Actemra, a drug designed to treat rheumatoid arthritis, is under fire for causing potentially deadly side effects. Actemra (generic name: tocilizumab) was approved by the FDA in 2010, and marketed as not bearing the same risks as its competitors—yet as evidence to the contrary begins to build, some patients are filing lawsuits over allegations that the drug is causing more harm than good.
Here’s what you need to know about rheumatoid arthritis, the potential complications of Actemra, and how to get legal help if you’ve suffered serious side effects after taking it.
What Is Rheumatoid Arthritis?
Rheumatoid arthritis, or RA, is a chronic autoimmune disease, in which the immune system of the sufferer malfunctions in a way that attacks the body’s joints. Rheumatoid arthritis is relatively common in the elderly population and can be debilitating without treatment. Some of the most common symptoms of RA include:
- Joint pain
- Severe stiffness and loss of movement
- Permanent joint disfiguration
There is no cure for the disease, but symptoms can be treated and progression slowed using a variety of drugs. Methotrexate is a common chemotherapy drug that alters the immune system’s function, and it is frequently used as a first-line treatment for RA. However, methotrexate therapy doesn’t always work and may not be suitable for every patient’s specific needs, so pharmaceutical companies have been on the search for new or alternative medications for our increasingly aging population.
What Is Actemra?
Roche/Genentech’s drug Actemra was developed as part of a newer class of drugs called “monoclonal antibodies.” Monoclonal antibody drugs work directly with the body’s immune system to either enhance or suppress certain parts of the immune system, depending on the type of cancer, disease, or autoimmune disorder being treated.
Actemra functions as an immunosuppressant, and is used primarily to treat rheumatoid arthritis. It may be used alongside or in place of methotrexate therapy, and is delivered via injection, either under the skin (subcutaneously) or intravenously (into a vein).
Actemra has also gained FDA approval in recent years for the treatment of systemic juvenile idiopathic arthritis, a rare form of arthritis in children, and giant cell arteritis, an inflammatory blood vessel disease.
What Are the Risks of Actemra?
Though Actemra does carry an FDA-mandated “black box” warning about the increased risk of dangerous infections, one of the key points in the marketing of Actemra was a lack of cardiovascular and other dangerous side effects, which are a real concern when much of the patient base is elderly. Many of the other drugs used for treatment of RA are known for increased risks of these types of side effects, and carry warnings to that effect, but Actemra does not, despite the fact that it may also carry the potential risks of:
- Heart attack, heart failure, palpitations, or potentially fatal arrhythmias.
- Increased chance of a stroke, which can cause permanent disability or death.
- Pancreatitis, a dangerous infection that can lead to death if untreated.
- Interstitial lung disease, causing permanent lung damage.
- Bowel perforation, a life-threatening emergency that often requires surgery.
An investigation by STAT news examined over 500,000 reports of side effects related to RA drugs, and discovered that the risks of serious side effects like the above were actually at least as high, if not higher, than other similar RA drugs such as Humira, Enbrel, and Remicade. STAT also discovered that the FDA has received information that over 1,000 people have died after taking Actemra in the past seven years. Despite the deaths and thousands of reports of adverse reactions, the drug has not been recalled by the manufacturer or the FDA, nor have any label changes warning about the side effects been mandated by law. This “failure to warn” is now forming the basis of many Actemra lawsuits filed on behalf of injured patients—or the surviving families of those who have died after taking the drug.
How to Get Legal Help
The FDA rarely forces drug companies to recall products, and their own flawed drug approval process may allow even more drugs with undisclosed and serious side effects onto the market. That’s why it’s more important than ever for victims of dangerous drugs to take companies to task for putting profits over people, and get the justice they deserve.
If you or someone you love has been injured by the undisclosed side effects of Actemra, Wayne Wright LLP is here to help you get the answers you need. Contact our office to arrange a free consultation with us about your legal situation today.