer is doing a study or two or three. I would also assume that a lot of rheumatologists want to know the answer,” says Dr. Restaino who is also an associate professor at the University of South Carolina.
“We talked about doing a study ourselves at the University of South Carolina – a case-controlled study. So I am sure there are people doing it, we’re waiting for the studies to get done and to go through the peer-reviewed process and to get published,” he adds.
STAT is a national publication “focused on finding and telling compelling stories about health, medicine, and scientific discovery”. It is owned by the Boston Globe Media. Although the story raised questions it also made clear that the FDA information alone does not constitute a definite answer as to the safety of the drug.
Where the investigation by law firms leads is at the moment unknown. For individuals taking Actemra, Dr. Restaino says, “They should keep themselves informed.”
What is Actemra?
Actemra (tocilizumab) is a prescription drug approved to treat moderate to severe rheumatoid arthritis (RA) or giant cell arteritis (GCA) in adults, and polyarticular juvenile idiopathic arthritis (PJIA) or systemic juvenile idiopathic arthritis (SJIA) in children ages two and older.
How is Actemra administered?
Intravenous Infusion (IV) for RA, PJIA, and SJIA:
It takes about one hour to administer one full dose of Actemra intravenously. For RA or PIJA, dosages are approximately every four weeks. For SIJA, dosages are approximately every two weeks.
Subcutaneous Injection (SC) for RA and GCA:
Actemra can also be prescribed as single-use, prefilled syringes to be injected under the skin at home. Your healthcare provider should provide training on how to administer these injections yourself, including instructions on how much medicine to use and when.
Who is the manufacturer of Actemra?
The manufacturer of Actemra is Roche/Genentech.
Has Actemra been approved by the FDA?
Yes, Actemra was approved for use in January 2010. If you would like to report side effects of Actemra to the FDA, their phone number is 1-800-FDA-1088.
What are the side effects of Actemra?
The Genentech website lists the most common side effects as:
- Upper respiratory tract infections (common cold, sinus infections)
- Increased blood pressure (hypertension)
- Injection site reactions
- Hepatitis B infection in people who already carry the virus, it may activate the virus
- Serious allergic reactions that could lead to death
- Nervous system problems such as Multiple Sclerosis
However, a recent STAT investigation found that hundreds of people have died while taking Actemra and is urging the FDA to change the warning label to include additional side effects such as:
- Heart failure
- Heart attack
- Interstitial lung disease
After analyzing adverse event reports that had been submitted to the FDA, STAT found “1,128 deaths and thousands of serious side effects, including heart attack, stroke, heart failure, interstitial lung disease, and pancreatitis.”
Is this a class action lawsuit?
No, we intend to pursue the litigation against Roche/Genentech as a mass tort, which means each individual we represent will have his or her own individual claim against the drug manufacturer for his or her own distinct damages because of the nature and extent of injuries are separate and distinct. We will negotiate settlements considering the facts of each individual case to ensure compensation to the degree of damages suffered. Damages typically include such things as pain and suffering, loss of enjoyment of life, loss of consortium, medical expenses, wage loss, and more.
What will an attorney cost me?
We represent our clients on a contingency fee basis. This means that you pay no attorney fees until we win your claim. If we are unable to successfully resolve your claim, you are not obligated to pay attorneys’ fees.
ACTEMRA FOR RHEUMATOID ARTHRITIS AND GIANT CELL ARTERITIS
Rheumatoid arthritis affects about 1.5 million Americans and it is well known that treatments for the disease can cause debilitating side effects such as heart attacks, heart failure, and lung issues. That’s why when Actemra was introduced to the United States market in 2010, doctors and patients were encouraged to hear that the drug was not associated with these serious side effects.
However, after a review of 500,000 reports of patients taking Actemra, it appears that Actemra does indeed carry the same risks. There have been 1,128 death reports linked to Actemra and STAT has reported heart and lung-related side effects are “as high or higher for Actemra patients than for patients taking some competing drugs.”
In one case, a physician noted “no factor other than the drug could explain it” after the death of a 73-year-old man by brain hemorrhage two days after receiving Actemra intravenously.
Another physician blamed a 62-year-old woman’s heart attack on the drug stating, “the company assessed fatal myocardial infarction as related to (Actemra).” The company was Roche, manufacturer of Actemra.
ACTEMRA VS. HUMIRA, REMICADE, EMBREL
In a head to head comparison, STAT found that patients taking Actemra were 50% more likely to have a heart attack or stroke than patients taking Enbrel, yet Embrel warns of these potential heart problems while Actemra does not.
STAT also reported the same number of interstitial lung disease incidents in patients taking Actemra vs. Humira, and more occurrences than in patients who took Remicade. Humira and Remicade are competing for drugs whose manufacturers warn of these risks, while Actemra does not.
THE FDA AND ACTEMRA
Experts who reviewed the STAT data have urged the FDA to issue warnings for the side effects of heart failure and pancreatitis, citing that Actemra in its acute form can be deadly in 50% of patients. They also spoke of “the FDA’s inability to adequately scrutinize the safety of drugs after they have been approved and to act promptly when potential danger signs appear.”
To date, the FDA’s response has been that it lacks the necessary, sophisticated tools to determine that Actemra is the cause of the 1,128 deaths.
“We’ve done a very good job of making it easier to approve drugs, often based on very preliminary evidence. But we haven’t ramped up the standards of post-marketing surveillance to make sure that what’s been out there for several years is safe and effective,” said Dr. Vinay Prasad, an oncologist and medical ethicist at the Oregon Health and Science University. “The system is broken, and all the financial incentives are lined up to keep it broken.”
In 2015, The Government Accountability Office published a drug safety memo stating:
“FDA lacks reliable, readily accessible data on tracked safety issues and post-market studies needed to meet certain post-market safety reporting responsibilities and to conduct systematic oversight. Tracked safety issues are potential safety issues that FDA determines are significant and that it tracks using an internal database. Internal control standards for federal agencies specify that information should be recorded in a form and within a time frame that enables staff to carry out their responsibilities and that relevant, reliable, and timely information should be available for external reporting purposes. However, evaluations conducted by CDER of data in its database revealed problems with the completeness, timeliness, and accuracy of the data. These problems, as well as problems with the way data, are recorded that impair their accessibility, have prevented FDA from publishing statutorily required reports on certain potential safety issues and post-market studies in a timely manner, and have restricted the agency’s ability to perform systematic oversight of post-market drug safety. Although the FDA has taken some steps to address the problems with its data, the agency lacks plans that comprehensively outline its efforts and establish related goals and time frames. Additionally, FDA does not have plans to use these data to inform its oversight of its expedited programs, such as determining if drugs that used an expedited program were subsequently associated with tracked safety issues at rates or of types that differed from drugs that used FDA’s standard process.”
When questioned about Actemra, the FDA declined to comment and instead, provided this written statement: “[the FDA] continually monitors post-marketing safety of approved drug products and remains committed to informing the public in a timely manner when the FDA identifies safety issues.”
Reminiscent of Vioxx
In 2008, when FDA scientific advisors met to discuss the approval of Actemra, they recalled a notorious error made years earlier in the approval of another arthritis drug, Vioxx. Although the risk of heart attack had not shown up in short-term clinical trials used in Vioxx’s approval process, tens of thousands of patients ultimately died of heart attacks linked to the drug.
According to a transcript of that Actemra meeting, Dr. David Felson, a Boston University rheumatologist said, “I can foresee the possibility that in five years there’s another hearing like the one on Vioxx, where the cardiologists… say to us, what were you guys thinking when you approved this drug?”, noted that patient blood test data showed elevated levels of cholesterol and triglyceride, which could mean serious heart problems for patients in the long run.
ACTEMRA SIDE EFFECTS
Actemra is FDA approved for treating rheumatoid arthritis and giant cell arteritis but sometimes doctors will prescribe the drug for off-label use for about 60 conditions.
Life-threatening side effects may include:
- Heart Attack
- Heart Failure
- Interstitial Lung Disease
- Gastrointestinal Perforation
Other common side effects may include upper respiratory tract infections, runny nose, headache, high blood pressure, increased ALT levels in blood tests, and injection site reactions.
ABOUT SANDERS PHILLIPS GROSSMAN
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