What Is Actemra (Tocilizumab) and How Does it Work to Treat Rheumatoid Arthritis?
Actemra (Tocilizumab) is a pharmaceutical drug manufactured by Roche Pharmaceuticals (a subsidiary of Genentech), that was approved for treatment of RA in cases where patients failed both DMARD therapies and TNF antagonist therapies. Actemra was approved but the FDA in January of 2010. Actemra is the first BRM inhibitor that blocks a protein called interleukin-6 (IL-6). Actemra works by blocking IL-6 from connecting to receptor cells in the immune system. Interleukin-6s (IL-6s) are cytokines proteins and single molecules that are secreted by white blood cells. The overall function of the complete immune system is very dependent on interleukins in general. IL-6 acts as both a pro-inflammatory (cytokines proteins) and an anti-inflammatory (myokine single molecules). IL-6 is encoded by the IL-6 gene and is diversely utilized in physiological processes throughout the body and in conjunction with various cell functions. In the case of RA, IL-6 is naturally produced by cells locally in joints when they are affected by the inflammatory process. Actemra (Tocilizumab) binds to the IL-6 receptors and inhibits signaling through the receptors, thereby reducing and/or eliminating inflammation.
Besides Rheumatoid Arthritis, What Other Diseases or Conditions Is Actemra Indicated as Safe to Prescribe For?
- Giant Cell Arteritis (GCA)
- Polyarticular Juvenile Idiopathic Arthritis (PJIA)
- Systemic Juvenile Idiopathic Arthritis (SJIA)
And many other “off label” conditions.
Why Are There So Many Serious Side Effects and Devastating Risks For Patients Who Have Been Prescribed Actemra to Treat RA?
Because Actemra is a fairly new pharmaceutical and did not undergo long-term studies or clinical trial periods like competing brands, physicians and patients have relied upon information and studies provided by the manufacturer for FDA approval. Actemra manufacturer (Roche/Genentech) performed only short term studies for FDA approval, so little was known about the drug with regard to patient use and the long-term effects on the body or complications associated with underlying medical conditions when the drug was first marketed. Despite this lack of knowledge, the manufacturers proceeded to rush the drug to market to start selling.
What Is the Process for FDA Drug Approval?
In recent years, drug companies and their paid lobbyist have pushed for faster drug approval with the FDA in an effort to start selling and making profits. In some situations, however, this creates a dangerous situation of selling a drug that is not yet fully understood. Often, serious and sometimes deadly adverse side effects are not discovered during short term studies prior to release. Or worse, they are dismissed as anomalies. When drugs are marketed and sold without proper warnings physicians are mislead and patients are harmed.
Why Is the Lack of Proper Warning Labels Dangerous for Physicians and Patients Prescribing or Taking Actemra?
Competing drug manufacturers list warnings and risks of possible complications or severe side effects based on more in depth, long term studies. This process gives treating physicians and patients a sound knowledge of possibilities that can occur as related to pre-existing conditions or other health concerns. The lack of warnings or labels could lead physicians and patients to believe there aren’t any severe side effects and could, therefore, lead to more physicians and patients believing Actemra is a safer alternative than competing brands thus more distribution in lieu of other competing brands.
What Did Actemra Manufacturers (Roche/Genentech) List as Warnings, Precautions, and Adverse Reactions Associated with Actemra?
According to the FDA, the warnings and precautions for Actemra are as follows:
- Serious infections – do not administer Actemra during an active infection, including localized infections. If a serious infection develops, interrupt Actemra until the infection is controlled.
- Gastrointestinal (GI) perforation – use with caution in patients who may be at increased risk.
- Laboratory Monitoring – recommended due to potential consequences of treatment-related changes in neutrophils, platelets, lipids, and liver function tests.
- Hypersensitivity reactions, including anaphylaxis and death, have occurred.
- Live Vaccines – avoid use with Actemra.
Adverse reactions for Actemra are listed as follows:
Most common adverse reactions (incidence of at least 5%): upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, injection site reactions. There are no warning signs concerning heart attack, stroke, or lung disease.
When Were Severe Side Effects and Adverse Reactions Associated with Actemra Discovered?
What is a STAT Investigation?
STAT is a national investigating and journalism service that focuses on the world of health, science, and medicine. STAT is produced by Boston Globe Media. They are headquartered in Boston but have bureaus in Washington, New York, Cleveland, Atlanta, San Francisco and Los Angeles. They are well known and widely respected for their top notch science, health, and biotech journalism. The STAT investigations are generally conducted to a standard of accountability.
What Were the Results of the Actemra STAT Investigation?
After utilizing the freedom of information act to obtain FDA adverse event reports, STAT found that the FDA had received thousands of complaints between 2010-2106 regarding the safety and efficacy of Actemra in the treatment of RA. Actemra had been implicated in more than 1100 deaths. The causes of death in hundreds of cases where patients were prescribed Actemra were specifically cited as heart and lung disorders and strokes. The FDA said that those complaints were minimal and suspected that most major side effects are never reported to them. Actemra contained no warning labels unlike most competing drugs advising physicians and doctors of the possible severe side effects, which include heart attacks, heart failure, stroke, pancreatic complications and many lung diseases that result in death. STAT discovered that it may be causing these severe side effects at much higher rates than many other drugs in its class that are also used in the treatment of RA and that have very clear warnings and side effects listed in their literature and/or on the boxes. Actemra released a statement following the STAT investigation claiming their drug already contains the proper warnings, despite these FDA adverse event reports.
Since the STAT investigation, more studies have implicated Actemra in many other severe adverse events and medical conditions which include the following, death, heart attack, stroke, heart failure, interstitial lung disease, pancreatitis, myocardial infarction, congestive heart failure, acute myelomonocytic leukemia, bone marrow failure, synovitis, increase in knee replacements resulting from synovitis, multiple sclerosis, Guillain-Barre syndrome, psoriasis, psoriatic arthritis, pancreatic cancer, and other malignancies.
How Many Patients Have Been Prescribed Actemra Globally and How Has the Manufacturer, Roche/Genentech, Profitted?
Since approval in 2010, Roche aggressively marketed Actemra as a new breakthrough treatment for the various aforementioned arthritic conditions. It is estimated that close to a million patients have been prescribed Actemra. In 2016 financial reports show the drug generating $1.6 billion in sales for Roche/Genentech. This amount of earnings makes Actemra one of the top sellers in the global pharmaceutical market.
If You Suffered These Side Effects While Taking Actemra, Our Kentucky Drug Injury Lawyers Are On Your Side
If you were taking Actemra and suffered serious side effects, our attorneys may be able to help you. We are accepting new clients for Actemra lawsuits now, call us today at 502-210-8942 or toll-free at 888-450-4456, or complete the form on this page to request your free, no-obligation consultation with our experienced drug injury attorneys.