What Is Actemra?
ACTEMRA (Tocilizumab) is an immunosuppressive biopharmaceutical drug manufactured by Roche Pharmaceuticals, a subsidiary of Genentech, that is most often prescribed to treat moderate to severe rheumatoid arthritis (RA), giant cell arteritis (GCA), active polyarticular juvenile idiopathic arthritis (PJIA), and active systemic juvenile idiopathic arthritis (SJIA).
ACTEMRA has also been prescribed in as many as 60 other off-label conditions that it has not been approved by the FDA for use to treat. ACTEMRA (Tocilizumab) belongs to a new class of DMARDs (disease-modifying antirheumatic drugs) that are called biological response modifiers or biological (BRMs). BRMs are drugs that are either made from living organisms or contain components of living organisms. They are generally derived from microorganisms, plants or animal cell, usually in the form of large complex molecules or a mixture of complex molecules by using DNA technology. Biopharmaceuticals are considered specialty drugs, which is a new classification of pharmaceuticals that are high cost.
In the treatment of RA, BRMs usually work to alter proteins called cytokines that are associated with inflammation within the immune system. BRMs used to treat RA can work several different ways, but those available on the market today usually target cytokines proteins identified within scientific and medical communities as TNFs, IL-1 and IL-6. ACTEMRA works by blocking or altering the IL-6 protein, which is active in the inflammation process of the immune system in patients with RA or other similar conditions.
When is Actemra Prescribed in the Treatment of RA?
ACTEMRA is approved for prescription in the treatment of RA or similar conditions once TNF inhibitors like ENBREL, REMICADE and HUMIRA and other methods of management have failed. TNF inhibitors have been available much longer, have been used and studied more sufficiently and have had greater success with far fewer side effects when used for long treatment in as necessary in conditions like RA than newer drugs in the BRM category like ACTEMRA, KINERET, ORENCIA AND RITUXAN.
ACTEMRA is a single dose treatment which must be administered via injection by a licensed physician or licensed physicians staff. It is usually prescribed in conjunction with other treatment options for RA including but not limited to other oral prescription medications, physical or occupational therapy and patient education.
Actemra History of FDA Approval, Side Effects, and Market Use
In 2008 at an FDA meeting regarding approval of ACTEMRA, a rheumatologist at Boston University first raised concerns about conceivable serious heart conditions and problems and ACTEMRA users. Despite these concerns, the FDA approved ACTEMRA with the condition that Roche would conduct multiyear studies to identify unseen problems and cardiovascular side effects. No warnings concerning these conceivable heart complications or the conditions of the study were added to the drug label by the manufacturer.
Following approval by the FDA, the drug was released in Japan by Roche for market use. In March of 2009, a report was submitted identifying 15 deaths and more than 200 severe side effects within the Japanese cohort taking ACTEMRA.
In 2011 Roche adds a warning concerning fatal anaphylaxis to the ACTEMRA label, following at least two patient deaths. Despite this evident serious concern among the existing small user group or the potential for more severe side effects within a larger group of users with more diverse underlying conditions , in 2012 Roche petitioned the FDA to extend ACTEMRA’s indications for use to include those who have been unsuccessful with relief from RA from only one other RA treatment drug like the more widely used and understood TNF inhibitors sold under the names of ENBREL, REMICADE and HUMIRA, instead of the standard failure of two generally warranted for this kind of approval. The petition was approved and Roche expanded market use of ACTEMRA.
By September of 2012, among ACTEMRA users, the FDA had identified 258 cases of pancreatitis and 185 cases of interstitial lung disease within clinical trials, epidemiological data and FDA adverse reports.
In 2013 the FDA began a safety review of ACTEMRA. As of August of 2012, the FDA had received over 3,500 adverse event reports implicating ACTEMRA in association with as many as 118 deaths. 42 of those deaths were reported to be due to cardiac arrest or myocardial infarction. The following year, 2014, Roche finally contributes the death of a 62-year-old German woman to ACTEMRA.
By January of 2016, the Government Accountability Office begins public awareness efforts, citing the FDA for abusing the 510(k) fast-track approval process to approve too many medications and then failing to properly monitor them once they are on the market. Regardless of this effort, Roche lobbies for an even larger prescription market with the FDA and ACTEMRA use is expanded even further to include treatment for giant cell arteritis (GA) based on a one-year study involving only 149 patients in May of 2017.
In June of 2017 STAT, a scientific and medical investigating and journalism service released its findings from an 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. In hundreds of those cases submitted to the FDA where patients were prescribed ACTEMRA for RA specifically cited heart and lung disorders and strokes as the cause of death. The FDA suspects that most major side effects are never even reported to them. Unlike many drugs competing in the same class as ACTEMRA, ACTEMRA contained no warning labels 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. The STAT report states that many of ACTEMRA’s competitors 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, guillian-barre syndrome, psoriasis, psoriatic arthritis, pancreatic cancer, and other malignancies.
If You Suffered Serious Side Effects While Taking Actemra, Our Kentucky Drug Injury Attorneys Are On Your Side
If you are a resident of Kentucky and were taking Actemra and suffered serious side effects such as heart attack or stroke, our drug injury lawyers 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.