Enbrel (generic: etanercept) is an FDA-approved prescription medication used for the treatment of arthritis and plaque psoriasis. Our law firm is currently investigating the link between Enbrel and bone fractures, bone breaks and other serious enbrel-induced bone side effects. In addition to these types of injuries, Enbrel has also been linked to a variety of other serious complications including fungal and bacterial infections, tuberculosis, and cancer.
What is Enbrel?
Manufactured by Immunex Corporation, and jointly marketed by Amgen and Pfizer, Enbrel (generic: etanercept) is a tumor necrosis factor alpha blocker that is designed to suppress the patient’s immune system. The immune system helps the body fight infections. In people with autoimmune disorders, the immune system mistakes the body’s own cells for invaders and attacks them. Enbrel is commonly prescribed to treat a variety of conditions including:
- moderate to severe rheumatoid arthritis
- moderate to severe polyarticular juvenile idiopathic arthritis (formerly called juvenile rheumatoid arthritis)
- psoriatic arthritis
- ankylosing spondylitis
- moderate to severe plaque psoriasis
Enbrel Side Effects
Enbrel may be linked to some of the following side effects:
- Bone fractures
- Bone breaks
- Opportunistic fungal infections
- Bacterial sepsis
- Solid organ cancers
- Blood reactions
- Multiple Sclerosis
- Optic Neuritis
- Aplastic Anemia
- Hepatitis B
Enbrel and Bone Fractures
Enbrel may be linked to a number of musculoskeletal side effects including bone fractures, joint pain and accelerated nodulosis. Back pain and infective arthritis have also been reported in Enbrel users. Additionally, at least one case of septic arthritis due to Listeria monocytogenes has been reportedly linked to Enbrel.
Bone fractures resulting from Enbrel use have the potential to be complicated by damage to nearby blood vessels, nerves, muscles and joints. Signs and symptoms of an Enbrel-induced bone fracture may include:
- a visibly out-of-place or misshapen limb or joint
- swelling, bruising, or bleeding
- intense pain
- numbness and tingling
- broken skin with bone protruding
- limited mobility
- inability to move a limb
Enbrel and Cancer
The FDA is currently investigating the link between Enbrel and the development of lymphoma and other types of cancer in children and young adults. In June 2008, the administration reported that it was investigating approximately 30 cases of cancer in children and young adults who used TNF blockers. Cancers reportedly associated with Enbrel include lymphoma, leukemia, melanoma and solid organ cancers. The FDA has required that makers of TNF blockers warn users about the inherent risk of cancer associated with their medications.
Enbrel FDA Warning
In November 2008, the U.S. Food & Drug Administration (FDA) required that Enbrel labels be updated to include a warning about the risk of users developing opportunistic fungal infections. Although the warning label had previously included information about the risk of serious infections, cases of histoplasmosis and other invasive fungal infections were not recognized consistently, resulting in a delay in treatment. As of September 2008, at least 21 reports of fungal infection were not treated immediately and, of those, 12 patients died.
Signs and symptoms of Enbrel-induced systemic fungal infections include:
- persistent fever
- weight loss
- shortness of breath
Enbrel users who begin noticing any of these symptoms should seek immediate medical attention.
Before Taking Enbrel
Do not take Enbrel if you are allergic to etanercept, or if you have a severe infection such as sepsis. Some users have reported developing a rare, potentially-fatal type of lymphoma that affects the liver, spleen and bone marrow. This disease is typically found in teenagers and young adults using Enbrel to treat Crohn’s disease or ulcerative colitis. However, individuals with autoimmune disorders tend to have an increased risk of lymphoma.
Consult your healthcare professional before taking Enbrel if you have any of the following conditions:
- a weak immune system
- skin infection
- open sores
- congestive heart failure
- a nerve disorder
- multiple sclerosis
- optic neuritis
- epilepsy or other seizure disorder
- asthma or other breathing disorder
- hepatitis B
- if you are allergic to latex rubber
- if you are scheduled to receive any vaccines
- if you have recently been vaccinated with BCG (Bacille Calmette-Guerin)
Enbrel and Pregnancy
The FDA currently classifies Enbrel in Pregnancy Category B, which means that it is not expected to harm an unborn baby. Consult your physician if you are pregnant or planning to become pregnant while taking Enbrel. Since it is not known whether Enbrel has the ability to pass into breast milk, do not use Enbrel without telling your doctor if you are breast-feeding a baby. Additionally, children taking Enbrel should be current on all childhood immunizations before beginning a regimen of the medication.