title: Brief communication: characteristics of spontaneous cases of tuberculosis associated with infliximab.
abstract: BACKGROUND
  A warning for tuberculosis was added to the approved labeling for infliximab in October 2001.
  
  
  OBJECTIVE
  To describe adverse event reports of tuberculosis during infliximab therapy after labeling changes.
  
  
  METHODS
  Case series.
  
  
  METHODS
  Spontaneous adverse event reports maintained in the Adverse Event Reporting System database in the United States.
  
  
  METHODS
  130 patients with infliximab-associated tuberculosis.
  
  
  METHODS
  Clinical and laboratory data.
  
  
  RESULTS
  The U.S. Food and Drug Administration received 130 domestic, spontaneous reports of tuberculosis in patients treated with infliximab between 1 November 2001 and 30 May 2006, including 59 (45%) with extrapulmonary disease. The most commonly reported risk factors included concomitant immunosuppressant use (n = 89), history of latent or active tuberculosis (n = 33), and being born into or having spent extensive time in an area where tuberculosis is endemic (n = 25). In the subset of 67 cases with documented initiation of infliximab therapy after the drug labeling change, 34 patients with a negative tuberculin skin test result before initiation of infliximab therapy developed tuberculosis after receiving infliximab.
  
  
  CONCLUSIONS
  Conclusions from spontaneous case reports may not be generalizable to the entire infliximab-receiving population.
  
  
  CONCLUSIONS
  Clinicians should be vigilant in screening and monitoring for tuberculosis in patients receiving infliximab.
authors.affiliation: U. S. Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: Angela
authors.initials: A
authors.lastname: Raval
authors.forename: Gita
authors.initials: G
authors.lastname: Akhavan-Toyserkani
authors.forename: Allen
authors.initials: A
authors.lastname: Brinker
authors.forename: Mark
authors.initials: M
authors.lastname: Avigan
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000009:adverse effects*; D000911:Antibodies, Monoclonal / Q000009:adverse effects*; D005188:False Negative Reactions; D005260:Female; D006801:Humans; D016867:Immunocompromised Host; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D014374:Tuberculin Test; D014376:Tuberculosis / Q000175:diagnosis / Q000209:etiology* / Q000276:immunology; D014481:United States
chemical_list: D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D000069285:Infliximab