Wednesday, August 5, 2009

FDA Requires New Warning for TNF Blockers

The FDA announced yesterday that it had completed its review of tumor necrosis factor (TNF) blockers and that it had concluded that there is an increased risk of cancer in children and adolescents who use TNF blockers. The current prescribing information for TNF blockers does contain a warning for malignancies, but it does not specifically mention leukemia. TNF blockers are approved for the treatment of multiple immune system diseases including Crohn’s disease, rheumatoid arthritis, psoriatic arthirtis, plaque psoriasis, and juvenile idiopathic arthritis.

When a person suffers from chronic inflammatory diseases, such as the ones listed above, their body overproduces a protein called tumor necrosis factor-alpha (TNF-a). When this protein exists in large quantities in the body, it can cause inflammation and damage to bones, cartilage, and tissue. When patients suffering from chronic inflammatory diseases take TNF blockers, the drug targets the overproduced TNF-a and neutralizes it. Brand names of TNF blockers include Remicade (infliximab), Enbrel (etancercept), Humira (adalimumab), Cinzia (cetolizumab pegol), and Simponi (golimumab).

The law firm of Schlichter, Bogard & Denton is currently investigating claims against the manufacturers of Remicade, Enbrel, and Humira. If you or a loved one has suffered adverse events from the above mentioned drugs, please contact an experienced pharmaceutical attorney at Schlichter, Bogard & Denton. We serve clients nationwide.

For more information, see the FDA Press Announcement at:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm175803.htm

See the MedWatch Safety Information at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm175843.htm

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posted by Colleen at 8:07 AM

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