The Feldene Experience: A Case Study

  • R. M. Sachs
  • G. S. Dieck
Part of the Health Systems Research book series (HEALTH)


The following illustrates an actual experience involving allegations of safety problems with the nonsteroidal anti-inflammatory drug (NSAID) Feldene (piroxicam). It is intended to serve as a case study of the ramifications of examining complex issues of risk analysis in a public forum under volatile conditions. Although the safety of the drug was ultimately established, both the process and its conclusion had significant impact on the manufacturer, the regulatory agency, physicians and patients. This discussion will focus particularly on the roles played in this episode by pharmacoepidemiology and the media.


Bleeding Peptic Ulcer Gastrointestinal Tract Bleeding Boston Collaborative Drug Surveillance Program Spontaneous Adverse Drug Reaction Prescription Event Monitoring Study 
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Copyright information

© Springer-Verlag Berlin Heidelberg 1989

Authors and Affiliations

  • R. M. Sachs
  • G. S. Dieck

There are no affiliations available

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