Humira Lawsuit
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NEW WARNING!!!
August 7, 2009
FDA Releases Report on TNF Blockers
The FDA has completed an analysis of possible side effects caused by a class of drugs known as TNF blockers. These medications include Remicade, Enbrel, Humira, Cimzia, and Simponi. The FDA has concluded that there is an increased risk of lymphoma and other cancers in children and adolescents who are given these medications.
Humira Lawsuit Information
Humira (adalimumab) is a medication developed by Abbott Laboratories that is used to treat rheumatoid arthritis, psoriatic arthritis, Crone's disease and juvenile arthritis. It is an autoimmune suppressant that acts to block or reduce the effect of tumor necrosis factor (TNF), a protein produced by the body that is a component of the immune system.
Humira was approved by the FDA in 2002 for treatment of arthritis specifically in patients that have not responded to other types of treatments for their illness. In 2007 it was approved for the treatment of Crone's disease, also for patients who have not responded to treatment with other medications, including a similar autoimmune suppressant from Johnson & Johnson, Remicade.
FDA Approval and Warning
These medications are both TNF blockers. Along with similar drugs, Humira carries warnings in its packaging that caution against use by patients with a history of recurrent infections. In its announcement approving use for Crone's the FDA stated, "The labeling of Humira includes a boxed warning, the strongest type of label warning, that use of this product has been associated with serious, sometimes fatal, infections, including cases of tuberculosis, opportunistic infections, and sepsis. Before initiating Humira treatment, patients should be evaluated for tuberculosis risk factors and tested for latent tuberculosis infection. Other serious adverse events reported by Humira users include lymphoma, a type of cancer. The most frequent adverse events included upper respiratory infections, sinusitis, and nausea."
Autoimmune suppressants all carry the risk of increased vulnerability to other diseases. Humira and other TNF blockers including Remicade and Enbrel all have shown some relationship to the development of tuberculosis and the onset of lymphoma. While the number of serious side effects among the patient population has not yet caused any recalls, the similarity of weaknesses among all TNF blockers is startling.
As with all drugs, the FDA weighs the value of treatment with Humira against the risks associated with use of the medication. Humira is used for treatment of patients with sustained, serious ailments that indicate, to some degree, a compromised state of health centered in the immune system. The fact that TNF blockers further compromise the immune system while treating a disease caused by autoimmune malfunction suggests that measuring the balance between efficacy and risk should be a cautious and precise process.
