People who have received eculizumab (brand name Soliris) are at high risk (1,000 to 2,000-fold greater), for invasive meningococcal disease compared to the general United States population. Life-threatening and fatal infections have occurred in some patients treated with Soliris. These infections may become rapidly deadly if not recognized and treated promptly, according to RxList.
What is Soliris?
Soliris is used to treat two rare blood disorders, paroxysmal nocturnal hemoglobinuria (PNH) that can cause a decrease in red blood cells (anemia). Soliris helps to block the decrease in red blood cells and can improve the symptoms of anemia such as tiredness, shortness of breath, and can decrease the need for blood transfusions.
Soliris is also used to treat atypical Hemolytic Uremic Syndrome (aHUS). The medication helps to prevent blood clots caused by this disorder, according to WebMD. This is a genetic, chronic, rare disease that can progressively damage vital organs, potentially lead to stroke, heart attack, kidney failure, and premature death. It is caused by genetic abnormalities that result in chronic uncontrolled complement activation leading to complement-mediated thrombotic microangiopathy (TMA), the formation of blood clots in small blood clots throughout the body.
Atypical Hemolytic Uremic Syndrome affects both children and adults and patients with aHUS face a lifelong risk of TMA. This disorder may lead to sudden, catastrophic, and life-threatening damage to the kidney, brain, heart, and other vital organs.
National law firm Parker Waichman LLP is actively reviewing potential lawsuits on behalf of individuals who have been injured by pharmaceuticals. The personal injury attorneys at the firm are available to answer any questions concerning medications, including soliris.
Precautions for Soliris
Soliris blocks terminal complement activation, therefore patients may have increased susceptibility to infections. Aspergillus infections have occurred in immunocompromised and neutropenic patients, that is, patients with low levels of white blood cells that fight infection. Children treated with Soliris may be at increased risk of developing serious infections due to Streptococcus pneumoniae and Haemophilus influenza type b (Hib).
What is Meningococcal Disease?
Meningococcal disease is an infection caused by a strain of bacteria called Neisseria meningitidis. The invasive bacteria is one of the leading causes of bacterial meningitis in children between the ages of 2 and 18 in the United States.
Meningococcal disease may include meningitis – a serious, potentially life-threatening inflammation of the membranes that cover the brain and spinal cord – and/or a life-threatening blood infection. Meningococcal disease may cause loss of a limb through amputation, hearing loss, issues with the nervous system, mental retardation, seizures, and strokes, according to WebMD.
Meningococcal disease is not as contagious as other illnesses, such as the flu or a cold. However, it is spread by contact with infected respiratory and throat secretions. That can happen with coughing, sneezing, or kissing. Because the risk increases with close or prolonged contact with a person that is infected, family members in the same household, caregivers, and college students living in a dormitory, are all at a heightened risk.
FDA’s Black Box Warning
The U.S. Food and Drug Administration (FDA) made the decision to include a black box warning on the drug’s prescribing information for increased risk of meningococcal disease. The “black box” warning is the FDA’s most serious warning.
The Advisory Committee on Immunization Practices (ACIP) advises that all patients receiving eculizumab should also have meningococcal vaccination. Data recently showed that a number of patients receiving eculizumab who were vaccinated with the recommended meningococcal vaccine, still developed meningococcal disease, most often from non-groupable Neisseria meningitidis, which rarely results in invasive disease in healthy people, reports the CDC.
According to WebMD, because the vaccines do not protect against all causes of meningitis, it is still possible that someone could receive the vaccine and still get meningitis from a different strain.
Symptoms of Meningitis
Emergency medical attention should be sought immediately if meningitis symptoms are observed. These symptoms include headache and fever with nausea or vomiting, high fever (103 degrees or higher), body aches, flu symptoms, confusion, increased sensitivity to light, or stiffness in the back or neck.
Through a request for data on meningococcal disease cases reported to state health departments, the U.S. Centers for Disease Control and Prevention (CDC) identified 16 cases of meningococcal disease in individuals who received eculizumab in the United States from 2008 through 2016. Eleven (69 percent) of these were caused by non-groupable N. meningitidis. “Researchers have not assessed the extent of any potential cross protection for non-groupable N. meningitidis strains,” notes the CDC website.
Legal Help for Soliris Users
If you or someone you know have been injured by the use of Soliris, you may have valuable legal rights. The attorneys at Parker Waichman offer free, no-obligation case evaluations. For more information, contact our personal injury lawyers at 1-800-YOURLAWYER (1-800-968-7529).