FDA requires label changes

FDA requires label changes for Tumor Necrosis Factor blockers for Rheumatoid Arthritis and Crohn's based on infection risks

A variety of “high tech” medicines work to block the action of tumor necrosis factor. This is important because this helps control Rheumatoid Arthritis (RA), psoriatic arthritis, ankylosing  spondylitis, plaque psoriasis, juvenile idiopathic arthritis, ulcerative colitis and Crohn’s disease. It’s essential to understand that these medicines work by blunting part of the response of the immune system.

The FDA has required Cimzia (certolizumab pegol), Embrel (etanercept), Humira (adalimumab) and Remicade (infliximab) to change their official medicine labels to include a black box warning about increased risk of infection from two specific bacteria named Legionella and Listeria.

The FDA continued in warning that patients treated with this class of medicines are at risk for serious infections of multiple organs by bacterial, mycobacterial, fungal, viral, parasitic and other opportunistic pathogens which may lead to hospitalization or death.

What this means now more than ever is that there is a serious consideration of benefit to risk which must be given prior to starting treatment, especially in people with ongoing or recurrent infection as well as in patients who have underlying conditions that may put them at risk of infection.

As always, patients and healthcare professionals can report adverse events or side effects atwww.fda.gov/MedWatch/report.htm.

Visit the FDA at www.fda.gov for more information and talk to your doctor about these or any other medicines. 

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