title: Alleged isotretinoin-associated inflammatory bowel disease: disproportionate reporting by attorneys to the Food and Drug Administration Adverse Event Reporting System.
abstract: BACKGROUND
  Some studies have purported to link isotretinoin prescribed for acne with the development of inflammatory bowel disease (IBD).
  
  
  OBJECTIVE
  We sought to identify existence of disproportionate attorney-initiated reporting of isotretinoin-associated IBD in the Food and Drug Administration Adverse Event Reporting System (FAERS).
  
  
  METHODS
  A total of 3,338,835 cases (2003-2011) were downloaded from the FAERS. These were queried for IBD cases reported with isotretinoin for a usage indication of acne while recording reporter category. Trends were analyzed over time for reports by attorneys for all medications compared with reports of IBD with isotretinoin. Signal inflation factor was calculated to determine the distortion of pharmacovigilance signals for IBD with isotretinoin.
  
  
  RESULTS
  There were 2214 cases of IBD resulting from isotretinoin. Attorneys reported 1944 (87.8%) cases whereas physicians reported 132 (6.0%) and consumers reported 112 (5.1%) cases (P value < .01). For the entire FAERS, only 87,905 of the total 2,451,314 (3.6%) reports for all drug reactions during the same time period were reported by attorneys (P value < .01). The signal inflation factor for IBD with isotretinoin for attorney-initiated reports was 5.82, signifying a clear distortion.
  
  
  CONCLUSIONS
  The accuracy of reports was not ascertained.
  
  
  CONCLUSIONS
  Attorney-initiated reports inflate the pharmacovigilance signal of isotretinoin-associated IBD in the FAERS.
authors.affiliation: Center for Study of Complex Diseases, Research Institute, Evanston, and Gastroenterology Department, Highland Park, NorthShore University HealthSystem, Illinois, USA.
authors.forename: Derrick J
authors.initials: DJ
authors.lastname: Stobaugh
authors.forename: Parakkal
authors.initials: P
authors.lastname: Deepak
authors.forename: Eli D
authors.initials: ED
authors.lastname: Ehrenpreis
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy; D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D003879:Dermatologic Agents / Q000009:adverse effects*; D005260:Female; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000139:chemically induced*; D015474:Isotretinoin / Q000009:adverse effects*; D007603:Jurisprudence; D033241:Lawyers; D008297:Male; D060735:Pharmacovigilance; D014481:United States; D014486:United States Food and Drug Administration; D055815:Young Adult
chemical_list: D003879:Dermatologic Agents; D015474:Isotretinoin
keywords: FAERS; FDA; Food and Drug Administration; Food and Drug Administration Adverse Event Reporting System; IBD; VAERS; Vaccine Adverse Event Reporting System; acne vulgaris; acne vulgaris/drug therapy; dermatologic agents/adverse effects; inflammatory bowel disease; inflammatory bowel diseases; inflammatory bowel diseases/chemically induced; isotretinoin; postmarketing; product surveillance