Nov
30
2011
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Tumor necrosis factor-alpha (TNFα) inhibitors have received a new boxed warning from the Food and Drug Administration that indicates a heightened risk of infection by legionella bacteria in patients treating with the drugs.

The TNFα inhibitors permitted in the United States include infliximab (Remicade), adalimumab (Humira), etanercept (Enbrel), and golimubab (Simponi), and are used to treat certain types of arthritis and psoriasis, among other conditions.

Eighty cases of Legionnaires’ disease, occurring between 1999 and 2010, were reported to the FDA’s Adverse Event Reporting System (AERS) among patients receiving TNFα inhibitors; of these, 14 died.  Patients ranged in age from 25 to 85 years.

The FDA advises medical providers to weigh the risks and benefits before administering these drugs, especially in patients with pre-existing conditions associated with immunosuppresion.

Sources:

http://www.gastroendonews.com/ViewArticle.aspx?d=FDA+Update+&+Product+News&d_id=183&i=November+2011&i_id=789&a_id=19725

http://www.medpagetoday.com/ProductAlert/Prescriptions/28396

Posted by jzacher">jzacher at 3:52 pm
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