The existing boxed warnings on all tumor necrosis factor-alpha inhibiting drugs will be updated to reflect risk for infection with the bacteria Legionella and Listeria, the FDA announced.
These pathogens have caused more than 100 infections in people taking TNF-alpha blockers including infliximab (Remicade), etanercept (Enbrel), adalimumab (Humira), certolizumab pegol (Cimzia) and golimumab (Simponi).
“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 in a drug safety communication.
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TNF-alpha inhibitors are used to treat patients with Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis and/or juvenile idiopathic arthritis.
Serious infections with bacterial, mycobacterial, fungal, viral, parasitic and other opportunistic pathogens are a known risk factor associated with this class of drugs.
Between 1999 and 2010, the FDA received reports of 80 cases of Legionella pneumonia and 14 deaths after patients took a TNF-alpha inhibitor, most commonly for rheumatoid arthritis.
Median TNF-alpha inhibitor treatment lasted for 10.4 months, with infections occurring as early as one month and as late as 73 months after initiating treatment. Many reported cases involved concurrent treatment with methotrexate and corticosteroids.
The FDA has also received reports of 26 cases of serious Listeria monocytogenes infection, encompassing meningitis, endophthalmitis, bacteremia and sepsis among patients taking TNF-alpha inhibitors. There were seven deaths. Additional cases of Listeria are also occurring in clinical trials of the drugs, the agency warned.
Clinicians should monitor patients taking TNF-alpha inhibitors for signs and symptoms of serious infection and should report any adverse events associated with the medication to the MedWatch Safety Database. Patients older than 65 years are at increased risk for infection, the FDA warned.
