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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5238_Библиотеки_им_академика_М_И_Перельмана.pdf
7 Antidepressants During Lactation
149
2022). Therefore, pregnant women or nursing mothers using ADs may benet from
breastfeeding support that could be more specic (e.g., trained staff, early and individualized support, advice on AD safety during breastfeeding…), to help them
reach better breastfeeding outcomes.
Second, this review with safety score update highlights that all ADs assessed
can be prescribed to breastfeeding mothers, although the safety proles of these
drugs vary. Table7.1 summarizes this document’s recommendations concerning
AD use during breastfeeding. Both sertraline and paroxetine ranked high, which
aligns with international guidelines recommending them as preferred ADs during breastfeeding (Molenaar etal. 2018; Portet etal. 2024). However, other ADs
ranked from high to very low, with many guidelines providing no or contradictory information. For such cases, North American and European guidelines indicate that AD prescription involves an individualized risk-benet assessment
(AAP and ACOG 2015; Kittel-Schneider etal. 2022; Sriraman etal. 2015). The
Academy of Breastfeeding Medicine suggests that a previously effective AD
should be rst-line represcribed to a breastfeeding mother, and that an effective
AD during pregnancy should be continued during breastfeeding (Sriraman etal.
2015). Similarly, the American Academy of Pediatrics and American College of
Obstetricians and Gynecologists recommend to not switch an effective AD to
another AD because of breastfeeding, but to continue the AD with close monitoring of the infant’s growth and neurodevelopment (AAP and ACOG 2015). In
addition, the risk-benet assessment should consider the substantial benets of
breastfeeding for both mother and child, including on mental maternal health
(Henshaw 2023; Kendall-Tackett etal. 2011).
Third, although AD transfer to infants via breastmilk is lower than transplacental
transfer during pregnancy (Schoretsanitis etal. 2021), the potential adverse reactions of AD exposure in breastfed children have been studied far less extensively
compared to the numerous studies conducted during pregnancy, raising concerns.
However, data from the U.S.Food and Drug Administration (FDA) Adverse Event
Reporting System (FAERS) indicate that nervous system drugs account for half of
the adverse drug reactions reported in breastfed infants (Yalçın etal. 2024). The
overall methodological quality of lactation studies on ADs has been deemed insufcient (Den Besten-Bertholee etal. 2019). Most of the included studies in this chapter were small cohorts or case report studies, which may induce selection bias or
reporting biases. Some researchers advocate for the establishment of populationbased databases to monitor neurodevelopment in children exposed to ADs via
breastfeeding (Nallani etal. 2023). In response to these gaps, the FDA has issued
draft guidance encouraging pharmaceutical companies to conduct clinical lactation
studies on ADs (FDA 2019).
150
Comments on
usage during
breastfeeding
Possible
main recommendations
®
(drowsiness, fussiness). If citalopram is
Safety
prole LactMed
required by the mother, it is not a reason
to discontinue breastfeeding. Continue
citalopram if started during pregnancy or
if other ADs have been ineffective;
otherwise, prefer ADs with lower
excretion into breastmilk (especially
with newborns or preterm infants).
Monitor the infant for excess drowsiness,
restlessness, irritability, poor feeding,
and poor weight gain (especially in
younger, exclusively breastfed infants, or
psychotropic drugs combined)
P. Desaunay et al.
Possible with
caution
enterocolitis, case of seizure-like event,
and cases of minor behavioral problems.
If escitalopram is required by the
mother, it is not a reason to discontinue
breastfeeding. Monitor the infant for
excess drowsiness, restlessness,
agitation, poor feeding, and poor weight
gain (especially in younger, exclusively
breastfed infants, or psychotropic drugs
combined)
Safety scores
Adverse
Maximum
Table 7.1 Expert recommendations based on scientic evidence and clinical experience
Total
0–10
F
0–1
E
0–2
D
0–1
C
0–1
B
0–2
A
0–2
reactions
in infants
reported
RID
Antidepressant
class and drug
Selective serotonin reuptake inhibitors
Citalopram 18.4% 9% 2.5 0.5 1 0.5 1 1 6.5 Moderate Reported cases of minor side effects
Escitalopram 9% 22% 2 1 1 0.5 0.5 0 5 Low Reported case of necrotizing
7 Antidepressants During Lactation
Comments on
usage during
breastfeeding
Possible
main recommendations
®
Reported cases as colic, fussiness, and
drowsiness in some infants. If uoxetine
is required by the mother, it is not a
reason to discontinue breastfeeding.
Continue uoxetine if started during
pregnancy or if other ADs have been
ineffective; otherwise, prefer ADs with
Safety
prole LactMed
Possible
lower excretion into breastmilk
(especially with newborns or preterm
infants). Monitor the infant for colic,
agitation, irritability, poor feeding, poor
weight gain
diarrhea, vomiting, and stimulation.
Maternal uvoxamine up to 300mg
daily would cause any adverse effects. If
the mother requires uvoxamine, it is
not a reason to discontinue
breastfeeding. Monitor the infant for
diarrhea, vomiting, decreased sleep, and
agitation
151
(continued)
Total
0–10
F
0–1
E
0–2
D
0–1
C
0–1
B
0–2
A
0–2
Safety scores
Adverse
reactions
in infants
Maximum
reported
RID
Antidepressant
class and drug
Fluoxetine 20% 12% 3 0.5 1 0.5 1 0 6 Moderate High amount of drug in breastmilk.
Fluvoxamine 1.38% 5% 1.5 2 0.5 1 1 1 7 Moderate Limited information. Reported case of
152
Comments on
usage during
breastfeeding
Acceptable
main recommendations
®
small amounts ingested by the infant,
mostly not detected in the infant’s
Safety
prole LactMed
Acceptable
serum. Occasional mild side effects
reported (especially after in utero
exposure during the third trimester of
pregnancy). A preferred AD during
breastfeeding. Monitor the infant for
agitation, irritability, poor feeding, and
poor weight gain
small amounts ingested by the infant,
usually not detected in the infant’s serum
P. Desaunay et al.
Not
recommended
(although active metabolite often
detected in low levels). Rare symptoms,
similar to neonatal abstinence, in
preterm infants. A preferred AD during
breastfeeding
is approximately half that of breastfed
infants exposed to venlafaxine via
breastmilk transfer. Monitor breastfed
infants for excessive sedation and
adequate weight gain if this drug is used
during lactation, especially newborns or
preterm infants
Total
F
E
D
C
B
A
Safety scores
Adverse
reactions
Maximum
reported
Antidepressant
Table 7.1 (continued)
0–10
0–1
0–2
0–1
0–1
0–2
0–2
in infants
RID
class and drug
Paroxetine 3.2% 9% 3 1.5 1 1 1 0 7.5 Good Low levels of paroxetine in breastmilk,
Sertraline 2.4% 8% 3 1.5 1 1 1 1 8.5 Good Low levels of sertraline in breastmilk,
Serotonin and norepinephrine reuptake inhibitors
Desvenlafaxine 10.8% 63% 1 0.5 0.5 0 0 1 3 Very low Total drug exposure of breastfed infants
7 Antidepressants During Lactation
Comments on
usage during
breastfeeding
Possible with
caution
main recommendations
®
the dose in milk is low and serum levels
are low. If the mother requires
duloxetine, it is not a reason to
discontinue breastfeeding. A better
studied drug may be preferred,
especially while nursing a newborns or
preterm infant. Monitor breastfed infants
Safety
prole LactMed
Not
recommended
for drowsiness, adequate feeding, weight
gain and developmental milestones
(especially in younger, exclusively
breastfed infants, or psychotropic drugs
combined)
are low and would not be expected to
cause any adverse effects in breastfed
infants. Until more data become
available, milnacipran should be used
with caution during breastfeeding
153
(continued)
(especially in newborn or preterm infant)
Total
0–10
F
0–1
E
0–2
D
0–1
C
0–1
B
0–2
A
0–2
Safety scores
Adverse
reactions
in infants
Maximum
reported
RID
Antidepressant
class and drug
Duloxetine 0.82% 33% 1 2 0.5 0.5 0 0.5 4.5 Low Little published information; however,
Milnacipran 5% ND 1 1.5 0.5 0 0 0 3 Very low Amounts of milnacipran in breastmilk
154
Comments on
usage during
breastfeeding
Possible with
caution
main recommendations
®
in the plasma of most breastfed infants;
however, concurrent side effects have
Safety
prole LactMed
Possible with
caution
rarely been reported. Monitor breastfed
infants for excessive sedation and
adequate weight, especially in newborns
or preterm infants, or even measure
serum levels of desvenlafaxine
(O-desmethylvenlafaxine), to rule out
toxicity if there is a concern. Bruxism
has been reported in one infant
metabolites in breastmilk. Limited data
found no adverse effects on infant
growth and development. Amitriptyline
P. Desaunay et al.
use during breastfeeding would usually
not be expected to cause any adverse
effects in breastfed infants, especially if
the infant is older than 2months. Rare
sedation has been reported in a neonate.
Other agents with fewer active
metabolites may be preferred when large
doses are required or while nursing a
Possible
newborn or preterm infant
clomipramine during breastfeeding is
acceptable
Total
F
E
D
C
B
A
Safety scores
Adverse
reactions
Maximum
reported
Antidepressant
Table 7.1 (continued)
0–10
0–1
0–2
0–1
0–1
0–2
0–2
in infants
RID
class and drug
Venlafaxine 13.3% 9.4% 2 0.5 1 0.5 1 0 5 Low Metabolite of venlafaxine can be found
TCAs
Amitriptyline 1.8% 5.2% 1.5 2 0 1 1 0 5.5 Low Low levels of amitriptyline and its
Clomipramine 2.2% 0% 1.5 1.5 0 1 2 1 7 Moderate Limited evidence indicates that use of
7 Antidepressants During Lactation
Comments on
usage during
breastfeeding
Not
recommended
main recommendations
®
drowsiness and developmental concerns
in one infant, but no problems in 16
other breastfed infants. Infant exposure
and adverse effects can be avoided if
breastfeeding is held for 4hours after a
Safety
prole LactMed
Possible with
caution
dose
bupropion doses of up to 300mg daily
produce low levels in breastmilk and
would not be expected to cause any
adverse effects. Reported case of a
possible seizure. If bupropion is required
by a nursing mother, it is not a reason to
discontinue breastfeeding. However,
another drug may be preferred
(especially with newborns or preterm
infants). For bupropion co-prescribed
with an SSRI, monitor for vomiting,
diarrhea, jitteriness, sedation, or even
measure serum levels to rule out toxicity
if there is a concern
155
(continued)
Total
0–10
F
0–1
E
0–2
D
0–1
C
0–1
B
0–2
A
0–2
Safety scores
Adverse
reactions
in infants
Maximum
reported
RID
Antidepressant
class and drug
Other antidepressant drugs
Agomelatine ND 5.8% 1.5 0 0 0 1 0 2.5 Very low Little published information; possible
Bupropion 10.6% 23.7% 2 0.5 0.5 1 0.5 0 4.5 Low Limited information. Maternal
156
Comments on
usage during
breastfeeding
Possible with
caution
main recommendations
®
form of milnacipran has low levels in
breastmilk and would not be expected to
Safety
prole LactMed
Possible with
caution
cause any adverse effects. Until more
data become available, levomilnacipran
should be used with caution during
breastfeeding (especially in newborns
and preterm infants). Monitor for
agitation, irritability, poor feeding, and
poor weight gain
would not be expected to cause any
adverse effects in breastfed infants. Until
P. Desaunay et al.
Acceptable
more data become available, milnacipran
should be used with caution during
breastfeeding (especially in newborns
and preterm infants)
up to 120mg daily produce low levels in
milk and would not be expected to cause
any adverse effects, especially if the
infant is older than 2months. If
mirtazapine is required by the mother, it
is not a reason to discontinue
breastfeeding. Monitor exclusively
breastfed infants for behavioral side
effects and adequate growth
Total
F
E
D
C
B
A
Safety scores
Adverse
reactions
Maximum
reported
Antidepressant
Table 7.1 (continued)
0–10
0–1
0–2
0–1
0–1
0–2
0–2
in infants
RID
class and drug
Levomilnacipran ND ND No information. However, the racemic
Milnacipran 5% ND 1 1.5 0.5 0 0 0 3 Low Low amounts in milk; milnacipran
Mirtazapine 2.8% 0% 2 1.5 0.5 1 2 1 8 Good Limited information; maternal doses of
7 Antidepressants During Lactation
Comments on
usage during
breastfeeding
Not
recommended
main recommendations
®
nefazodone produce low but variable
levels in milk that would not be expected
to cause adverse effects, especially if the
infant is older than 2months. Reported
adverse effects in a preterm infant. If
nefazodone is required by the mother of
an older infant, it is not a reason to
Safety
prole LactMed
Not
recommended
discontinue breastfeeding. Until more
data become available, other drugs may
be preferred (especially with newborns
or preterm infants)
10mg daily produce low levels in milk
and appear to not result in any adverse
effects in breastfed infants. Until more
data are available, reboxetine should be
Possible with
caution
used with careful monitoring during
breastfeeding
low and would not be expected to cause
157
(continued)
any adverse effects, especially if the
infant is older than 2months or when
doses of 100mg or less are used at
bedtime for sleep
Total
0–10
F
0–1
E
0–2
D
0–1
C
0–1
B
0–2
A
0–2
Safety scores
Adverse
reactions
in infants
Maximum
reported
RID
Antidepressant
class and drug
Nefazodone 6.2% ND 0.5 1 0 0 0 0 1.5 Very low Limited information; usual doses of
Reboxetine 2.5% ND 1 1.5 0 0.5 0.5 0.5 3 Very low Limited information; doses of up to
Trazodone 0.65% ND 1 2 0.5 0 0.5 0.5 4.5 Low Limited information; levels in milk are
158
Comments on
usage during
breastfeeding
Not
recommended
main recommendations
®
be preferred, especially while nursing
newborns or preterm infants
Safety
prole LactMed
Possible with
caution
If vortioxetine is required by the mother,
it is not a reason to discontinue
breastfeeding. Until more data are
available, vortioxetine should be used
with careful infant monitoring during
breastfeeding
Possible with
caution
bioavailability; brexanolone would not
be expected to cause any adverse effects
in breastfed infants. If brexanolone is
P. Desaunay et al.
required by the mother, it is not a reason
to discontinue breastfeeding. Because
excessive sedation or sudden loss of
consciousness can occur during
brexanolone infusion, patients should
provide a separate caregiver for any
child who is present during the infusion
Total
F
E
D
C
B
A
Safety scores
Adverse
reactions
Maximum
reported
Antidepressant
Table 7.1 (continued)
0–10
0–1
0–2
0–1
0–1
0–2
0–2
in infants
RID
class and drug
Vilazodone ND ND No information. An alternate drug may
Vortioxetine 1.7% ND 0.5 2 0 0 0.5 0.5 3.5 Low Amounts of vortioxetine in milk are low.
Neurosteroid agents
Brexanolone 1.3% ND 1 2 0.5 0 0 0 3.5 Low Low amounts in milk and low oral