Actemra was developed beginning in the late 1990s by Tokyo-based Chugai Pharmaceuticals in partnership with Swiss health care company Hoffman-LaRoche. Originally a cancer drug, Actemra was first approved for the treatment of rheumatoid arthritis (RA) in 2009. Actemra received FDA approval in 2011 for the treatment of systemic idiopathic juvenile arthritis (SIJA) in children aged two and older.
Today, Hoffman-LaRoche is facing lawsuits from plaintiffs who allege that Actemra was the cause of serious injuries, which include heart failure, respiratory disease, pancreatitis and gastrointestinal perforations. Claimants site to a recent investigation by journalists for STAT News that found Actemra was implicated in the deaths of nearly 1,200 patients.
Actemra Medical Uses and Issues
Actemra is primarily indicated for adult patients suffering from moderate to severe RA when the condition has failed to respond to other therapies. It is also indicated for adults with giant cell arteritis (inflammation of the arterial lining) as well as children suffering from SJIA. In addition, physicians write “off-label” prescriptions for approximately 60 other conditions, including:
- multiple sclerosis
- polymyositis (inflammation of muscle tissue)
It should be noted that such uses for Actrema have not been tested, nor are approved by the FDA.
Most treatments for RA, which afflicts approximately 1.5 million people in the U.S., have moderate to serious side effects. These include:
- stomach injuries and irritation
- internal bleeding
- weigh gain
- abnormal fatigue
- liver damage
- eye injuries
- respiratory disease
In addition, some RA medications have been linked to an increased risk of certain types of cancer, multiple sclerosis, psoriasis and heart failure.
Actemra generated great enthusiasm when it was first introduced to the U.S. market, because according to the manufacturer the medication was not linked with the increased risks of heart attack, stroke or interstitial lung disease. Nonetheless, an analysis of over one-half million adverse event reports has shown that patients taking Actemra face risks of stroke and cardiac events at rates as high or higher than those being prescribed competing products.
The History of Actemra
Also known known by the scientific names tocilizumab and atlizumab, Actemra was originally developed as a “humanized monoclonal antibody” (antibodies genetically engineered from those of non-human species for specific therapies). Initially used to treat large-cell lung cancer, tocilizumab targets a receptor for interleukin-6 (IL-6). This is a type of protein that plays a significant role in carrying signals to cells, affecting the body's immune response. It is implicated in the development of autoimmune diseases and certain types of cancer.
Chugai Pharmaceuticals began work on tocilizumab as a treatment for RA in 1997. Additional clinical studies of the drug involving patients with Castleman Disease (a rare, abnormal, cancer-like enlargement of the lymph nodes) and Stills Disease (a type of childhood-onset arthritis) were conducted beginning in 2001.
By 2008, tocilizumab was demonstrated to be effective for the treatment of adults suffering moderate to severe RA, both alone and in combination with other therapies. Actemra was first approved for this purpose, with restrictions, by the European Medicines Agency in January 2009. The U.S. Food and Drug Administration followed suit one year later. Presently, Actemra is manufactured under license and marketed by Genentech, part of the Roche Group and based in Hillsboro, Oregon.
Profits Over Patient Safety
The companies involved in the production and marketing of Actemra have had little to say about why they neglected to provide package warnings about the dangers of the product. Dr. Jeffery Siegel, Genentech's director for rheumatology products, only says that the STAT News investigation raises “important questions that we think about all the time. … We try very hard not to be complacent, and to fully explore these issues .”
Siegel also cited a recent post-marketing study that allegedly provides “definitive” proof that there is no association between Actemra and cardiovascular disease. However, patients who participated in the study experienced a significant elevation in LDL cholesterol levels – a major risk factor for stroke and cardiac arrest. This particular study was sponsored by Hoffmann-LaRoche.
It should also be noted that currently over 760,000 patients are taking Actemra worldwide, generating $1.7 billion in revenues in 2016. This makes it Roche's fifth best-selling prescription medication. This provides LaRoche and Genentech very little incentive to be forthcoming about any dangers associated with the product.
At the same time, the FDA has been failing in its duty to protect consumers from potentially dangerous medications. Particularly since passage of the “21st Century Cures Act” in December 2016, the FDA has been giving rapid approval for new drugs before they have been adequately tested. Because of the inadequacies and incomplete data from the FDA Adverse Event Reporting System (FAERS), it has been difficult to determine in many cases whether a patient's injuries were directly related to a specific drug, or if there were other factors involved, such as concurrent medical issues and interactions with other medications.
In any event, neither LaRoche, Genentech nor the FDA have shown any interest in updating Actemra's package warning label.
Plaintiffs filing lawsuits involving Actemra claim Genentech and LaRoche were negligent in the manufacturing and marketing of the drug, which the companies knew to be dangerous, yet failed to warn consumers and health care providers of the dangers.
For extensive information on these court proceedings, visit our Actemra Lawsuit Page. This page describes in detail the litigation pending against Genentech and LaRoche, and how someone injured by Actemra can participate in the court proceedings and receive compensation for their injuries.