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

Chapter: Appendix A: FDA Safety Tables

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Suggested Citation:"Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
×

A
FDA Safety Tables

A-1

 

Non-Geriatric Studies: Anxiety,

 

108

A-2

 

Non-Geriatric Studies: Confusion,

 

109

A-3

 

Non-Geriatric Studies: Depression,

 

110

A-4

 

Non-Geriatric Studies: Irritability,

 

111

A-5

 

Non-Geriatric Studies: Memory Impairment,

 

112

A-6

 

Non-Geriatric Studies: All Psychiatric,

 

113

A-7

 

Non-Geriatric Studies: Sedative/Hypnotic,

 

114

A-8

 

Geriatric Studies: Anxiety,

 

115

A-9

 

Geriatric Studies: Confusion,

 

116

A-10

 

Geriatric Studies: Depression,

 

117

A-11

 

Geriatric Studies: Irritability,

 

118

A-12

 

Geriatric Studies: Memory Impairment,

 

119

A-13

 

Geriatric Studies: All Psychiatric,

 

120

A-14

 

Non-Geriatric Studies,

 

121

A-15

 

Geriatric Studies,

 

122

Source of all tables:. Laughren, T.P. and H. Lee. 1992. Review of adverse event data in Upjohn-sponsored clinical studies of Halcion (triazolam), NDA 17-892. Report made to U.S. Food and Drug Administration.

Suggested Citation:"Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
×

TABLE A-1 Non-Geriatric Studies: Anxiety

TABLE 5.4

NON-GERIATRIC STUDIES: ANXIETY

 

 

DOSE (MG)

 

% WITH ANXIETY

STUDY

WEEKS

TRZ

FLZ

N

TRZ

FLZ

PBO

6401

1

.25

70

2.9

2.9

2401

1

.25-.5

145

4.4

1.3

6400

1

.25-.5

15-30

105

7.5

3.8

6041

1

.5

143

4.3

2.7

6042

1

.5

30

127

4.7

0.0

6004

1

.6

30

37

6.3

23.8

6043

2

.5

277

8.0

5.0

6016

2

.5

30

30

7.1

0.0

6044

2

.5

30

232

6.9

5.2

6402

4

.25

30

81

20.4

22.2

6045

4

.5

62

16.1

12.9

6046

4

.5

30

103

10.9

2.0

6047

6

.5

125

15.0

3.1

6048

6

.5

30

145

4.1

5.6

6023B

12

.5

30

18

8.3

0.0

6023

12

.6

30

51

9.1

0.0

6049

13

.5

30

139

13.5

8.2

Suggested Citation:"Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
×

TABLE A-2 Non-Geriatric Studies: Confusion

TABLE 5.5

NON-GERIATRIC STUDIES: CONFUSION

 

 

DOSE (MG)

 

% WITH CONFUSION

STUDY

WEEKS

TRZ

FLZ

N

TRZ

FLZ

PBO

6401

1

.25

70

0.0

-

0.0

2401

1

.25-.5

145

0.0

0.0

6400

1

.25-.5

15-30

105

0.0

0.0

6041

1

.5

143

0.0

0.0

6042

1

.5

30

127

1.6

0.0

6004

1

.6

30

37

12.5

0.0

6043

2

.5

277

0.0

0.7

6016

2

.5

30

30

0.0

0.0

6044

2

.5

30

232

0.0

0.0

6402

4

.25

30

81

0.0

0.0

6045

4

.5

6'2

6.5

0.0

6046

4

.5

30

10.3

0.0

0.0

6047

6

.5

125

0.0

0.0

6048

6

.5

30

145

0.0

0.0

6023B

12

.5

30

18

0.0

0.0

6023

12

.6

30

51

3.0

5.6

6049

13

.5

30

139

2.7

0.0

Suggested Citation:"Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
×

TABLE A-3 Non-Geriatric Studies: Depression

TABLE 5.6

NON-GERIATRIC STUDIES: DEPRESSION

 

 

DOSE (MG)

 

% WITH DEPRESSION

STUDY

WEEKS

TRZ

FLZ

N

TRZ

FLZ

PBO

6401

1

.25

70

0.0

0.0

2401

1

.25-.5

145

0.0

0.0

66400

1

.25-.5

15-30

105

0.0

0.0

6041

1

.5

143

1.4

2.7

6042

1

.5

3.0

127

0.0

0.0

6004

1

.6

30

37

0.0

0.0

6043

2

.5

277

2.2

0.7

6016

2

.5

30

30

0.0

0.0

6044

2

.5

30

232

2.6

3.4

6402

4

.25

30

81

3.7

0.0

6045

4

.5

62

0.0

0.0

6046

4

.5

30

103

1.8

0.0

6047

6

.5

125

0.0

0.0

6048

6

.5

30

145

4.1

4.2

60238

12

.5

30

18

0.0

0.0

6023

12

6

30

51

3.0

0.0

6049

13

.5

30

139

6.8

6.8

Suggested Citation:"Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
×

TABLE A-4 Non-Geriatric Studies: Irritability

TABLE 5.7

NON-GERIATRIC STUDIES: IRRITABILITY

 

 

DOSE (MG)

 

% WITH IRRITABILITY

STUDY

WEEKS

TRZ

FLZ

N

TRZ

FLZ

PBO

6401

1

.25

70

0.0

0.0

2401

1

.25-.5

145

1.5

3.9

6400

1

.25-.5

15-30

105

0.0

0.0

6041

1

.5

143

0.0

0.0

6042

1

.5

30

127

3.1

1.6

6004

1

.6

30

37

0.0

0.0

6043

2

.5

277

0.0

2.2

6016

2

.5

30

30

0.0

0.0

6044

2

.5

30

232

0.0

1.7

6402

4

.25

30

81

0.0

3.7

6045

4

.5

62

0.0

0.0

6046

4

.5

30

103

1.8

0.0

6047

6

.5

125

0.0

0.0

6048

6

.5

30

145

0.0

0.0

6023B

12

.5

30

18

0.0

0.0

6023

12

.6

30

51

0.0

0.0

6049

13

.5

30

139

1.4

0.0

Suggested Citation:"Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
×

TABLE A-5 Non-Geriatric Studies: Memory Impairment

TABLE 5.8

NON-GERIATRIC STUDIES: MEMORY IMPAIRMENT

 

 

DOSE (MG)

 

% WITH MEMORY IMPAIRMENT

STUDY

WEEKS

TRZ

FLZ

N

TRZ

FLZ

PBO

6401

1

.25

70

0.0

0.0

2401

1

.25-.5

145

0.0

0.0

6400

1

.25-.5

15-30

105

0.0

0.0

6041

1

.5

143

0.0

0.0

6042

1

.5

30

127

1.6

1.6

6004

1

.6

30

37

6.3

0.0

6043

2

.5

277

0.0

0.0

6016

2

.5

30

30

0.0

0.0

6044

2

.5

30

232

0.0

0.0

6402

4

.25

30

81

0.0

0.0

6045

4

.5

62

0.0

0.0

6046

4

.5

30

103

0.0

0.0

6047

6

.5

125

1.7

0.0

6048

6

.5

30

145

1.4

0.0

6023B

12

.5

30

18

8.3

0.0

6023

12

.6

30

51

15.2

0.0

6049

13

.5

30

139

6.8

0.0

Suggested Citation:"Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
×

TABLE A-6 Non-Geriatric Studies: All Psychiatric

TABLE 5.9

NON-GERIATRIC STUDIES: 'ALL PSYCHIATRIC'

 

 

DOSE (MG)

 

% WITH 'ALL PSYCHIATRIC'

STUDY

WEEKS

TRZ

FLZ

N

TRZ

FLZ

PBO

6401

1

.25

70

5.7

2.9

2041

1

.25-.5

145

5.9

3.9

6400

1

.25-.5

15-30

105

11.3

3.8

6041

1

.5

143

5.7

5.5

6042

1

.5

30

127

7.8

3.2

6004

1

.6

30

37

25.0

42.9

6043

2

.5

277

10.9

10.1

6016

2

.5

30

30

7.1

0.0

6044

2

.5

30

232

9.5

9.5

6402

4

.25

30

81

25.9

29.6

6045

4

.5

62

29.0

12.9

6046

4

.5

30

103

12.7

0.0

6047

6

.5

125

15.0

7.7

6048

6

.5

30

145

9.5

0.0

6023B

1.2

.5

30

18

8.3

16.7

6023

12

.6

30

51

21.2

22.2

6049

13

.5

30

139

23.0

15.1

Suggested Citation:"Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
×

TABLE A-7 Non-Geriatric Studies: Sedative/Hypnotic

TABLE 5.10

NON-GERIATRIC STUDIES: 'SEDATIVE/HYPNOTIC'

 

 

DOSE (MG)

 

% WITH 'SEDATIVE HYPNOTIC'

STUDY

WEEKS

TRZ

FLZ

N

TRZ

FLZ

PBO

6401

1

.25

70

17.1

11.4

2401

1

.25-.5

145

75.0

84.4

6400

1

.25-.5

15-30

105

20.8

21.2

6041

1

.5

143

24.3

12.3

6042

1

..5

30

127

21.9

17.5

6004

1

.6

30

37

50.0

47.6

6043

2

.5

277

35.5

19.4

6016

2

.5

30

30

14.3

25.0

6044

2

.5

30

232

37.1

44.0

6402

4

.25

30

81

33.3

59.3

6045

4

.5

62

54.8

12.9

6046

4

.5

30

103

43.6

36.0

6047

6

.5

125

36.7

13.8

6048

6

.5

30

145

25.7

31.0

6023B

12

.5

30

18

41.7

50.0

6023

12

.6

30

51

33.3

77.8

6049

13

.5

30

139

37.8

42.5

Suggested Citation:"Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
×

TABLE A-8 Geriatric Studies: Anxiety

TABLE 5.11

GERIATRIC STUDIES: ANXIETY

 

 

DOSE (MG)

 

% WITH ANXIETY

STUDY

WEEKS

TRZ

FLZ

N

TRZ

FLZ

PBO

6417

1

.125

90

2.2

9.1

6417A

1

.125-.25

37

0.0

15.8

6061

1

.25

59

0.0

0.0

6062

1

.25

15

71

0.0

0.0

6063

2

.25

38

5.6

10.0

6064

2

.25

15

43

10.0

0.0

6065

4

.25

15

41

14.3

0.0

0.0

2601

4

.25-.5

15-30

121

30.0

17.5

14.6

Suggested Citation:"Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
×

TABLE A-9 Geriatric Studies: Confusion

TABLE 5.12

GERIATRIC STUDIES: CONFUSION

 

 

DOSE (MG)

 

% WITH CONFUSION

STUDY

WEEKS

TRZ

FLZ

N

TRZ

FLZ

PBO

6417

1

.125

90

0.0

2.3

6417A

1

.125-.25

37

0.0

0.0

6061

1

.25

59

0.0

0.0

6062

1

.25

15

71

0.0

0.0

6063

2

.25

38

5.6

0.0

6064

2

.25

15

43

0.0

4.3

6065

4

.25

15

41

0.0

0.0

0.0

2601

4

.25-.5

15-30

121

5.0

2.5

2.4

Suggested Citation:"Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
×

TABLE A-10 Geriatric Studies: Depression

TABLE 5.13

GERIATRIC STUDIES: DEPRESSION

 

 

DOSE (MG)

 

% WITH DEPRESSION

STUDY

WEEKS

TRZ

FLZ

N

TRZ

FLZ

PBO

6417

1

.125

90

0.0

0.0

6417A

1

.125-.25

37

0.0

0.0

6061

1

.25

59

0.0

0.0

6062

1

.25

15

71

0.0

0.0

6063

2

.25

38

5.6

0.0

6064

2

.25

15

43

10.0

0.0

6065

4

.25

15

41

0.0

0.0

0.0

2601

4

.25-.5

15-30

121

7.5

5.0

7.3

Suggested Citation:"Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
×

TABLE A-11 Geriatric Studies: Irritability

TABLE 5.14

GERIATRIC STUDIES: IRRITABILITY

 

 

DOSE (MG)

 

% WITH IRRITABILITY

STUDY

WEEKS

TRZ

FLZ

N

TRZ

FLZ

PBO

6417

1

.125

90

0.0

0.0

6417A

1

.125-.25

37

0.0

0.0

6061

1

.25

59

0.0

0.0

6062

1

.25

15

71

0.0

0.0

6063

2

.25

38

0.0

0.0

6064

2

.25

15

43

0.0

0.0

6065

4

.25

1.5

41

7.1

0.0

0.0

2601

4

.25-.5

15-30

121

5.0

0.0

2.4

Suggested Citation:"Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
×

TABLE A-12 Geriatric Studies: Memory Impairment

TABLE 5.15

GERIATRIC STUDIES: MEMORY IMPAIRMENT

 

 

DOSE (MG)

 

% WITH MEMORY IMPAIRMENT

STUDY

WEEKS

TRZ

FLZ

N

TRZ

FLZ

PBO

6417

1

.125

90

0.0

0.0

6417A

1

.125-.25

37

0.0

0.0

6061

1

.25

59

0.0

0.0

6062

1

.25

15

71

0.0

0.0

6063

2

.25

38

0.0

0.0

6064

2

.25

15

43

0.0

0.0

6065

4

.25

15

41

0.0

0.0

0.0

2601

4

.25-.5

15-30

121

2.5

0.0

0.0

Suggested Citation:"Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
×

TABLE A-13 Geriatric Studies: All Psychiatric

TABLE 5.16

GERIATRIC STUDIES: 'ALL PSYCHIATRIC'

 

 

DOSE (MG)

 

% WITH 'ALL PSYCHIATRIC'

STUDY

WEEKS

TRZ

FLZ

N

TRZ

FLZ

PBO

6417

1

.125

90

2.2

13.6

6417A

1

.1250.25

37

0.0

15.8

6061

1

.25

59

0.0

0.0

6062

1

.25

15

71

0.0

0.0

6063

2

.25

38

11.1

10.1

6064

2

25

15

43

15.0

4.3

6065

4

.25

15

41

14.3

0.0

0.0

2601

4

.25-.5

15-30

121

47.5

32.5

26.8

Suggested Citation:"Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
×

TABLE A-14 Non-Geriatric Studies

TABLE 2.2:

NON-GERIATRIC STUDIES

 

 

DOSE (MG)

GROUPS/SAMPLE SIZE

STUDY

WEEKS

TRZ

FLZ

TRZ

FLZ

PBO

6401

1

.25

35

35

2401

1

.25-.5

66

77

6400

1

.25-.5

15-30

53

52

6041

1

.5

70

72

6042

1

.5

30

62

59

6004

1

.6

30

16

21

6043

2

.5

138

135

6016

2

.5

30

14

16

6044

2

.5

30

112

110

6402

4

.25

30

54

27

6045

4

.5

31

31

6046

4

.5

30

55

50

6047

6

.5

59

64

6048

6

.5

30

72

71

6023B

12

.5

30

9

6

6023

12

.6

30

33

18

6049

13

.5

30

74

73

Suggested Citation:"Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
×

TABLE A-15 Geriatric Studies

TABLE 2.3:

GERIATRIC STUDIES

 

 

DOSE (MG)

GROUPS/SAMPLE SIZE

STUDY

WEEKS

TRZ

FLZ

TRZ

FLZ

PBO

6417

1

.125

46

44

6417A

1

.125-.25

18

19

6061

1

.25

31

28

6062

1

.25

15

36

35

6063

2

.25

18

20

6064

2

.25

15

20

23

6065

4

.25

15

14

13

14

2601

4

.25-.5

15-30

32

33

27

Suggested Citation:"Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
×
Page 107
Suggested Citation:"Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
×
Page 108
Suggested Citation:"Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
×
Page 109
Suggested Citation:"Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
×
Page 110
Suggested Citation:"Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
×
Page 111
Suggested Citation:"Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
×
Page 112
Suggested Citation:"Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
×
Page 113
Suggested Citation:"Appendix A: FDA Safety Tables." 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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Next: Appendix B: Summary Tables of Literature Reviewed for Safety of Halcion »
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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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