The boxed warning on the labels of all tumor necrosis factor alpha (TNF-alpha) inhibitors will be updated to warn about the risk for serious and sometimes fatal infection from 2 bacterial pathogens,Legionella and Listeria, the US Food and Drug Administration (FDA) announced today.
TNF-alpha blockers are used to treat rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and juvenile idiopathic arthritis, as well as Crohn's disease and ulcerative colitis. Because they suppress the immune system, these drugs come with a known risk for serious, life-threatening, opportunistic infections, which is a risk previously highlighted in the boxed warning on their labels.
In 2008, the FDA ordered makers of TNF-alpha blockers such as infliximab, adalimumab, and etanercept to strengthen label warnings on the risk for histoplasmosis and other invasive fungal infections.
Today's announcement follows a recent FDA review of bacterial infections in patients treated with TNF-alpha blockers. The agency found reports of 80 patients who developed Legionella pneumonia (also known as Legionnaire's disease) after receiving the drug in its Adverse Events Reporting System from 1999 and 2010. Fourteen patients died. A literature search yield similar results.
Serious and sometimes fatal Listeria infections after TNF-alpha blocker treatment also emerged in a search of the Adverse Events Reporting System and the medical literature.
In addition, spelling out the risk for Legionella and Listeria infection, the FDA is revising the boxed warning for all TNF-alpha blockers so that it contains consistent information about the risk for serious infections and the various pathogens that cause them.
The FDA is advising clinicians to consider the risks and benefits of these drugs in patients who already have a chronic or recurring infection, or who have underlying medical conditions that make them prone to infections. The risk for an opportunistic infection may be higher for patients older than 65 years and for those taking a concomitant immunosuppressant.
Before administering TNF-alpha blockers, and periodically afterward, clinicians should evaluate patients for active tuberculosis and test them for latent infections, according to the agency. Patients also should be monitored for signs and symptoms of serious infection while taking the drug.
More information about today's FDA announcement is available on the agency's Web site.
To report adverse events related to TNF-alpha blockers, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online athttp://www.fda.gov/medwatch, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
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