Enbrel Side Effects Lawsuit
Enbrel Side Effects
According to a public health alert issued by the FDA in April 2011, use of popular arthritis drug Enbrel can lead to blood cancer. Enbrel, trade name of Etanercept, is a TNF inhibitor co-marketed by Pfizer and Amgen in North America. Available in both powder and premixed liquid form, it was one of the most sold drugs in the U.S. market in 2010 with sales exceeding $3 billion. Enbrel is known to treat autoimmune disorders, such as plaque psoriasis, rheumatoid and psoriatic arthritis, excessive inflammation, and ankylosing spondylitis, in adults and prevent damages to joints caused by these diseases. It helps in the treatment of juvenile rheumatoid and polyarticular idiopathic arthritis in children above 2 years of age.
The immune system mistakenly attacks and destroys its own cells in people suffering from autoimmune problems. Enbrel prevents this by reducing the production of a certain protein that helps the immune system fight invaders. However, such action by the drug leads to serious and fatal side effects. The decrease in the number of white blood cells caused by the drug puts patients at a great risk of fatal infections. Teenagers and young adults with ulcerative colitis are likely to develop a rare, fatal cancer, which affects the liver, lymph, bone marrow, and spleen. Enbrel has also been linked to night sweats, loss of appetite, breathing problems, rapid heart rate, jaundice, and
other serious adverse reactions in patients.
FDA Enbrel Warning
The FDA approved the drug in November 1998 to treat rheumatoid arthritis in both adult and juvenile patients. But a spurt in serious infections, including sepsis, in Enbrel users prompted the federal regulator to issue a public health alert in May 1999. The FDA asked the manufacturer to study the possible link between the infections and the drug. The drug is linked to six deaths and 30 cases of fatal infections. In January 2002, the FDA warned both patients and healthcare professionals about possible nervous system side effects of Enbrel. A month later, a study discovered that four Chicago women with rheumatoid arthritis suffered from systemic lupus erythematosus symptoms, such as face reddening, skin lesions, fever, body rash, fatigue, and joint pains after taking the Enbrel.
In March 2003, the FDA first alerted about the possibility of incurable lymph cancer in arthritis patients caused by three TNF inhibitors, including Enbrel. In February 2005, it ordered Amgen to withdraw a television ad on the effectiveness of Enbrel for treating psoriasis. The federal regulator dismissed the claim by the manufacture that the drug helped in the complete healing of psoriatic skin. Two months later, Dutch researchers found that Enbrel and other arthritis drugs were responsible for a number of skin problems in rheumatoid patients. The report published in the Journal Arthritis Research and Therapy cited several cases of significant dermatological adverse conditions, such as drug-related skin eruptions, infections, and eczema caused by the TNF-blocking drugs. According to another study published by the School of Medicine at the University of Kansas in August 2007, arthritis drugs, such as Enbrel, marginally increase the risk of skin cancer.
In March 2008, the FDA added a black box warning highlighting the risk of tuberculosis, bacterial sepsis, and other serious infections caused by the drug. In June 2008, the FDA ordered for a comprehensive review of Enbrel side effects following reports by its Adverse Event Reporting System that around 30 children developed melanoma, lymphomas, leukemia, and solid organ cancers, between 1998 and 2008 due to the side effects of Enbrel and two other drugs of the same class, Remicade and Humira. In September 2008, the federal regulator updated the black box label to include the risk of fatal fungal infections. The action came after it received 240 reports of histoplasmosis, a respiratory fungal infection, in Enbrel users. The FDA released another black box warning on the drug to include lymph cancer risk for kids and young users in August 2009.
Enbrel Side Effects
Allergic reactions: Some individuals might experience allergic reactions due to Enbrel administration. Swollen face or throat, severe rash, and breathing problems are some of the signs of allergic reaction in some individuals. This happens mostly in those cases where patients are allergic to rubber or latex, as it is dry natural rubber that makes the needle cover on the prefilled Enbrel syringe.
Cancer or Lymphoma: Cancer is also reported to be one of the Enbrel side effects. Some reports link etanercept and similar medications with lymphoma. In most cases, patients suffering from rheumatoid arthritis or psoriasis are at a high risk of developing lymphoma due to the intake of medications suppressing the immune system, such as Enbrel.
Blood disorders: In rare cases, Enbrel administration has caused deficiency of some type of blood cells. Such patients might experience black tarry stools, blood in the stools, easy bruising, blood in the vomit, and look pale and restless.
Heart failure: Rarely, the drug is known to worsen the condition of congestive heart failure in some patients, who might experience shortness of breath, swollen ankles and feet.
Infections: In some cases, the drug has been reported to have caused serious infections, including tuberculosis, sepsis. If the medication is used in combination with other drugs, including anakinra, abatacept, Echinacea, cyclophosphamide, live vaccines, and sulfasalazine, it poses the risk of severe infection.
Hepatitis B: The medication is also feared to cause a relapse of hepatitis B infection, which damages the liver. The patient experiences liver problems, including abdominal pain, fatigue, loss of appetite, yellow eyes or skin.
Nervous system: In rare cases, Enbre has been linked to nervous system disorders, including dizziness, vision changes, numb or tingling, weakness in legs or arms.
Common Side Effects of Enbrel
Infection, such as sinus, common cold, irritated or runny nose, cough, chills, fever, and sore throat
Injection site reactions, including swelling, unexplained rash, pale skin, redness, itching, hives
- Dizziness and vomiting
- Mouth ulcers
- Chest pain
- Difficulty breathing
- Unusual bleeding
- Swollen lymph nodes
Some of the rare side effects of the drug include pneumonia, congestive heart failure, cellulitis, kidney infection, blood clot in the lungs, Appendicitis, Osteomyelitis, kidney stones, and inflammatory bowel disease such as ulcerative colitis or Crohn's disease.