Remicade 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.
Remicade Lawsuit Information
Remicade (Inflixamab) is an autoimmune suppressant that was approved by the FDA in 1998 for the treatment of rheumatoid arthritis, Crohn's disease, ulcerative colitis and other diseases. It is the second medication approved by the FDA that blocks a protein called tumor necrosis factor (TNF). Excess amounts of TNF in the body can contribute to the onset of these diseases or contribute to their severity.
TNF is, however, present in the human body as a component of the autoimmune system. Blocking its function or reducing its level can contribute to the development of other ailments, especially infectious diseases. For Remicade and other TNF blockers, there is in particular an increased risk for the development of tuberculosis.
There have been reports of patients using Remicade developing malignancies, in particular an aggressive malignancy called lymphoma. The FDA recognizes the history of serious side effects for Remicade and other TNF blockers, but continues to approve their use. In 2006 Remicade was approved for use by children who suffer from Crohn's disease. The drug is administered through a slow infusion process that is repeated after a period of weeks. Patients have reported infusion reactions that include hives, difficulty breathing, sinusitis and upper respiratory infections.
Also in 2006 there was an article in the Journal of the American Medical Association about a study conducted at the Mayo clinic concerning the relationship of TNF blockers to the development of cancer. The study involved Remicade and one other TNF blocker, and in their results the researchers cited an increased rate of several types of cancer and of serious infection. They also suggested, however, that anti-TNF treatment may simply accelerate the detection of preexisting cancer rather than induce new malignancy.
FDA Investigation
In June of 2008 the FDA announced that it was investigating a potential relationship between Remicade and other TNF blockers, to the development of malignancies in children and young adults. They have requested reports on all such developments from the makers of TNF blockers that have been approved for children. The study will be showing no immediate results, however, as it is scheduled to take ten years to complete.
The issue with continuing reports of serious side effects from Remicade and similar medications is the question of treatment value versus risk. Neither the FDA nor the drug manufacturers are prepared to suggest that the risks outweigh the benefits for TNF blockers when taken by children or young adults. However the instances of fatality for both children and adults using Remicade are causing questions among consumers, many of whom have filed liability claims against the manufacturer.
