Enbrel Lawsuit

Enbrel (etanercept) is an injection medication used to treat autoimmune diseases. The FDA has approved Enbrel to treat four types of arthritis diseases. It is also approved to treat plaque psoriasis. Our litigation team is currently investigating links between Enbrel and bone fractures, broken bones, and other severe bone injuries. Enbrel has been linked to severe, life-threatening side effects, including several types of cancer, infections, tuberculosis, and more.

Enbrel Overview

Enbrel (etanercept) is an injection medication used in the treatment of five auto-immune system diseases:

• Rheumatoid arthritis
• Plaque psoriasis
• Psoriatic arthritis
• Juvenile idiopathic arthritis
• Ankylosing spondylitis

Enbrel is a genetically engineered Tumor Necrosis Factor (TNF) blocker. TNF is a natural substance created by the body during an auto-immune response. Some people have a chronic condition in which their body creates too much TNF. It causes more white blood cells to move to areas of inflammation, which intensifies the inflammation response.

The active drug in Enbrel binds to the active TNF that is causing an over-active immune response in a person’s body. When the Enbrel molecule binds to TNF, it forces the body to metabolize the TNF, causing the body can flush it out of a patient’s system. This effectively removes excess TNF from the site where it is causing problems and pain, such as joints or skin.

Enbrel Side Effects

Many side effects of Enbrel are related to the fact that it lowers a person’s normal auto-immune response. This can make a person susceptible to developing life-threatening infections, including tuberculosis (TB), viral infections, fungal infections, and bacterial infections. It is recommended that new patients be tested for TB before beginning Enbrel.

Enbrel may be linked to some of the following side effects:

• bone fractures
• bone breaks
• opportunistic fungal infections
• histoplasmosis
• bacterial sepsis
• tuberculosis
• cancer
• lymphoma
• leukemia
• melanoma
• solid organ cancers

Enbrel and Bone Fractures

The Enbrel lawyers at The Schmidt Firm, PLLC are currently investigating links between Enbrel and bone fractures. If you suffered a bone fracture while taking Enbrel, contact us today for a free case consultation. Other types of musculoskeletal side effects include joint pain, back pain, infective arthritis. There has been at least one case of septic arthritis due to a bacterial infection with Listeria monocytogenes.

Symptoms of a broken bone include:

• Swelling, redness, bruising over the site of the break
• Abnormal appearance over the broken bone
• Severe pain that worsens when the bone is moved
• Loss of function
• In compound fractures, the bone may protrude outside the body

Enbrel and Cancer

The safety labeling on Enbrel already warns that adults who take this medications may have a greater risk of developing lymphoma, leukemia (cancer of the white blood cells), skin cancer, and other types of cancer. However, the U.S. Food and Drug Administration (FDA) has also received numerous reports of children developing cancer. The FDA received dozens of reports of cancer in children, which prompted the FDA to require drug companies that manufacture TNF-blocking medications to warn about the risk of cancer.

Enbrel FDA Warning

The first FDA warning regarding Enbrel came in November 2008. Although the safety labeling on Enbrel contained information about the risk of infection, it did not warn about histoplasmosis and invasive fungal infections. This caused treatment to be delayed. In September 2008, the FDA received 21 reports of people who had suffered fungal infections that were not immediately treated. 12 of those patients died from the infection.

The second FDA warning came 2011, when the FDA received numerous reports of cancer in children and young adults taking TNF-blockers such as Enbrel. The FDA warned that manufacturers of TNF-blockers, including Enbrel, will be subject to enhanced safety surveillance after the FDA received numerous reports of cancer linked to children taking the medication. The FDA will require the manufacturers to submit reports to the FDA within 15 days of receiving them. Furthermore, the manufacturers will also be forced to provide the FDA with annual summaries of adverse event reports that they receive from consumers.

It is possible that this data will include side effects in addition to cancer, such as bone fractures, opportunistic fungal infections, bacterial infections, and more. This type of safety surveillance helps health authorities improve their understanding of what types of side effects medications are causing when they are used in the general population.

If you took Enbrel and were diagnosed with a serious side effect, the Enbrel lawyers at The Schmidt Firm, PLLC encourage you to help the FDA conduct its review by submitting your report to the FDA’s MedWatch program. We also encourage you to contact us. We may be able to help you receive compensation for your injury by filing an Enbrel lawsuit.