Fact Sheet: Safety of Antidepressants in Pregnancy and Breastfeeding

Safety of antidepressants in
pregnancy and breastfeeding


What this fact sheet covers:
Risks of untreated depression in pregnancy and postnatally
Exposure to antidepressant drugs in pregnancy and during breastfeeding
Early pregnancy antidepressant exposure and birth defects and miscarriage
Late pregnancy exposure to SSRIs and risk of newborn withdrawal symptoms
(adaptation syndrome)
Exposure at any time in pregnancy to SSRIs and longer-term
neurobehavioural outcomes
Breastfeeding and antidepressants
Key points to remember
Where to get more information

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Introduction
Decisions about the use of antidepressants in pregnancy and breastfeeding need to be
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made with care. While this handout is designed to help you make an informed decision
about the use of antidepressants at this time, it is not meant to replace a detailed
discussion with your doctor. Furthermore, our knowledge in this area remains limited
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and new information is constantly coming to light on this topic. Ideally, discussions
with your doctor would take place before planning a pregnancy and, if possible, with
your partner present. The risks and benefits need to be weighed up before decisions
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can be made about stopping or (re)starting an antidepressant in pregnancy and when
breastfeeding.
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The risks of untreated depression in pregnancy and postnatally
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Depression in pregnancy and after childbirth occurs in about 10 percent of women.
When depression is severe, it may be associated with suicidal behaviour, poor
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self‐care, inadequate nutrition, excessive use of alcohol and cigarettes, and poor
antenatal clinic attendance. All of these can put the baby at risk. Some studies suggest
that maternal depression is associated with increased rates of prematurity, low birth
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weight and irritability in newborns. It is now thought that depression and anxiety in
pregnancy alter the hormonal environment in which the baby is developing with
possible longer term effects on both the physical and emotional health of the child.
Finally, women who cease antidepressants early in pregnancy or pre‐conception have
a five‐fold increased chance of relapse into depression by the time they deliver.
Mothers who are depressed after the birth will find it harder to adjust to parenting,
thus potentially impacting on their care of the baby and the mother‐baby relationship.

Exposure to antidepressants in pregnancy and breastfeeding
Together with considering the impact that untreated perinatal depression may have
on a woman, her developing infant and her relationship with her partner, the decision
to use medication during pregnancy and breastfeeding must also take into account any
possible risks associated with using antidepressant medication at this time.

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This fact sheet may be freely downloaded, copied or distributed on condition no change is made to the content. The information in
this fact sheet is not intended as a substitute for professional medical advice, diagnosis or treatment.

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Safety of antidepressants in
pregnancy and breastfeeding


Early pregnancy antidepressant exposure and birth defects and
miscarriage
1) Birth defects: There are now a number of studies examining several thousand
infants, suggesting that there is no increased risk of overall birth defects or
malformations above the general population risk of 2‐3%, with exposure during
pregnancy to the SSRI antidepressants (fluoxetine or Prozac, sertraline or Zoloft,
citalopram or Cipramil, escitalopram or Lexapro, and fluvoxamine or Luvox), as well as
the older tricyclic antidepressants (such as amitriptyline and dothiepin). There have
been some studies suggesting a possible increase in cardiac defects with the use of
paroxetine (Aropax) in pregnancy but this has not been substantiated in further
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studies.
The risk of birth defects with the SNRI venlafaxine (Efexor) is far less studied, but the
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small amount of data available would suggest it is not increased above the norm. Initial
studies on the use of mirtazapine (Avanza) during pregnancy have been reassuring
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with no increase in birth defects or other adverse outcomes.
2) Miscarriage and mild prematurity: There appears to be a slightly increased risk of
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first trimester miscarriage with the use of SSRI antidepressants. The background risk of
miscarriage for all pregnancies at this time is around 9%. SSRI antidepressant use early
in pregnancy increases this risk to around 12%.

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Neonatal withdrawal symptoms (adaptation syndrome)
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There have been reports of withdrawal symptoms in newborns exposed to
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antidepressants in the last few weeks of pregnancy.
The symptoms are usually mild, mostly begin on day one or within four days of birth,
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and usually last for two to three days. Newborns will initially need to be monitored in
hospital for such symptoms. These may include mild breathing problems, irritability,
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difficulty in settling and feeding, and ‐ very occasionally ‐ the baby may have a seizure.
There are no apparent long-term complications of neonatal adaptation syndrome and
no babies have died from late pregnancy antidepressant exposure.
More recent reports also suggest an increased, but minimal, chance of more severe
breathing problems (known as persistent pulmonary hypertension of the newborn)
with antidepressant exposure in late pregnancy. These problems are very rare and the
possible link with antidepressant medications is yet to be clarified.

As noted earlier, this is an evolving field of research and new information is continually
coming to light such that no definitive statements can be made about the absolute
safety of the antidepressant medications, whether exposure is early or late in
pregnancy.
Ultimately, the decision is made after discussion between the doctor and the patient
and her family, by balancing out the risks of untreated depression versus the impact of
these drugs on the developing baby.

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This fact sheet may be freely downloaded, copied or distributed on condition no change is made to the content. The information in
this fact sheet is not intended as a substitute for professional medical advice, diagnosis or treatment.

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Safety of antidepressants in
pregnancy and breastfeeding


Longer term neurobehavioural outcomes with exposure to
SSRIs/tricyclic antidepressants at any time in pregnancy
There are a small number of studies that have examined the impact of SSRI exposure
at any time in pregnancy on developmental milestones, as well as on cognitive and
behavioural functioning in pre-schoolers. None suggest any significant negative
impact. Much more research is needed in this area to allow more authoritative
conclusions but the data so far are encouraging. Similarly, long term follow-up of
children exposed to tricyclic antidepressants during pregnancy has not revealed any
adverse effect on their development.

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Breastfeeding and antidepressants

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There are many well-documented advantages to breastfeeding in the early months.
Together with the health benefits to the baby, breastfeeding can promote better
bonding between a mother and her infant, and increase a woman’s confidence in her
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overall ability to mother.
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The exposure of the infant to antidepressants through breastfeeding is far lower than
during pregnancy, with less than 5% of SSRIs passing into the breast milk. This is
generally too low to be of clinical significance and many women who have chosen to
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breastfeed while taking antidepressant medication have not reported any adverse
effects. A small number of studies available to date suggest that antidepressant use
while breastfeeding is not harmful in terms of the baby’s developmental milestones
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and pre-school performance.

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Key points to remember
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The decision to use antidepressant drugs during pregnancy and breastfeeding
needs to be made on an individual basis for each woman in collaboration with
her treating doctor and partner where possible.
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The risks to the baby of using medication must be weighed up against the risk
of untreated depression both for mother, infant and family.
Women who become pregnant while taking antidepressant medication should
consult their treating doctor before stopping the medication as the risk of
relapse of the depression may be high and the risks and benefits of continuing
the treatment throughout the pregnancy need to be carefully considered.





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This fact sheet may be freely downloaded, copied or distributed on condition no change is made to the content. The information in
this fact sheet is not intended as a substitute for professional medical advice, diagnosis or treatment.

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Safety of antidepressants in
pregnancy and breastfeeding


Where to get more information

If you have further queries you can call Mothersafe, a NSW state-wide telephone
service which allows you to discuss your concerns with staff who have expertise in this
area.
Phone: 02 9382 6539 or 1800 647 648.

See also our fact sheets: ‘Treatments for Bipolar Disorder during Pregnancy
and the Postnatal Period’ and ‘Depression during Pregnancy and the Postnatal
Period’. www.blackdoginstitute.org.au

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Black Dog Institute
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Hospital Road, Prince of Wales Hospital, Randwick NSW 2031
(02) 9382 4530 / (02) 9382 4523
www.blackdoginstitute.org.au
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Email: blackdog@blackdog.org.au
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This fact sheet may be freely downloaded, copied or distributed on condition no change is made to the content. The information in
this fact sheet is not intended as a substitute for professional medical advice, diagnosis or treatment.

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