Clinical Effects of Pentazocine in Hospitalized Medical Patients A Report from Boston University
the
Boston Medical
Collaborative Center
Drug
Surveillance
RUSSELL
S
its
INCE
States
in
introduction in 1967, pentazocine*
a parenterally been widely erate
to
administered used for the severe
pain.
measure
of
and
pentazocine though
the
of The gram
untoward Boston is
been efficacy
its
past pharre-
liability
of
conducted. to A
other variety
gastroin-
Drug
Surveillance
Public
health
ProService
Contract No. N01-GM-4-2148 from the National Institute of General Medical Sciences (NIGMS) and in part by grants from the United States Food and Drug Administration; the Canadian Food and Drug Directorate; time Israeli Ministry of Health; the Hadassah Medical Organization; the Kupat-Holim; Auckland Hospital, Auckland, New Zealand; the Roger Williams General Hospital (Brown University NIGMS Grant No. GM 165-38-02); the Scottish Home and Health Department; and Hoffmann-LaRoche mc, Nutley, N.J. *Trade
names
New tories,
York, N.Y.; Manurewa,
198
Taiwin,
Winthrop
Fortral, Auckland,
Laboratories, Winthrop New
on
of
pentazocine
616
may
This
data
the
who
reported,
predispose
clinical
patients and
on
observations
medical drug
received
presents
efficacy
based
the
and
been
communication
hospitalized
ceived
have
toxicity
patients
orally
and
of who
816
re-
patients
it parenterally.
Al-
of pentazocine
neuropsychiatric,
by
oral a large
Mass.
information on the freadverse reactions or on
that
them.
Waltham,
cardiovascular,
effects
factors
to
Ph.D.
respiratory,
but there is little quency of these the
the
value relative is uncertain.
Collaborative supported
has mod-
on the adverse
dependence
analgesic
is established, strong analgesics
Over studies efficacy,
have
for
Pharm.D..
neuromuscular
hydrochloride
1969 achieved
acceptance.
twelve years, many macologic actions, actions,
in has
MILLER.
testinal,
United lactate,
analgesic, relief of
The
salt was introduced therapy, and it also
the
R.
Program,
LaboraZealand.
Patients
and
The
methods
the
Boston
lance
Methods and
Program
viously.1 studies, utilizes
have
In the of
control receives
groups; a drug
monitors tioned
is no
into
treatment
physician.
routine
of
self-coding
forms
consecutively The
hospital
random and
a patient solely by
surveillance
interfere
with care.
the
Trained
or pharmacists) wards use standardized to
record
admitted Journal
not
The
not
(nurses medical
pre-
experimental Program
whether or is determined
does
on
described
There
patients
patient’s
program
of
Surveil-
or nonexperimcntal
research. of
on
been
contrast to Drug Surveillance
allocation
normal
findings Drug
epidemiologic
methods
the
general
Collaborative
of
information patients.
Clinical
sta-
Data
Pharmacology
PENTAZOCINE
are
collected
oim patients’
diagnoses, administered,
the
and duration is initially
of therapy. prescribed for
adverse
well.
This
lected medical
When a a patient,
reactions
report
is
since 1966 patients
are based
drug the
indicaphysician.
of therapy, descriptions on
on 17,068 in twelve
as
data
col-
hospitalized hospitals
given are treated received
satisfactory
in
recipients. no
In
judgment
(per
cent
in
the United States, Canada, Israel, New Zealand, and Scotland, of whom 616 (3.6
(Table primary
per
and
the
failure
drug
25
per
cent)
received
(4.8
pentazocine
per
parenterally
cent)
orally
received
during
one
the
or
more
Results The
nmean
age
of
time 616
received oral pentazocine and 53 per cent were male. of parenteral and 57 per tions
for
cent
oral
recipients were
pentazocine
were
cent; 2 per
pentazoeine headache, cent; and
cent; were
4 per cent, other, 3 per
pain,
91
and other, figures for pain,
91 per
preoperative, cent. The unit
Unit
Doses
cent
patients
Hydrochloride, Dose
oral
(mg)
(%)
receiving Lactate, parenteral
15-25
2
6
30
5
80
40-45
-
3
50
90
4
60
-
5
100
1
Other
2
February-March,
1975
-
2
made.
rates cent
rates
Table
cases was of
patients neoplastic 36
oral
with a disease,
per
cent
amid Among
patients the
16
and
parenteral
diagnoses, were
inpain
per
respeccent
and
comparative
efficacy
for pemmtazocine and Parenteral pemmtazoeine
II
other analand codeine
had similar were nearly phine and gesics,
simows
failure rates, both of which twice as high as those of mormeperidine. Among oral anal-
however,
there
were
differences
in
pentazocine
in mg/kg
not
with efficacy. reactions were
correlate Adverse
efficacy.
recipients
of body
(2.9 aimd
no Time
per
37
striking dose
recipients
paremiteral
drug.
The
Table III. including
tiomms, disoricmmtation,
bizarre
vertigo,
were
effects
for
time most both
pentazocinc. of pentazocine (2.0 had of the
Ten
oral
(4.5
per
no pato both reactions Neuropsyhallucina-
feelings, untoward
and
parenteral
oral
in
of
common
recipients hydrochloride
did
reported
of parenteral pentazocine; had an adverse reaction and
of
weight
cent)
are described in ehiatric reactions,
became
rate
cent.
ratings gesics.
cipients lactate Three
cent,
failure among
respectively.
failure
un-
17 per
made) cause
were for
or
The
was probable
tive
oral Per
remaining
primary
cent) tients
of Pentazocine
the was
hospital
of pentazocine
unsatisfactory
pcntazocimme I
cent
other
18 TABLE
83 per
with
who
52 years, mean age
was 51 years, male. Time indica-
per cent; headache, 8 per 1 per cent. Corresponding parenteral
patients was The
by
satisfactory
II). Among diagnosis of
10 per
pentazocine
either
judgment by the
pentazocine,
admis-
sions.
of parenteral or subcutaneous). was judged
as
where fluenced
816
shown in Table I. Pawith oral pentazocine a 50-nmg dose; 30 mg was
the usual dose (iimtramuscular Drug efficacy plmysicians
judgof sus-
recorded
PATIENTS
doses tients usually
of all drugs of dosage
the therapeutic prescribing
Reasons for termination ments of efficacy, and
HOSPITALIZED
characteristics,
clinical effects and full details
monitor obtains tion from the
pected
IN
(1.6
and
per cent) and 16 re-
per cent) of pentazocine neuropsychiatric reactions. patients with hallucinations
frankly
psychotic
and
had 199
MILLER
TABLE Failure
Rates
for
Pentazocine
and
II
Other
Patients diagnosis
No.
Drug* Oral Analgesics Pentazocine Acetaminophen
*
and
trade
names
of
16 16 13 13 16 15 12
141
15
112 60 303 128
25 25 15 15
488 121 890 438
10
drugs:
acetaminophen-Tylenol,
Reactions
No. of patients
vomiting
Total 200
with
adverse
reactions
Tempra,
Pentazocine hydrochloride
cent
Pentazocine
of
recipients
lactate
Per of
No.
patients
(%)
cent (%)
-
9
1.1
0.6
1
0.1
4 1 1 3 1
0.6 0.2 0.2 0.5 0.2
7 2 2 2 2
-
1
0.9 0.2 0.2 0.2 0.2 0.1
2 1
0.3 0.2
-
-
1
0.1 0.5
-
-
4
-
-
1
0.1
-
-
1
0.1
-
-
1
0.1
-
-
1
0.1
-
-
1
0.1
18
2.9
The
37
Journal
of
recipients
4
-
Other Dry mouth Hives or itching Injection complications Respiratory depression Anorexia and hot flashes Miosis Dyspnea Flaccid bladder
Nebs,
propoxyphene-Darvon.
III to
-
Neuropsychiatric Hallucinations Disorientation Bizarre feelings Vertigo Nightmares Drowsiness
12 6 6
Valadol,
Fortral;
Per
Gastrointestinal Nausea or Constipation
of
343 374 324 342 314 137 255
Pentazocine
reactions
Per cent unsatisfactory
36 26 34 26 36 27 27 34
TABLE
Adverse
with other diagnoses
110 72 64 187 59 102 184 280
pentazoeine-Talwin,
Adverse
No.
Pain
(%)
Analgesics lactate
meperidine-Demeroi; names for mixtures.
Patients primary
Per cent unsatisfactory
of
for
patients
HC1
Nonproprietary
prinmary cancer
Given
(%)
Codeine Meperidine Morphine
Dularin; ** Trade
with of
when
patients
Aspirin Codeine Darvon Compound* Meperidine Percodan* Propoxyphene Parenteral Pentazocine
Analgesics
of
4.5
Clinical
Pharmacology
PENTAZOCINE
paranoid described
delusions. their
being ing,
like
Three adverse
of
adverse
effect
for
nausea Injection or
adverse
reactions
Two
pemmdemmt on
mg
was
man whom
more
to
was
be
in
to
lactate.
pain
mg
she
was
while
uncomfortable.
When
after
eight
mg)
of
given
50 mg
60-year-old
failure
and
with
frequent
IV);
because
Pentazocine 15 to 40 to
30 60
Number patients
dosage
lactate* mg mg
Total Pentazocine 25 to 60 to
hydrochloride* 50 mg 100 mg
Total *
February-March,
x2(d.f.=1)
=15.4,
x2(d.f.=1)
=5.9,
1975
P
the
Boston Medical
Collaborative Center
Drug
Surveillance
RUSSELL
S
its
INCE
States
in
introduction in 1967, pentazocine*
a parenterally been widely erate
to
administered used for the severe
pain.
measure
of
and
pentazocine though
the
of The gram
untoward Boston is
been efficacy
its
past pharre-
liability
of
conducted. to A
other variety
gastroin-
Drug
Surveillance
Public
health
ProService
Contract No. N01-GM-4-2148 from the National Institute of General Medical Sciences (NIGMS) and in part by grants from the United States Food and Drug Administration; the Canadian Food and Drug Directorate; time Israeli Ministry of Health; the Hadassah Medical Organization; the Kupat-Holim; Auckland Hospital, Auckland, New Zealand; the Roger Williams General Hospital (Brown University NIGMS Grant No. GM 165-38-02); the Scottish Home and Health Department; and Hoffmann-LaRoche mc, Nutley, N.J. *Trade
names
New tories,
York, N.Y.; Manurewa,
198
Taiwin,
Winthrop
Fortral, Auckland,
Laboratories, Winthrop New
on
of
pentazocine
616
may
This
data
the
who
reported,
predispose
clinical
patients and
on
observations
medical drug
received
presents
efficacy
based
the
and
been
communication
hospitalized
ceived
have
toxicity
patients
orally
and
of who
816
re-
patients
it parenterally.
Al-
of pentazocine
neuropsychiatric,
by
oral a large
Mass.
information on the freadverse reactions or on
that
them.
Waltham,
cardiovascular,
effects
factors
to
Ph.D.
respiratory,
but there is little quency of these the
the
value relative is uncertain.
Collaborative supported
has mod-
on the adverse
dependence
analgesic
is established, strong analgesics
Over studies efficacy,
have
for
Pharm.D..
neuromuscular
hydrochloride
1969 achieved
acceptance.
twelve years, many macologic actions, actions,
in has
MILLER.
testinal,
United lactate,
analgesic, relief of
The
salt was introduced therapy, and it also
the
R.
Program,
LaboraZealand.
Patients
and
The
methods
the
Boston
lance
Methods and
Program
viously.1 studies, utilizes
have
In the of
control receives
groups; a drug
monitors tioned
is no
into
treatment
physician.
routine
of
self-coding
forms
consecutively The
hospital
random and
a patient solely by
surveillance
interfere
with care.
the
Trained
or pharmacists) wards use standardized to
record
admitted Journal
not
The
not
(nurses medical
pre-
experimental Program
whether or is determined
does
on
described
There
patients
patient’s
program
of
Surveil-
or nonexperimcntal
research. of
on
been
contrast to Drug Surveillance
allocation
normal
findings Drug
epidemiologic
methods
the
general
Collaborative
of
information patients.
Clinical
sta-
Data
Pharmacology
PENTAZOCINE
are
collected
oim patients’
diagnoses, administered,
the
and duration is initially
of therapy. prescribed for
adverse
well.
This
lected medical
When a a patient,
reactions
report
is
since 1966 patients
are based
drug the
indicaphysician.
of therapy, descriptions on
on 17,068 in twelve
as
data
col-
hospitalized hospitals
given are treated received
satisfactory
in
recipients. no
In
judgment
(per
cent
in
the United States, Canada, Israel, New Zealand, and Scotland, of whom 616 (3.6
(Table primary
per
and
the
failure
drug
25
per
cent)
received
(4.8
pentazocine
per
parenterally
cent)
orally
received
during
one
the
or
more
Results The
nmean
age
of
time 616
received oral pentazocine and 53 per cent were male. of parenteral and 57 per tions
for
cent
oral
recipients were
pentazocine
were
cent; 2 per
pentazoeine headache, cent; and
cent; were
4 per cent, other, 3 per
pain,
91
and other, figures for pain,
91 per
preoperative, cent. The unit
Unit
Doses
cent
patients
Hydrochloride, Dose
oral
(mg)
(%)
receiving Lactate, parenteral
15-25
2
6
30
5
80
40-45
-
3
50
90
4
60
-
5
100
1
Other
2
February-March,
1975
-
2
made.
rates cent
rates
Table
cases was of
patients neoplastic 36
oral
with a disease,
per
cent
amid Among
patients the
16
and
parenteral
diagnoses, were
inpain
per
respeccent
and
comparative
efficacy
for pemmtazocine and Parenteral pemmtazoeine
II
other analand codeine
had similar were nearly phine and gesics,
simows
failure rates, both of which twice as high as those of mormeperidine. Among oral anal-
however,
there
were
differences
in
pentazocine
in mg/kg
not
with efficacy. reactions were
correlate Adverse
efficacy.
recipients
of body
(2.9 aimd
no Time
per
37
striking dose
recipients
paremiteral
drug.
The
Table III. including
tiomms, disoricmmtation,
bizarre
vertigo,
were
effects
for
time most both
pentazocinc. of pentazocine (2.0 had of the
Ten
oral
(4.5
per
no pato both reactions Neuropsyhallucina-
feelings, untoward
and
parenteral
oral
in
of
common
recipients hydrochloride
did
reported
of parenteral pentazocine; had an adverse reaction and
of
weight
cent)
are described in ehiatric reactions,
became
rate
cent.
ratings gesics.
cipients lactate Three
cent,
failure among
respectively.
failure
un-
17 per
made) cause
were for
or
The
was probable
tive
oral Per
remaining
primary
cent) tients
of Pentazocine
the was
hospital
of pentazocine
unsatisfactory
pcntazocimme I
cent
other
18 TABLE
83 per
with
who
52 years, mean age
was 51 years, male. Time indica-
per cent; headache, 8 per 1 per cent. Corresponding parenteral
patients was The
by
satisfactory
II). Among diagnosis of
10 per
pentazocine
either
judgment by the
pentazocine,
admis-
sions.
of parenteral or subcutaneous). was judged
as
where fluenced
816
shown in Table I. Pawith oral pentazocine a 50-nmg dose; 30 mg was
the usual dose (iimtramuscular Drug efficacy plmysicians
judgof sus-
recorded
PATIENTS
doses tients usually
of all drugs of dosage
the therapeutic prescribing
Reasons for termination ments of efficacy, and
HOSPITALIZED
characteristics,
clinical effects and full details
monitor obtains tion from the
pected
IN
(1.6
and
per cent) and 16 re-
per cent) of pentazocine neuropsychiatric reactions. patients with hallucinations
frankly
psychotic
and
had 199
MILLER
TABLE Failure
Rates
for
Pentazocine
and
II
Other
Patients diagnosis
No.
Drug* Oral Analgesics Pentazocine Acetaminophen
*
and
trade
names
of
16 16 13 13 16 15 12
141
15
112 60 303 128
25 25 15 15
488 121 890 438
10
drugs:
acetaminophen-Tylenol,
Reactions
No. of patients
vomiting
Total 200
with
adverse
reactions
Tempra,
Pentazocine hydrochloride
cent
Pentazocine
of
recipients
lactate
Per of
No.
patients
(%)
cent (%)
-
9
1.1
0.6
1
0.1
4 1 1 3 1
0.6 0.2 0.2 0.5 0.2
7 2 2 2 2
-
1
0.9 0.2 0.2 0.2 0.2 0.1
2 1
0.3 0.2
-
-
1
0.1 0.5
-
-
4
-
-
1
0.1
-
-
1
0.1
-
-
1
0.1
-
-
1
0.1
-
-
1
0.1
18
2.9
The
37
Journal
of
recipients
4
-
Other Dry mouth Hives or itching Injection complications Respiratory depression Anorexia and hot flashes Miosis Dyspnea Flaccid bladder
Nebs,
propoxyphene-Darvon.
III to
-
Neuropsychiatric Hallucinations Disorientation Bizarre feelings Vertigo Nightmares Drowsiness
12 6 6
Valadol,
Fortral;
Per
Gastrointestinal Nausea or Constipation
of
343 374 324 342 314 137 255
Pentazocine
reactions
Per cent unsatisfactory
36 26 34 26 36 27 27 34
TABLE
Adverse
with other diagnoses
110 72 64 187 59 102 184 280
pentazoeine-Talwin,
Adverse
No.
Pain
(%)
Analgesics lactate
meperidine-Demeroi; names for mixtures.
Patients primary
Per cent unsatisfactory
of
for
patients
HC1
Nonproprietary
prinmary cancer
Given
(%)
Codeine Meperidine Morphine
Dularin; ** Trade
with of
when
patients
Aspirin Codeine Darvon Compound* Meperidine Percodan* Propoxyphene Parenteral Pentazocine
Analgesics
of
4.5
Clinical
Pharmacology
PENTAZOCINE
paranoid described
delusions. their
being ing,
like
Three adverse
of
adverse
effect
for
nausea Injection or
adverse
reactions
Two
pemmdemmt on
mg
was
man whom
more
to
was
be
in
to
lactate.
pain
mg
she
was
while
uncomfortable.
When
after
eight
mg)
of
given
50 mg
60-year-old
failure
and
with
frequent
IV);
because
Pentazocine 15 to 40 to
30 60
Number patients
dosage
lactate* mg mg
Total Pentazocine 25 to 60 to
hydrochloride* 50 mg 100 mg
Total *
February-March,
x2(d.f.=1)
=15.4,
x2(d.f.=1)
=5.9,
1975
P
