Patients taking the Rheumatoid Arthritis (RA) drug Actemra need to be aware of a recent study by STAT News that demonstrated a very high risk of adverse side effects from use of the drug compared with other available RA drugs. According to the study, thousands of patients taking Actemra died from heart attack or lung disease. In addition, thousands of others sustained serious adverse events associated with Actemra use.
According to researchers, Actemra lacks proper warnings despite carrying a higher risk of injury than other RA drugs. Patients who have experienced a heart attack, stroke, lung disease, GI perforation or other serious physical injuries while taking Actemra should consult with a lawyer.
What is Actemra?
Actemra (tocilizumab) is a relatively new prescription drug used to treat Rheumatoid Arthritis (RA), Systemic Juvenile Idiopathic Arthritis (SJIA), Polyarticular Juvenile Idiopathic Arthritis (PJIA) and other autoimmune diseases. Recently, it was approved to treat Giant Cell Arteritis (GCA). Since its approval by the FDA in 2010, Actemra produces an annual revenue of $1.7 billion and has been prescribed over 750,000 times. It is a huge blockbuster drug for its manufacturer Roche. Roche marketed the drug as a “unique” breakthrough treatment compared to other RA drugs used as Enbrel, Humira, and Remicade.
How Does Actemra Work?
Autoimmune disorders cause the body’s immune system to attack and destroy its own joint tissue (and in some cases other tissues). This attack and destruction can cause extreme pain from inflammation and disability. Drugs like Actemra suppress the bodies immune system in an effort to prevent this destruction and inflammation. Actemra blocks interleukin-6, which in turns helps to suppress the attack of the immune system on the bodies own tissue.
Patients receiving Actemra are generally administered the drug by an IV infusion or a prefilled syringe for subcutaneous (SC) injection. Typically, patients receive a dose every 4 weeks.
Known Risks Associated with Receiving Actemra
Actemra was designed and marketed to use on patients that did not respond to Humira, Enbrel, and Remicade. The later are immunosuppressive drugs that have been available for many years to treat RA. These types of drugs generally have very strong warnings or what is referred to as a “black-box warning.” The warnings include information about the high risk of tuberculosis, fungal infections, and viral infections. The black-box warnings also give information about the high risk of adverse side effects and injury to a user’s lungs, heart, and GI system. Although these drugs can produce the intended result, they do so at great risk.
Whatever the reason, Actemra does not include any information concerning risk of injury to a user’s heart (such as a heart attack), stroke or lung diseases. NO one is yet sure why the company that manufactures and markets Actemra choose not to include these risks. The lack of these warnings was recently brought to light by a STAT News report that discussed the lack of warnings and their findings that Actemra has caused multiple serious side effects in patients. Moreover, the study exposed that despite having fewer warnings than other RA drugs, Actemra may carry a higher risk of injury.
The STAT News investigation gathered information on thousands of adverse event reports that were filed with the FDA concerning Actemra. There were 1,128 reported cardiac (heart attack) and respiratory (lung disease) deaths associated with Actemra use. In addition, there were thousands of other adverse events reported to the FDA concerning Actemra use including, but not limited to: heart attacks, interstitial lung disease, strokes, and gastrointestinal perforations. There are currently other studies being conducted to determine what other serious adverse events that may be related to Actemra use. It is important to keep in mind that these represent only the adverse events that were reported with Actemra use. It is probably safe to say that many were not.
Actemra’s Manufacturer’s Response to the Study
Despite this study, Genentech / Roche, the manufacturers and marketers of Actemra, have only agreed to review the information versus immediately issuing a warning about their drug. The FDA has yet to take significant action, which is not unusual for this bloated governmental agency. With data showing that patients taking Actemra are 1.5 times more likely to experience a heart attack or stroke than those using Enbrel and far more likely to suffer lung diseases than patients taking Remicade. It is sad Genentech / Roche don't take more responsible action to prevent further serious adverse effects in patients.
Our Drug Injury Attorneys Are Accepting Actemra Lawsuits in Kentucky Now
If you or a loved one suffered a heart attack, stroke or sustained lung disease while taking Actemra, time is of the essence in contacting a lawyer. Many states have very strict limits on the time you are allowed to bring a lawsuit for a drug injury. If you believe you may have a case, or even just have a question, do not hesitate to act.
Gray & White Law, located in Louisville Kentucky, has represented hundreds of clients in Kentucky and across the nation in pharmaceutical drug injury cases. We have been extremely successful in obtaining millions of dollars in compensation for our clients' medical costs, lost wages, and pain and suffering. We have the resources, skill, and experience to successfully handle these complex lawsuits. Contact us today for a FREE consultation.