Clinical Research and Pharmacovigilance Lecture 7: Benoxaprofen Case Study
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Questions and Answers

What adverse reaction was frequently produced by benoxaprofen?

  • Renal impairment
  • Hepatic failure
  • Photosensitivity reactions (correct)
  • Reduced excretion

    • What was the first drug studied by PEM in England?

  • NSAID
  • HRT
  • Benoxaprofen (correct)
  • COCs

    • What led to the withdrawal of benoxaprofen in 1982?

  • PEM study revealing serious ADRs
  • Reduced excretion in elderly patients
  • Five deaths related to hepatic and renal failure (correct)
  • Primitive computer systems

    • Why were many of the patients who experienced serious ADRs with benoxaprofen elderly?

    <p>Reduced excretion of the drug due to renal impairment</p> Signup and view all the answers

    What pointed to the need for purpose-designed databases in relation to benoxaprofen?

    <p>A large number of spontaneous reports swamping primitive computer systems</p> Signup and view all the answers

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