Skip to main content

Part of the book series: Health Systems Research ((HEALTH))

Abstract

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.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 84.99
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 109.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. Food and Drug Administration. Center for Drugs and Biologies (1984) Minutes of the Arthritis Advisory Committee meeting, Bethesda, Maryland, October 25–26

    Google Scholar 

  2. Food and Drug Administration. Center for Drugs and Biologies (1985) Minutes of the Arthritis Advisory Committee meeting, Bethesda, Maryland, April 29–30

    Google Scholar 

  3. Ferriman A (1985) “Arthritis Drug Alert After 77 Patients Die”, The Observer, December 22

    Google Scholar 

  4. Letter to Secretary Bowen of the Department of Health and Human Services (1986) from Sidney Wolfe, Director, Health Research Group, January 8.

    Google Scholar 

  5. Transcript of Proceedings, United States of America before the Food and Drug Administration, In the Matter of: Piroxicam (1986) Docket Number 86P-0023, Bethesda, Maryland, February 28

    Google Scholar 

  6. Letter to Sidney M. Wolfe, Director, Health Research Group (1986) from Secretary Bowen of the Department of Health and Human Services, July 7

    Google Scholar 

  7. Pfizer Inc. (1986) Submission on the Petition of Public Citizen Health Research Group regarding Feldene (piroxicam), Food and Drug Administration, Docket Number 86P-0023, March 17

    Google Scholar 

  8. Food and Drug Administration, Center for Drugs and Biologies (1986) Recommendation in Piroxicam Imminent Hazard Proceeding, May 14

    Google Scholar 

  9. Memorandum to Secretary of Health and Human Services Otis Bowen (1986) from Frank E. Young, Commissioner, Food and Drug Administration, May 27

    Google Scholar 

  10. Sachs RM, Bortnichak EA (1986) An evaluation of spontaneous adverse drug reaction monitoring systems. Am J Med 81 (suppl 5B): 49–55

    PubMed  CAS  Google Scholar 

  11. Weber JCP (1984) Epidemiology of adverse reactions to nonsteroidal anti-inflammatory drugs. In: Rainsford KD, Velo EP (eds) Advances in Inflammation Research Vol. 6. New York: Raven Press, pages 1–7

    Google Scholar 

  12. FDA (1986) personal communication

    Google Scholar 

  13. Meisel AD (1986) Clinical benefits and comparative safety of piroxicam: analysis of worldwide clinical trials data. Am J Med 81 (suppl 5B): 15–21

    PubMed  CAS  Google Scholar 

  14. Bortnichak EA, Sachs RM (1986) Piroxicam in recent epidemiologic studies. Am J Med 81 (suppl 5B)44–48

    PubMed  CAS  Google Scholar 

  15. Stipp D (1988) “Scientists use medical-record data bases to detect adverse side-effects of drugs”, The Wall Street Journal, March 24, p 33

    Google Scholar 

  16. Beard K, Walker AM, Perera DR, Jick H (1987) Nonsteroidal anti-inflammatory drugs and hospitalization for gastroesophageal bleeding in the elderly. Arch Intern Med 147: 1621–1623

    Article  PubMed  CAS  Google Scholar 

  17. Carson JL, Strom BL, Soper KA et al. (1987) The association of nonsteroidal anti-inflammatory drugs with upper gastrointestinal tract bleeding. Arch Intern Med 147: 85–88

    Article  PubMed  CAS  Google Scholar 

  18. Ray WA (1986) Tennessee Medicaid Database Study at Vanderbilt University. Correspondence (February 25 )

    Google Scholar 

  19. Rawson NSB, Inman WHW (1986) Prescription-event monitoring: recent experience with 5 NSAIDs. Med Tox 1 (suppl 1): 79–82

    Google Scholar 

  20. Levy M, Miller DR, Kaufman DW, et al. (1988) Major upper gastrointestinal tract bleeding: relation to the use of aspirin and other nonnarcotic analgesics. Arch Intern Med 148: 281–285

    Article  PubMed  CAS  Google Scholar 

  21. Sommerville KW, Falkner G, Langman M (1986) Non-steroidal anti-inflammatory drugs and bleeding peptic ulcer. Lancet I: 462–464

    Article  Google Scholar 

  22. Haglund U, Frost L, Wiholm BE: An evaluation of anti-inflammatory and analgesic drug intake among patients with acute gastrointestinal bleeding (abstr)

    Google Scholar 

  23. Giereksky KE, Revhaug A, Warloe T, et al. (1986) Can the incidence of gastrointestinal hemorrhage caused by drugs be reduced? Tidsskr Nor Laegeforen 106: 662–666

    Google Scholar 

  24. O’Brien JD, Burnham WR (1985) Bleeding from peptic ulcers and use of non-steroidal antiinflammatory drugs in the Romford area. Br Med J 291: 1609–1610

    Article  Google Scholar 

  25. The Pink Sheet (1987) In Brief: “The FDA’s imbroglio”, March 2

    Google Scholar 

  26. Data on file, Pfizer, Inc., New York

    Google Scholar 

  27. Sachs RM, Dieck GS (1987) Industry perspectives and the contributions of pharmacoepidemiology to public health. In: Edlavitch S (ed) Pharmacoepidemiology, Proceedings of the Third International Conference on Pharmacoepidemiology, Minneapolis (in press)

    Google Scholar 

Download references

Authors

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 1989 Springer-Verlag Berlin Heidelberg

About this chapter

Cite this chapter

Sachs, R.M., Dieck, G.S. (1989). The Feldene Experience: A Case Study. In: Horisberger, B., Dinkel, R. (eds) The Perception and Management of Drug Safety Risks. Health Systems Research. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-74272-9_11

Download citation

  • DOI: https://doi.org/10.1007/978-3-642-74272-9_11

  • Publisher Name: Springer, Berlin, Heidelberg

  • Print ISBN: 978-3-642-74274-3

  • Online ISBN: 978-3-642-74272-9

  • eBook Packages: Springer Book Archive

Publish with us

Policies and ethics