FDA issues label change for TNF-alpha blockers to include risk of infection from Legionella and Listeria

September 16, 2011

FDA has notified healthcare professionals that the Boxed Warning for the entire class of Tumor Necrosis Factor-alpha (TNFα) blockers has been updated to include the risk of infection from 2 bacterial pathogens, Legionella and Listeria.

FDA has notified healthcare professionals that the Boxed Warning for the entire class of tumor necrosis factor-alpha (TNF-alpha) blockers has been updated to include the risk of infection from 2 bacterial pathogens, Legionella and Listeria.

This includes label changes for Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab).

In addition, the Boxed Warning and Warnings and Precautions sections of the labels for all of the TNF-alpha blockers have been revised so that they contain consistent information about the risk for serious infections and the associated disease-causing pathogens.

Patients treated with TNF-alpha blockers are at increased risk for developing serious infections involving multiple organ systems and sites that may lead to hospitalization or death due to bacterial, mycobacterial, fungal, viral, parasitic, and other opportunistic pathogens.

The class of TNF-alpha blockers are used to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and/or juvenile idiopathic arthritis.

FDA recommends that the risks and the benefits of TNF-alpha blockers should be considered prior to initiating therapy in patients with chronic or recurrent infection and patients with underlying conditions that may predispose them to infection. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online:
1. www.fda.gov/MedWatch/report.htm
2. Download form or call (800) 332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to (800) FDA-0178.

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm270977.htm