A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Pondimin Warnings, Precautions, Pregnancy, Nursing, Abuse - Fenfluramine
Pondimin Warnings, Precautions, Pregnancy, Nursing, Abuse - Fenfluramine
WARNINGS
When tolerance to
the "anorectic" effect
develops, the maximum recommended dose
should not be exceeded in an attempt to increase the effect; rather,
the drug should be discontinued.
PRECAUTIONS
General
Fenfluramine differs in its pharmacological profile
from other "anorectic" drugs with which the prescribing
practitioner may
be familiar. Correspondingly, there are possible adverse effects
not associated with other "anorectics"; such effects include
those of diarrhea,
sedation, and depression.
The possibility of these effects should be weighed against the possible
advantage of decreased central nervous
system stimulation
and/or abuse potential.
There have been four cases of pulmonary
hypertension reported
in association with fenfluramine use. Two cases were apparently
reversible after
discontinuation of fenfluramine, but evidence
of pulmonary hypertension
recurred in one of these patients upon rechallenge with fenfluramine.
A third patient was
initially improved with nifedipine treatment,
but was noted to have increased pulmonary arterial
pressure again at a
four month follow up visit. Finally, an irreversible
and fatal case
of pulmonary hypertension
has been reported in a patient
who had seven 1-month courses of fenfluramine in the twelve years
prior to death. Patients taking fenfluramine should be advised to
report immediately any deterioration
in exercise tolerance.
Use only with caution in hypertension,
with monitoring of blood
pressure, since evidence
is insufficient to rule
out a possible adverse effect
on blood pressure in
some hypertensive
patients. The drug is not
recommended in severely hypertensive
patients. The drug is not
recommended for patients with symptomatic
cardiovascular
disease including arrhythmias.
Caution should be exercised in prescribing fenfluramine for patients
with a history of mental
depression. Further depression
of mood may become evident
while the patient is
on fenfluramine or following withdrawal
of fenfluramine. Symptoms of depression
occurring immediately following abrupt withdrawal can be readily
controlled by reinstituting Fenfluramine HCl, followed by a gradual
tapering off of the daily dose.
Information for the Patient
Fenfluramine may impair the ability
of the patient to engage
in potentially hazardous activities such
as operating machinery or driving a motor
vehicle (see ADVERSE REACTIONS);
the patient should be
cautioned accordingly. Patient should also be advised to avoid alcoholic
beverages while taking Fenfluramine HCl.
Carcinogenesis, Mutagenesis
No carcinogenic
studies or mutagenic studies have been undertaken with this drug.
Pregnancy Category C
Fenfluramine HCl was shown to produce a questionable embryotoxic
effect in rats and a reduced conception
rate when given in a dose
of 20 times the human
dose. However, additional reproduction
studies in rats, rabbits, mice, and monkeys at doses up to, respectively,
5 times, 20 times, 1 time, and 5 times the human
dose yielded negative
results.
There are no adequate and
well-controlled studies in pregnant
women. Fenfluramine HCl should be used during pregnancy
only if the potential benefit justifies the potential
risk to the fetus.
Labor and Delivery
The effect of fenfluramine
during labor or delivery
on the mother and the
fetus is unknown. The
effect on later growth,
development, and functional maturation of the child
is unknown.
Nursing Mothers
It is not known whether this drug
is excreted in human milk.
Because many drugs are excreted in human
milk, caution should be exercised when fenfluramine is administered
to a nursing mother.
Pediatric Use
Safety and effectiveness
in children below the age
of 12 years has not been established.
top
