In the News / Politics:

In The News: TNF-Alpha Inhibitors Receive More Warnings

By Ebey P. Soman

TNF-alpha inhibitors are drugs used to treat rheumatoid arthritis, Crohn’s disease, and ulcerative colitis, as well as other disease states. These agents suppress the immune system and increase the risk of developing serious infections.

Currently, there are five approved drugs in this category:
• Adalimumab (Humira®, Abbott)
• Certolizumab pegol (Cimzia®, UCB)
• Etanercept (Enbrel®, Amgen/Pfizer)
• Golumumab (Simponi®, Janssen)
• Infliximab (Remicade®, Janssen)

Specific bacteria have been identified as opportunistic pathogens in patients who are treated with TNF-alpha inhibitors. These include mycobacteria (causing tuberculosis or TB), hepatitis B (and other viruses), and fungi (causing aspergillosis, candidiasis, and pneumocystosis). The US Food and Drug Ad-ministration (FDA) asked manufacturers of these medications to provide boxed warnings for the risk of infections. In 2008, it warned of the risk for histoplasmosis and other invasive fungal infections associated with the use of TNF-alpha inhibitors. The FDA then asked manufacturers to also add this information to the boxed warnings.

Now, the FDA is asking makers of TNF-alpha inhibitors to add two more fatal bacterial infections to the list. The announcement came after a retrospective analysis of the FDA‟s Adverse Event Reporting System (AERS) on bacterial infections in patients who were treated with TNF-alpha inhibitors with or without another immunosuppressant. From 1999 to 2010, the FDA found case reports of patients developing Legionella pneumophila (the cause of legionellosis or Legionnaire’s dis-ease) after receiving these drugs. Another AERS review, along with post marketing surveillance data of these drugs, revealed a prevalence of Listeria infections. The FDA also ordered the boxed warnings to provide consistent information with all pathogens listed to enable healthcare providers to identify and treat these patients before they develop further complications.

The FDA is advising physicians, pharmacists, and other healthcare professionals to weigh the risks and benefits of this therapy. Patients with the highest risk of developing drug-induced complications or infections are the elderly (> 65 years of age) and those taking concomitant immunosuppressants. Among other infections, patients should be tested for latent and active TB, as it is possible to develop TB even after testing negative for a latent infection. Due to these concerns, medical professionals are encouraged to continue monitoring patients after discontinuation of treatment.


Published by Rho Chi Post
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