Actemra Lawsuit

Why Are There Actemra Lawsuits?

Arthritis medications, like Enbrel, Humira, and Remicade, have warnings for increased risks of heart attack, stroke, and interstitial lung disease. Actemra was marketed as the opposite, leading doctors to prescribe patients Actemra more than other arthritis medications. 

However, it has been reported that Actemra may cause an increase in these same medical issues. Manufacturers has not issued warnings that Actemra can increase the risk of heart failure, strokes, and lung diseases. This may have led to patients being negatively affected by Actemra. 

Why Have Plaintiffs Filed Actemra Lawsuits?

Plaintiffs have claimed that the manufacturers of Actemra have: 

• Failed to properly test Actemra before placing it on the market
• Failed to warn doctors and patients that the medication was likely to cause serious injuries as competing drugs
• Concealed evidence of the dangers of the drug from the federal government and public
• Misrepresented the safety of the medication in its marketing material and publications

Some of the injuries that plaintiffs have claimed to experience are: 

• Heart failure
• Stroke
• Pancreatitis
• Lung disease
• Gastrointestinal perforations

Which Companies Are Facing Actemra Lawsuits?

The only company reported facing Actemra lawsuits as of 2023 is Roche/Genentech. 

What Actemra Lawsuits Settlements Have There Been?

There have been no large group settlements involving Actemra and potential dangerous effects. 

What Actemra Lawsuits Are There?

As of 2023, there are no active Actemra Lawsuits. 

What Is Actemra?

Actemra, also called Tocilizumab, is in a class of drugs called biologics. Biologics are large molecules produced in living cells and help protect against the effects of inflammation. 

How Does Actemra Work?

Actemra works by blocking action of a protein in your body called interleukin (IL-6) which is believed to cause the symptoms of rheumatoid arthritis (RA). 

IL-6 connects to the cell and tells the cell to activate. When the cell activates, it may contribute to the signs and symptoms of RA. Actemra blocks IL-6 from connecting the cell, preventing the cell from activating. This lowers the symptoms of RA. 

Which Company Created Actemra?

Tocilizumab was originally developed by drug companies Hoffmann-La Roche and Chugai under the market name “Actemra” in 1997.  In 2023, Roche and their subsidiary, Genentech, are the sole producers of Actemra. 

When Was Actemra Approved by the FDA?

The FDA first approved Actemra for the treatment of moderate to severe rheumatoid arthritis in January 2010. 

In 2017, the FDA additionally approved Actemra 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.

What Is Actemra Prescribed To Treat?

Actemra is a treatment for adults with moderate to severe RA, giant cell arteritis, and polyarticular and systemic juvenile idiopathic arthritis. Actemra should only be prescribed to individuals who have tried and failed another RA medication before taking Actemra. 

What Are the Side Effects of Actemra?

There are a number of ranging side effects that patients may experience when taking Actemra. 

What Are the Common Actemra Side Effects?

Common side effects of Actemra include: 

• Abnormal liver function tests
• Common cold
• Dizziness
• Headache
• Increased blood pressure
• Pain, swelling, burning, itching, or irritation on the injection site
• Runny or stuffy nose
• Sinus pain
• Sore throat

What Are the Adverse Actemra Side Effects?

Some of the more rare and severe side effects of Actemra include: 

• Gastrointestinal Perforation
• Severe Allergic Reactions
• Infections
• Heart Failure
• Stroke
• Pancreatitis
• Lung disease
• Increased risk of serious infections

You should inform your doctor if you have a history of a weakened immune system, liver disease, or tuberculosis. Actemra can cause increased effects in patients with these past conditions. 

What Is Gastrointestinal Perforation?

A gastrointestinal perforation is a tear or hole in the wall of the stomach or the intestines. This can lead to inflammation or infection of pouches in the colon known as diverticulitis. 

Perforations can be caused by all types of cancer, Crohn’s disease, ulcerative colitis, and other diseases of the body. Symptoms of a gastrointestinal perforation are: 

• Severe abdominal pain
• Chills
• Fever
• Nausea
• Vomiting 
• Shock

What Are the Signs of a Severe Allergic Reaction?

Signs of a severe allergic reaction to Actemra may include erythema (redness of the skin) and urticaria (skin rash with red, itchy bumps or hives). If experiencing these allergic reactions, contact your doctor and ask about discontinuing your use of Actemra. 

What Are the Signs of an Infection?

Infections can show up in many ways in the body. Some indicators to watch out for when taking Actemra may be: 

• Feeling tired
• Losing appetite
• Clay-colored stool
• Vomiting
• Chills 
• Dark urine
• Stomach discomfort
• Rash
• Fever
• Muscle aches
• Yellow skin or eyes

What Are the FDA’s Warnings About Actemra?

There is currently a black box warning on all Actemra labels to warn patients about the serious risks that may lead to hospitalization or death. The notice includes warnings of serious infections such as active tuberculosis, invasive fungal infections, bacterial and viral infections, as well as other infections caused by opportunistic pathogens. 

The FDA also warns that the risks and benefits should be considered when taking/prescribing Actemra. Patients taking Actemra should also be closely monitored for any adverse side effects after taking Actemra. 

What Is a Black Box Warning?

A black box” warning is the highest safety-related warning the Food and Drug Administration assigns. These warnings can be added, updated, or removed depending on what the FDA determines is necessary. Black box warnings are specifically used to warn consumers of the major risks of a certain drug.

What Is Actemra Prescribed To Treat?

Actemra is prescribed to treat rheumatoid arthritis and other immune disorders, most commonly, severe RA that hasn’t responded to other treatment options. Actemra is typically the last resort if other medications haven’t worked.

What Is Rheumatoid Arthritis?

Rheumatoid arthritis is an autoimmune disorder that causes chronic inflammation in the lining of the joints. In people who have RA, the body’s immune system mistakenly attacks its own tissues. This can cause swelling and inflammation that can, over time, erode bone and deform joints. The inflammation can also damage the lungs, heart, skin, eyes, blood vessels, and other bodily systems.

What Are the Symptoms of Rheumatoid Arthritis?

Symptoms may be more severe at certain times than others. These are called flares and may alternate with remission periods in which symptoms either lessen or disappear altogether.

The symptoms of rheumatoid arthritis can include:

• Joints that are tender, warm, and swollen
• Fatigue
• Fever
• Loss of appetite
• Joint stiffness (especially after periods of inactivity or in the morning)

Early on, rheumatoid arthritis may tend to attack smaller joints first, usually the ones in the fingers and toes. The disease may then spread as it progresses, impacting the wrists and ankles, knees and elbows, shoulders and hips. Typically, the disease impacts the same joint on both sides of the body.

What Body Systems Can Rheumatoid Arthritis Affect?

In addition to the joints, rheumatoid arthritis may also affect the following bodily systems:

• Blood vessels
• Bone marrow
• Eyes
• Heart
• Kidneys
• Lung
• Nerve tissues
• Salivary glands
• Skin

Is Actemra Still on the Market?

As of 2023, Actemra is still on the market. The use has been limited to those who have tried other RA drugs and were unsuccessful in their treatment.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.