In early 2010, The Food & Drug Administration (FDA) first approved the Roche manufactured drug, Actemra® to treat moderate to severe rheumatoid arthritis (RA). The drug works by reducing inflammation. Over 1.5 million Americans have rheumatoid arthritis, which is a debilitating autoimmune disease that causes inflammation in the joints of the hands, feet, knees, elbows, and ankles. Inflammation occurs when the body’s immune system mistakenly attacks healthy joint tissue. This results in swelling and pain around the joints. If untreated, damage to cartilage and bone can occur. In some cases, irreversible joint deformity happens. This is why treatment is vital.
Just six years after approval, the FDA received nearly 14,000 side-effect reports involving Actemra. Some also implicated that Actemra was responsible for over 1,000 deaths. The causes of death listed in the majority of these FDA reports were heart disease, lung disease, and stroke. In fact, the complaints to the FDA show that not only does manufacturer Roche fail to provide adequate warning labels, but also the drug may actually cause more adverse events than other drugs on the market. Moreover, those other drugs actually have accurate warning labels. All medications carry the risk of potential side effects. This especially is true with rheumatoid arthritis medication, which works by partially suppressing an individual’s immune system response. This is necessary to help block the protein IL-6, which causes the inflammation in rheumatoid arthritis patients. Because the immune system is being suppressed, users of Actemra need to be very careful to watch for signs of infection, such as fever, pain, difficulty breathing, urinary issues, and fatigue. If you experience these symptoms, you should immediately contact your doctor.