The Actemra lawsuit claims the rheumatoid arthritis medication increases the risks of heart failure, stroke, pancreatitis, lung disease, and gastrointestinal perforations (holes and tears).
Why Are Actemra Lawsuits Being Filed
Plaintiffs attorneys claim patients being treated with Actemra are at the same risk (if not higher) of suffering a heart attack, stroke and interstitial lung disease as individuals using other arthritis medication, such as Enbrel, Humira, and Remicade.
The big difference, however, is that Actemra has been widely marketed as not carrying these risks, while competitor drug companies have specifically warned the medical community to be more cautious prescribing their drugs to patients with preexisting issues.
The failure of Actemra to carry a proper warning has led doctors to over prescribe this medication to individuals who are susceptible to heart and lung injuries, and resulted in doctors failing to monitor these patients more closely for potential harm.
The lawsuits allege that Roche/Genentech (the manufacturer of Actemra): (i) failed to properly test Actemra before placing it on the market; (ii) failed to warn doctors and patients that the medication was just as likely to cause serious injuries as competing drugs; (iii) concealed evidence of the dangers of the drug from the federal government and public; and (iv) misrepresented the safety of the medication in its marketing material and publications.
According to the news organization STAT, which specializes in medical journalism, patients taking Actemra are 50% more likely to suffer a heart attack or stroke than patients using Enbrel. Similarly, Actemra users are more likely to suffer a lung disease than those taking Remicade.
Actemra Injuries & Side Effects
All medications carry the risk of potential side effects. This especially is true with rheumatoid arthritis medication, which works by partially suppressing an individual's immune system response. This is necessary to help block the protein IL-6, which causes the inflammation in rheumatoid arthritis patients.
Because the immune system is being suppressed, users of Actemra need to be very careful to watch for signs of infection, such as fever, pain, difficulty breathing, urinary issues, and fatigue. If you experience these symptoms, you should immediately contact your doctor.
Actemra users should carefully watch for signs of an allergic reaction to the medication, such as hives, chest pain, swelling and breathing difficulty. Patients should also avoid receiving a "live" vaccine, such as the shingles vaccine or the nasal spray flu vaccine.
Actemra has been found to potentially cause serious infections in juvenile idiopathic arthritis patients, which infections can include a form of herpes as well as tuberculosis and a fungal infection known as systemic mycoses.
As highlighted throughout this website, Actemra has been linked to an increased risk of heart failure, stroke, pancreatitis, lung disease, and gastrointestinal perforations. Symptoms of gastrointestinal issues include stomach pain, diarrhea, constipation, black or bloody stools, and vomiting.
Some of the more common side effects from Actemra include: headaches, high blood pressure, nervous system issues, severe allergic reactions, and respiratory tract infections.
Before taking Actemra, make sure to inform your healthcare provider if you have a history of a weakened immune system, liver disease, or tuberculosis.
The FDA's unwillingness to require Actemra to carry a warning related to heart failure and pancreatitis has become an example of the FDA's premature approval of medication and its inability to timely take corrective action when dangers become evident.
According to Dr. Vinay Prasad, an oncologist and medical ethicist at the Oregon Health and Science University, “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.”
Video: The Link Between Actemra and Heart and Lung Issues
How Much Compensation Can I Recover in an Actemra Claim
If you were injured by taking Actemra, then you are entitled to seek the following types of recovery:
- Past and future medical expenses that result from any injuries caused by your use of Actemra which Roche/Genentech failed to warn doctors and patients.
- Past and future pain and suffering caused by the injuries, and the treatment and recovery process.
- Past and future wage loss, if any.
- Punitive damages, if appropriate.
As of May 2018, there have been no large group settlements involving Actemra and the potential link to heart and lung injuries. Litigation likes this takes many years to resolve, with teams of lawyers spending millions of dollars trying to determine exactly what occurred, and how it could have been prevented.
Generally, large groups of settlements do not occur until such time as a few cases are tried before a jury, and the manufacturer is able to more thoroughly understand its financial risk.
What is the Purpose of Actemra
Actemra (tocilizumab) is an injectable or intravenous immunosuppressive drug used to treat the symptoms of moderate to severe rheumatoid arthritis. The medication was first approved by the FDA in 2010, and is sold by Roche/Genentech.
In 2017, the FDA additionally approved use of the drug for Giant Cell Arteritis. The medication also is used to treat polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis in children ages two and older.
Actemra is the company’s fifth highest grossing product, with more than 760,000 individuals using it worldwide, creating approximately $1.7 billion in revenue for Roche/Genentech.
Actemra was originally developed as a “humanized monoclonal antibody”, and was used to treat large-cell lung cancer. It targets a receptor for interleukin-6 (IL-6), which is a type of protein that plays a significant role in carrying signals to cells, affecting the body's immune response.
Rheumatoid arthritis is an autoimmune disease that causes chronic inflammation, with periods of exacerbation and remission. Symptoms include joint pain, stiffness, swelling, loss of range of motion, and deformity.
The disease affects approximately 1.5 million people in the United States, with women being far more likely to be impacted. While rheumatoid arthritis generally is associated with joint issues (especially in the hands), it also can attack other organs, including the heart, lungs, eyes and skin.
Rheumatoid arthritis is a permanent condition with no known cure. It can affect people of all ages, and the cause is not specifically known. Treatment involves medication, exercise, rest and surgery. The sooner treatment is begun the better the long-term outcome.
Actemra Lawsuit News
STAT analyzed more than 500,000 reports of adverse events during treatment with RA drugs and found evidence that the risks of heart attacks, strokes, heart failure, and other conditions were as high or higher for patients treated with tocilizumab than for patients treated with some competing drugs. Most of those medications warn about these risks on their labels. Tocilizumab does not. Reported in Managed Care Magazine - Actemra Related DeathsA Drug Causes Hundreds of Deaths and Millions of ADEs
Actemra hit the market in 2010 and many were excited for its apparent benefits over other RA medications. Unlike other drugs, it didn’t have issues relating to heart attacks, heart failure, or lung problems. However, after investigating 500,000 side-effect reports on RA drugs, the STAT investigation found that these risks are as high or even higher with Actemra than with other RA drugs. Reported in Drug Topics - Actemra Adverse EventsArthritis Drug Actemra Linked to Heart Failure, Death
Actemra competes with other drugs for arthritis, such as Humira, Remicade and Enbrel. These other drugs carry warnings about the risk of heart failure, heart attacks, and strokes — Actemra does not. Reported in Daily Hornet - Actemra & Heart Failure
The FDA has received reports of 1,128 deaths among patients who were taking Actemra, although the agency is not able to assess whether the medication directly contributed to the deaths, according to STAT. Neither the FDA nor Roche has made an effort to change the drug's label. Reported in Becker’s Healthcare - Arthritis Medication Linked to Deaths
For additional news stories, click Levin Actemra News
FDA and Scientific Studies Regarding Actemra
Failure to warn: Hundreds died while taking an arthritis drug, but nobody alerted patientsSTAT performed an analysis of over 500,000 FDA reports on a variety of rheumatoid arthritis medications, which included 13,500 reports involving Actemra. The investigators found hundreds of examples of people dying from heart failure, pancreatitis and other conditions not warned about. The researchers concluded there was “clear evidence that the risks of heart attacks, strokes, heart failure, and other conditions were as high or higher for Actemra patients than for patients taking some competing drugs.” Reported in STAT - Actemra Investigation
Actemra Recall Information
As of this time, there has not been a recall of Actemra related to heart problems, stroke, pancreatitis, lung disease, or gastrointestinal perforation.
However, the investigation into Actemra, from a legal standpoint, is still at the early stages. It often takes many years; tens of thousands of hours of attorney time; and the expense of many millions of dollars before all the facts come out that will lead to a recall.