Actemra is a prescription immunosuppressive drug used to treat adults with moderate to severe rheumatoid arthritis (RA), giant cell arteritis, polyarticular idiopathic arthritis, and systemic juvenile idiopathic arthritis. Actemra is usually given after other medications have been tried without successful treatment of symptoms. This medication is administered by monthly intravenous infusions and is manufactured by Roche - Genentech.
In 2010, Actemra was hailed as, “the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody for RA.” RA is caused by inflammation in the body. IL-6 is the protein in the body that causes the inflammation. Actemra is comprised of a man-made protein that binds to interleukin-6 (IL-6) and blocks its effects to reduce inflammation and the problems associated with it such as sore muscle joints.Approximately 1.5 million Americans suffer from RA and Actemra was hailed as a “breakthrough” medicine since it wasn’t reported to have the dangerous adverse effects such as heart attacks, strokes and other debilitating injuries associated with its many competitors. Since these conditions weren’t apparent in the company’s short term studies, Roche-Genentech wasn’t required to add a warning for these injuries on their label.However, the FDA clearly instructed Roche-Genentech that follow-up studies were needed to supplement the short term studies that were submitted. The FDA stated in their approval letter to Roche-Genentech that, “Section 505(0)(3)(E)(ii} of the FDCA requires you to report periodically on the status of any study or clinical trial required under this section. This section also requires you to periodically report to FDA on the status of any study or clinical trial otherwise undertaken to investigate a safety issue. Section 506B of the FDCA, as well as 21 CFR 601.70, requires you to report annually on the status of any postmarketing commitments or required studies or clinical trials.”
Unfortunately, time has shown that Actemra is not the miracle cure that it was heralded to be. According to Charles Pillar of STAT News, “STAT analyzed more than 500,000 side-effect reports on rheumatoid arthritis drugs, and found clear evidence that the risks of heart attacks, strokes, heart failure, and other conditions were as high or higher for Actemra patients than for patients taking some competing drugs.”Actemra can be dangerous, but unfortunately there is no data that accurately reflects the potentially tens of thousands of patients who have sustained injuries due to taking Actemra. What most people don’t know is that the FDA makes it extremely hard to file a report and then never follows up on the majority of complaints submitted. According to NPR, “The FDA's system for reporting drug- and device-related health problems is voluntary. The reports are not verified, and critics say this system is underutilized and filled with incomplete and late information. The FDA also monitors other available studies and reports to determine whether it needs to take action on a particular drug.”Here are some the the dangerous potential adverse effects that you should be aware of (but keep in mind, in reality, these numbers are much higher):
