title: Value of epidemiologic studies in determining the true incidence of adverse events. The nonsteroidal anti-inflammatory drug story.
abstract: BACKGROUND
  Evidence supporting differential toxic effects of nonsteroidal anti-inflammatory drugs (NSAIDs) often is derived from spontaneous reports of adverse events to the US Food and Drug Administration (FDA). These reports represent observations from an undefined, exposed population that are not collected in a standardized manner and therefore are subject to reporting biases. Epidemiologic studies, in which the numbers of patients experiencing an adverse event and exposed to the drug are known, provide more reliable measures of risk and can place spontaneous reports in perspective.
  
  
  OBJECTIVE
  To compare both data sources with regard to NSAID-associated gastrointestinal, liver, and skin events.
  
  
  METHODS
  We obtained spontaneous reports of these adverse events for diclofenac, nabumetone, naproxen, and piroxicam. Published epidemiologic studies of these events were reviewed.
  
  
  RESULTS
  Spontaneous reports did not mirror reliably the results of epidemiologic studies. Spontaneous reports showed higher associations of gastrointestinal and skin events with nabumetone and piroxicam and hepatic events with diclofenac. Epidemiologic studies generally did not show differential risk among these NSAIDs.
  
  
  CONCLUSIONS
  When the 4 NSAIDs are compared in epidemiologic studies, there is no quantitative basis for identifying 1 as more or less toxic than the others, underlining the hazard of deriving quantitative conclusions from spontaneous reports. Spontaneous reports are an unreliable measure of risk; rather, they may provide evidence of the relative awareness of specific toxic effects among physicians.
authors.affiliation: Degge Group, Ltd, Arlington, Va, USA.
authors.forename: L J
authors.initials: LJ
authors.lastname: Miwa
authors.forename: J K
authors.initials: JK
authors.lastname: Jones
authors.forename: A
authors.initials: A
authors.lastname: Pathiyal
authors.forename: H
authors.initials: H
authors.lastname: Hatoum
mesh_terms: D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D056486:Chemical and Drug Induced Liver Injury / Q000453:epidemiology / Q000209:etiology; D003875:Drug Eruptions / Q000453:epidemiology / Q000209:etiology; D004812:Epidemiologic Methods; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal