Enbrel Black Box Warning

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Enbrel is manufactured by Immunex Corporation and marketed in the US by Amgen and Wyeth Pharmaceuticals.  

Enbrel is a drug that is used to treat many types of autoimmune diseases, also used for children with arthritis. It works by interfering with the TNF receptor and acts as a TNF inhibitor.

Immunex Corporation has stated on their website “Serious infections have happened in patients taking ENBREL. These infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some patients have died from these infections. Your doctor should test you for TB before you take ENBREL and monitor you closely for TB while on ENBREL.”


Enbrel Black Box Warning for Increased Risk of Cancer.

The FDA has published information on the FDA.gov site and states the following:

FDA has asked the makers of the TNF blockers approved for use in children (Remicade, Enbrel, and Humira) to provide information about all cases of cancer reported in children taking TNF blockers.  The maker of Cimzia is required to conduct a study to assess long-term risks of the product, including lymphoma and other cancers.  This study will begin in 2009 and take about 10 years to complete.  FDA has contacted medical experts to assess the potential association between TNF blockers and cancers, including lymphoma, and to determine if there are children and young adults with JIA and Crohn’s disease who may be at particular risk for developing a lymphoma or other cancer.

The FDA has also noted that there is an increase the risk of cancer after the drugs were used for longer than two and a half years.


Enbrel Side Effects Include:

Respiratory side effects
Immunologic side effects
Nervous system side effects
Gastrointestinal side effects
Cardiovascular side effects
Oncologic side effects

If you or someone you know has been diagnosed with any type of cancer and believe that it’s from using Enbrel, contact us today by using the contact form. There may be a class action lawsuit starting with possible cash settlements for victims.

Enbrel Multiple-Use Vials
Enbrel Prefilled Syringes

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Information on Enbrel FDA Black Box Warning updated 3/06/2013