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Published: August 29th, 2008
The arthritis drug Enbrel has been linked to an increased risk of fatal infections, incluing tuberculosis and fungal infections. In May 2008, a “black box” warning was added about the risk of tuberculosis. In September 2008, the FDA added information to the “black box” warning about the risk of potentially fatal fungal infections, which were often going undiagnosed.
STATUS OF ENBREL LAWSUITS: Potential for legal claims are being evaluated for individuals diagnosed with tuberculosis before May 1, 2008 or who died as a result of an infection.
MANUFACTURERS: Amgen, Inc. and Wyeth
OVERVIEW: Enbrel (etanercept) is a Tumor Necrosis Factor (TNF) Blocker, which was approved in 1998 to treat various auto immune disorders, such as Crohn’s disease, rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and juvenile idopathic arthritis (previously known as juvenile rheumatoid arthritis). It is administered as an injection given either by the user or a caregiver.
There are three other TNF blockers currently approved in the United States, Remicade, Humira and Cimzia. When all uses are considered, including indications that Remicade is not approved for, Enbrel is the most widely useed TNF blocker.
ENBREL TUBERCULOSIS RISK: In May 1999, information was added to the warning label about a possible risk of serious infections, including sepsis, which has caused a number of deaths. In April 2008, this information was added to a “black box” which was more prominently displayed on the label.
The “black box” warning also included information about cases of tuberculosis associated with use of Enbrel injections. The FDA and manufacturers indicated that healthcare providers should screen their patients for latent tuberculosis before prescribing Enbrel.
Tuberculosis, also known as tubercle bacillus or TB, is a deadly infection which commonly attacks the lungs (pulmonary TB), the central nervous system, circulatory system, bones, joints or the skin.
Symptoms of tuberculosis could include:
- Chest Pain
- Coughing Blood
- Fever, Chills or Night Sweats
- Appetite Loss or Weight Loss
ENBREL CANCER SIDE EFFECTS: In June 2008, the FDA released an early communication about an ongoing safety review involving Enbrel and a possible association with the development of lymphoma and other cancers among children and young adults and an Enbrel black box cancer warning was added in August 2009.
Approximately half of the cancers seen in all children and young adults taking TNF blockers were lymphomas, including bother Hodgkin’s and non-Hodgkin’s lymphoma, which is a cancer of cells in the immune system. Lymphoma is not a recognized complication of JIA (Juvenile Idiopathic Arthritis) or of Crohn’s disease. Other cancers reported included leukemia, melanoma and solid organ cancers.
ENBRAL FUNGAL INFECTIONS: A number of users who were receiving TNF blockers, such as Enbrel, have experienced fungal infections, such as histoplasmosis, blastomycosis and cocciioidmycosis. In several of these cases the infection resulted in death.
In September 2008, the FDA issued an alert to healthcare providers to provide new information about the risk of Enbrel fungal infections. At that time the agency also indicated that new information will be added to the Enbrel black box warning to ensure that doctors and consumers are aware of the risk, especially for those who live in or visit areas where fungus is prevalent.
Unfortunately, many cases of fungal infections from Enbrel go undiagnosed by doctors, since the symptoms are similar to the flu. Symptoms could include cough, fever, fatigue, loss of weight, sweating and shortness of breath.