National Academies Press: OpenBook

Halcion: An Independent Assessment of Safety and Efficacy Data (1997)

Chapter: Appendix E: Resources Reviewed by the Committee

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Suggested Citation:"Appendix E: Resources Reviewed by the Committee." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
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E
Resources Reviewed by the Committee

Title

Contents

Source

General background

FDA Task Force Report

 

FDA

Public Citizen Petition

The Public Citizen Petition to Remove Halcion from the Market

Public Citizen

Upjohn Response to Petition

Upjohn's Response to the Public Citizen Petition

FDA

IOM Study on Sleep

Basic Sleep Research, 1990

IOM

IOM Study on Sleeping Pills

Sleeping Pills, Insomnia, and Medical Practice, 1979

IOM

Miscellaneous information provided by Upjohn

Sales data, patent data, and information on generic compounds

Upjohn

Miscellaneous information provided by FDA

Summary basis of approval, labeling information, information on generic compounds, and guidelines for the clinical evaluation of hypnotic drugs

FDA

Published literature

IOM search

Articles concerning Halcion

IOM

Literature on Halcion

 

FDA

Suggested Citation:"Appendix E: Resources Reviewed by the Committee." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
×

Title

Contents

Source

Upjohn literature search

Literature search identifying later studies

Upjohn

Literature provided by Public Citizen

All cited references, including Kales (1996), A Reassessment of Triazolam and Conflicting Scientific Expertise in British and American Medicines Control

Public Citizen

International data

Canadian product monograph for Halcion

 

Canada

Evaluations of Medications for Insomnia in Canada (EMIC)

 

Upjohn

Medicines Control Agency letter

Letter from the Licensing Authority to Upjohn, 1992

Public Citizen

Report of the Committee on Proprietary Medicinal Products

 

Upjohn

Report of the Committee on the Safety of Medicines

 

Public Citizen

UK Panel Report

Report of the Panel of Persons Appointed

United Kingdom

VAMP Information

Information on the General Practice Research Database (previously known as the Value Added Medical Practice [VAMP] Database)

Upjohn

Premarketing clinical trial data (from the New Drug Application)

Preapproval reviews

 

FDA

Premarketing clinical trials

 

FDA

Report of the database remake

 

FDA

Suggested Citation:"Appendix E: Resources Reviewed by the Committee." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
×

Title

Contents

Source

Upjohn summaries of non-pivotal clinical trials

 

FDA

Efficacy protocols

Protocols for 20 studies with lower dosages reviewed for efficacy

Upjohn

Information from FDA Psychopharmacologic Drugs Advisory Committee meetings

Transcript of the PDAC meetings: 1977, 1989, 1992

 

FDA

FDA mailing to 1989 and 1992 PDACS

FDA mailing to 1989 PDAC

Upjohn

Brochures with summary information prepared by Upjohn for the PDAC meetings, 1989 and 1992

Upjohn brochure prepared for the PDAC 1989

Upjohn

Integrated Summaries of Safety and Efficacy

Integrated safety study

Integrated studies' of safety

Upjohn

Integrated efficacy study

Integrated studies of effectiveness

Upjohn

Integrated dropout listings

Integrated summary of safety dropout listings

Upjohn

Statistical reviews

 

FDA

Epidemiological reviews

 

FDA

Pharmocokinetic and pharmacodynamic data

 

Upjohn

Postmarketing surveillance data

Annual Adverse Event Reports

 

FDA

Postmarketing protocols: 1994-1996

Protocols, M/2100/0235, M/2100/0366, and M/2100/0373

FDA

Upjohn Annual Reports to FDA, 1990-1997

 

FDA

Suggested Citation:"Appendix E: Resources Reviewed by the Committee." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
×

Title

Contents

Source

Spontaneous report data

FDA memoranda

FDA memoranda provided by Diane Wysowski

FDA

SRS data

Data on the FDA Spontaneous Reporting System

FDA

Use, sales, and prescription data

IMS statistics

IMS statistics regarding reasons for prescriptions, high dose usage, and chronic usage

Upjohn

Use statistics

Use statistics from IMS and health maintenance organization data regarding reasons for prescriptions, high dose usage, and chronic usage

FDA

Sales information

Number of packages sold in the United States, 1982-1997

Upjohn

Suggested Citation:"Appendix E: Resources Reviewed by the Committee." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
×
Page 146
Suggested Citation:"Appendix E: Resources Reviewed by the Committee." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
×
Page 147
Suggested Citation:"Appendix E: Resources Reviewed by the Committee." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
×
Page 148
Suggested Citation:"Appendix E: Resources Reviewed by the Committee." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
×
Page 149
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Regulatory agencies within the United States and the United Kingdom, among several other countries, have reviewed extensively the safety and efficacy of Halcion (triazolam)--a once commonly used hypnotic drug. Concerns began to emerge about the safety of Halcion when a Dutch physician reported a possible link between it and a syndrome that included such effects as depression, amnesia, hallucinations, and increased anxiety. In addition, in 1991 its manufacturer, Upjohn, noted that "errors had been identified in a report of one of the clinical studies included in the original" application for approval. Since then, the drug has been removed from the market in several countries, whereas in the United States and Canada, the drug's labeling has been modified to reduce the recommended dose and duration of treatment and to heighten awareness of possible side effects. Yet different data and analyses have resulted in conflicting messages that are difficult to reconcile and interpret. In response to a request from the Food and Drug Administration to resolve these controversial issues related to the safety and efficacy of Halcion, this IOM book assesses the adequacy of the drug's clinical trials; the quality and quantity of data on adverse reactions; overall confidence in the data on effectiveness, adverse events, and side effects at different doses; and whether additional studies are needed.

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