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.
COMMON ACTEMRA SIDE EFFECTS
Actemra has been linked to an increased risk of heart failure, stroke, pancreatitis, lung disease, and gastrointestinal perforations. Symptoms of gastrointestinal issues include stomach pain, diarrhea, constipation, black or bloody stools, and vomiting. Some of the more common side effects from Actemra include:
- HIGH BLOOD PRESSURE
- NERVOUS SYSTEM ISSUES
- SEVERE ALLERGIC REACTIONS
- RESPIRATORY TRACT INFECTION
ACTEMRA + ACUTE RESPIRATORY DISTRESS SYNDROME
Acute Respiratory Distress Syndrome (ARDS) is a rapidly progressive disease. Fluid fills the lungs making them stiff and difficult to inflate. This makes it hard to breathe and can cause respiratory failure. In order to improve the amount of oxygen and reduce the work of breathing, most ARDS patients will be placed on a ventilator to support them while the lungs heal. If the inflammation and fluid in the lung(s) persist, some patients will go on to develop scarring in the lungs. To improve breathing, doctors will place ARDS patients on a ventilator. This time will help the lungs heal. However, many develop scarring in the lungs. Even with the best medical care, between 30 and 50% with ARDS die of it. Recently, evidence suggests drugs like Acterma may make the condition worse. Patients reported serious cases of ARDS while receiving treatment with anti-tumor necrosis factor (TNF) drugs or tocilizumab. However, evidence to this effect is mixed. The risk factors of ARDS in patients with RA have not been fully studied. Yet, Roche still keeps the drug on the market without warnings.
DO YOU HAVE QUESTIONS ABOUT INJURIES RELATED TO ACTEMRA?
If you or a loved one have been affected by the drug Actemra, we encourage you to consult with our team as soon as possible. With our extensive knowledge and expertise, you can rest assured that should you choose to work with us, you will have legal representation that you can trust. All initial consultations are free, and we don’t charge any up-front fees for representation. We handle all fees on a contingency basis, meaning that unless we’re successful, you don’t have to pay us. Please contact Fulmer Sill at (405)510.0077 for a free consultation.