Replication of the Weber effect using postmarketing adverse event reports voluntarily submitted to the United States Food and Drug Administration.
OBJECTIVE
To validate or refute a widely accepted epidemiologic phenomenon known as the Weber effect by replicating Weber's original observation by using drugs that were marketed in the United States and using reports from a U.S. database.


METHODS
Retrospective analysis of adverse event databases.


METHODS
University research center.
The original nonsteroidal antiinflammatory drugs studied by Weber that were approved by the U.S. Food and Drug Administration (FDA) and marketed in the United States: diclofenac sodium, diclofenac potassium, diflunisal, sulindac, flurbiprofen, and piroxicam.


METHODS
Reports of adverse events submitted to the FDAs Spontaneous Reporting System and the Adverse Event Reporting System from January 1969-December 2000 for these drugs were analyzed according to the number of adverse events reported for each drug per year from the time the drug was approved until December 2000.


RESULTS
Reporting patterns were considered to demonstrate the Weber effect if the highest peak in reports during the first 5 years after product approval occurred during year 2. All five drugs analyzed in this study demonstrated the Weber effect.


CONCLUSIONS
The Weber effect was replicable by using drugs marketed in the United States and using reports that were submitted to a U.S. database. Various other factors affected spontaneous reporting of adverse events, as peaks in the number of reports were seen numerous times for each drug after the initial 5-year marketing period.
Hartnell
Nicole R
NR
College of Pharmacy, Dalhousie University, Halifax, Nova Scotia, Canada. nicole.hartnell@dal.ca
Wilson
James P
JP
D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects* / Q000145:classification; D004008:Diclofenac / Q000009:adverse effects; D004061:Diflunisal / Q000009:adverse effects; D015991:Epidemiologic Measurements; D005480:Flurbiprofen / Q000009:adverse effects; D006801:Humans; D015994:Incidence; D010894:Piroxicam / Q000009:adverse effects; D012189:Retrospective Studies; D013467:Sulindac / Q000009:adverse effects; D013997:Time Factors; D006113:United Kingdom / Q000453:epidemiology; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration
D000894:Anti-Inflammatory Agents, Non-Steroidal; D010894:Piroxicam; D004008:Diclofenac; D013467:Sulindac; D005480:Flurbiprofen; D004061:Diflunisal