Labels for TNF-alpha blockers to warn of potential for infection

In a safety communication released September 7, 2011, FDA announced it is requiring the prescribing information for all tumor necrosis factor-alpha blockers to include a black-boxed warning regarding an increased risk of infection from 2 bacterial pathogens, Legionella and Listeria.

Key Points

In a safety communication released September 7, 2011, FDA announced it is requiring the prescribing information for all tumor necrosis factor (TNF)-alpha blockers to include a black-boxed warning regarding an increased risk of infection from 2 bacterial pathogens, Legionella and Listeria. Each of these biologic agents suppress patients' immune systems, and consequently, increase the risk of serious and potentially fatal bacterial, mycobacterial, fungal, parasitic, and viral infections.

Currently, a number of TNF-alpha blockers have marketing approval in the United States including infliximab (Remicade), etanercept (Enbrel), adalimumab (Humira), certolizumab pegol (Cimzia), and golimumab (Simponi). These agents are approved for a host of different indications such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and juvenile idiopathic arthritis. The first of these agents was approved by FDA back in 1998.

The decision to include Legionella infection in the prescribing information of TNF-alpha blockers comes after FDA's review of the Adverse Event Reporting System (AERS) database through 2010. The agency's search identified 80 reports of patients developing Legionella pneumonia (30 of which were confirmed by laboratory analysis) after receiving a TNF-alpha inhibitor. Fourteen of these cases were ultimately fatal. Patients developing Legionella were between 25 and 85 years of age, 65% had a diagnosis of rheumatoid arthritis, and the median duration of TNF-alpha blocker administration prior to onset of Legionella infection was about 10 months. Of note, many of these patients were receiving concomitant immunosuppressant therapy. FDA also identified published case reports describing an additional 23 cases of Legionella pneumonia resulting from TNF-alpha blocker use.

Along with these new warnings, agency officials are recommending prescribers weigh both the risks and the benefits of TNF-alpha blockers prior to initiating therapy; particularly in patients with chronic or recurrent infection and in patients with underlying conditions that may predispose them to infection. FDA also suggests patients be monitored closely for signs and symptoms of serious infections while on therapy.

SOURCE

FDA. FDA Drug Safety Communication: Drug labels for the Tumor Necrosis Factor-alpha (TNFa) blockers now include warnings about infection with Legionella and Listeria bacteria [Posted 09/7/2011]. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm270849.htm. Accessed September 17, 2011.

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