FDA adds Legionella & Listeria to TNFa blocker label warning

Tumor necrosis factor alpha (TNFa) blockers – prescribed to treat autoimmune disorders such as rheumatoid arthritis and Crohn’s disease – work by suppressing the immune system’s attack on ‘self’, but also lower resistance to many opportunistic pathogens.

Now, based on some 100 case reports, the FDA has added the bacterial infections Legionella (contracted by inhalation of airborne water droplets, as in a form of pneumonia dubbed Legionnaire’s disease) and Listeria (food borne) infections to the already lengthy “Boxed Warning” for these drugs.

Five FDA-approved TNFa blockers are currently available in the US, according to the FDA press release of Sep 7:
• Remicade (infliximab),
• Enbrel (etanercept),
• Humira (adalimumab),
• Cimzia (certolizumab pegol),
• And Simponi (golimumab).

The FDA urges people using a TNFa blocker – or any drug – to report serious side effects or safety problems to the FDA MedWatch program here (https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm) or by calling 1-800-332-1088.

For the full FDA press release on risks associated with using TNFa, click here: http://www.fda.gov/Drugs/DrugSafety/ucm270849.htm.

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