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Halcion An Independent Assessment of Safety and Efficacy Data (1997) / Chapter Skim
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Additional Comments on Broader Implications
Pages 94-96

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From page 94...
... The committee believes, therefore, that additional research is needed in this area, in conjunction with the development of improved guidelines for the evaluation of hypnotic agents (see Chapter 2~. The second broad implication arose from information that was collected in an attempt to reconcile the apparent discrepancy between the clinical trial data and the reports of adverse events related to the use of Halcion (triazolam)
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From page 95...
... ; Collection of estimates of drug use in a population; Search for more ADRs attributable to the suspect drug; Examination of in toxicology animal regarding the suspect drug; Examination and reanalyses of the data from clinical trials; - Launching ad hoc case-control or cohort studies exploring the association of the drug and the suspected adverse event; · Querying various drug surveillance systems under contract to FDA and regulatory bodies in other countries; · Querying the drug company that markets the suspect drug; and · Research studies with other designs, including rechallenge and withdrawing the drug (experiment in prevention)
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From page 96...
... The committee recommends that additional effort be dedicated to the postmarketing surveillance and monitoring of hypnotic agents and other drug products, and that this include objective and critical evaluations of integrated data sets of adverse events, actual patient use, and clinical trials. This effort should include special emphasis on (leveloping improved methods for (~)
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Key Terms

  • clinical trials
  • spontaneous reports
  • hypnotic drugs
  • clinically significant
  • spontaneous reporting

  • postmarketing surveillance
  • significant adverse
  • hypnotic agents
  • hypnotic medications
  • suspected adverse

  • improved guidelines
  • pay special
  • unintended threats
  • implication arose
  • integrating evaluation

  • increased attention
  • drug products
  • providers increase
  • medical education
  • trial data

  • indicating patient
  • responding effectively
  • include increased
  • residency programs
  • controlled trials

  • actual patient
  • despite limited
  • specialty examinations
  • include special
  • improved methods


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