Humira, Enbrel, Remicade, Other TNFa Blockers Get Black Box Warning for Legionella, Listeria

The U.S. Food & Drug Administration (FDA) announced yesterday that information about Legionella and Listeria infections has been added to the Black Box warning label for all Tumor Necrosis Factor-alpha (TNFa) blockers. TNFa blockers, which suppress the immune system, include the drugs <"">Remicade (infliximab), <"">Enbrel (etanercept), <"">Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab).

According to an FDA Drug Safety Communication issued yesterday afternoon, there have been more than 100 reports of Legionella and Listeria infections associated with TNFa blockers. Between 1999 and 2009, the FDA’s Adverse Event Reporting System (AERS) database received 80 reports of people who developed Legionella pneumonia after having received Remicade, Enbrel, Humira, and Simponi. Fourteen deaths were reported among that group.

Another 23 cases of Legionella infection were identified in the medical literature that involved people who had received TNFa blockers for rheumatologic disorders, inflammatory bowel disease, and psoriasis. Those patients had received Remicade, Humira, and Enbrel, according to the FDA. There were three deaths in that group, and in one case, Legionella returned when the patient resumed treatment with a TNFa blocker.

Twenty-six cases of Listeria, including seven deaths, have also been reported in the medical literature among patients treated with TNFa blockers, the FDA said. Fatal Listeria infections were also reported during pre-marketing phase 2 and phase 3 clinical trials and from post-marketing surveillance of the drugs.

In many cases, the FDA said patients infected with either Legionella or Listeria were also undergoing therapy with other immunosuppressant drugs, such as methotrexate and/or corticosteroids

“The risks and the benefits of the 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,” the FDA wrote.

The FDA also advised that the risk of these infections may be greater in patients over 65, or those taking other immunosuppressive therapies. Patients should be evaluated for active tuberculosis and tested for latent infection prior to initiating treatment with TNFa blockers, the FDA said.

Remicade, Enbrel, Humira, Cimzia, and Simponi are used to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and/or juvenile idiopathic arthritis. Because they suppress the immune system, people treated with TNFa blockers face an increased risk of developing serious infections.

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