Actemra – Undisclosed Risk for Heart Attacks, Lung Failure, Pancreatitis
Actemra Users Also Report a Higher Incidence of Unlabeled, Adverse Events Such as Heart Failure, Stroke, and Interstitial Lung Disease.
Rheumatoid arthritis (RA) is a disabling autoimmune disease affecting roughly 1.5 million Americans. Medications like Humira, Remicade, and Enbrel help treat the condition, but they come with severe side effects, such as heart attacks, heart failure, or life-threatening lung complications – sometimes death. These warnings are disclosed on their labels.
Enter Actemra (tocilizumab) – a “unique” rheumatoid arthritis drug.
In 2010 this drug was FDA approved for use in the U.S. Roche, the drug’s manufacturer, marketed it as unique in the sense that there was no mention of the potential for heart attacks, heart failure, lung complications, or death. Doctors and patients who suffered from rheumatoid arthritis rushed to switch to Actemra and the drug became Roche’s 5th top-selling product generating $1.7 billion in sales in 2016.
Roche Failed to Warn Doctors, Patients, & the FDA About Actemra
As sales increased so did evidence that the risks of these side effects may be as high or higher for Actemra users than for patients who take the other drugs.
If you developed a heart or lung condition after taking Actemra for rheumatoid arthritis, you may be entitled to compensation. Click here to contact the Law Offices of James Scott Farrin or call us at 866-900-7078 to discuss your Actemra claim.
What is Rheumatoid Arthritis?
Rheumatoid arthritis is different than osteoarthritis, which is a disease that typically comes with aging. Rheumatoid arthritis affects more than just your joints and is not necessarily acquired with age. It is an autoimmune disorder that prompts your immune system to attack your own body's tissues. Sometimes rheumatoid arthritis can damage your skin, eyes, lungs, heart and blood vessels too.
Unfortunately there is no cure for the disease. There is, however, an enormous market for pharmaceuticals that can help alleviate symptoms.
How Does Actemra Work?
Actemra is known as a biologic drug. Biologics are designed to inhibit parts of the immune system that cause inflammation, a key factor in rheumatoid arthritis.
Rheumatoid arthritis can be activated when a chemical in your body, IL-6, connects to the cell and tells it to activate. When the cell activates, it may contribute to signs and symptoms of RA. Unlike some other rheumatoid arthritis drugs, Actemra inhibits the chemical signal IL-6.
Rheumatoid Arthritis Drugs Have Serious Side Effects
In June 2017 the investigative medical journal STAT published a shocking expose of the FDA statistics recording the adverse events of Actemra. As mentioned above, unlike similar drugs that fight rheumatoid arthritis, Actemra did not include a warning of the risk of heart or lung failure, pancreatitis, stroke, or the potential for death. The report said, “…hundreds of patients taking Actemra have died from such problems, and many more have suffered harm.”
STAT analyzed more than 500,000 side-effect reports on rheumatoid arthritis drugs, and found 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.”
There are striking empirical examples in STAT’s report. STAT discovered that “…a doctor said no factor other than the drug could have explained a 73-year-old man’s fatal brain bleed two days after receiving an intravenous Actemra treatment.” Another episode was that of a 62-year-old woman’s heart attack in 2014. The FDA found that Roche “assessed [the] fatal myocardial infarction” was the result of the effects of Actemra.
Roche (through the subsidiary Genentech) lists many of the side effects of Actemra on its website. The first three side effects listed are “serious infections,” “stomach tears,” and “changes in blood test results.” Not listed? Brain bleeds and heart attacks. Even after all these subsequent months following the STAT expose.
The STAT article offers anecdotes of patients who feel betrayed by Actemra’s failure to warn. One patient began suffering heart palpitations almost immediately after she began her Actemra treatment. Her rheumatologist, unaware of the potential side effects, sent her to a general practitioner. “When I went to the [general] doctor, they offered me an antidepressant,” she said.
Another patient developed what she described as “brain fog” after she started taking Actemra. She described instances of forgetting how to start her car and how to apply makeup. “It’s terrifying with a drug when you come to the realization that you haven’t been warned by your doctors…It kind of ruins your life.”
With more than a dozen similar drugs on the market to fight rheumatoid arthritis, consumers are relying on an accurate warning label to make an informed decision – particularly with serious side effects like heart and lung failure and death.
FDA Re-Reviewed Actemra 3 Times Since Approval
The FDA has re-reviewed Actemra three times since its 2010 approval. Yet “fatal anaphylaxis” has been the only new warning added to the label since 2011.
According to a 2012 report the FDA found 258 cases of pancreatitis and 185 of interstitial lung disease among Actemra users in clinical trials, FAERS (FDA Adverse Events Reporting System), and epidemiological data.
Actemra Lawsuits Likely to Climb
We have reason to believe things are going to get worse before they get better. In 2010, when Actemra hit the U.S. market the FDA published 263 adverse events with Actemra. In late 2017, the count was 5,483. The death count has climbed to over 1,100.
Get a FREE Actemra Case Evaluation from NC Lawyers
We believe Roche has put profits over patient safety in its repeated failure to warn of Actemra’s serious side effects.
If you or someone you love has suffered severe side effects, such as a heart attack, heart failure, or life-threatening lung complications resulting from the undisclosed side effects of Actemra, we are currently investigating claims. You may be eligible for compensation for:
- Medical expenses
- Physical and mental distress
- Lost wages
- Other expenses related to injuries suffered
Contact us immediately or call 1-866-900-7078 for a free Actemra case evaluation. Claims are subject to a statute of limitations, and in North Carolina the timeframe is only three years from the date of injury.