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
• Exposure at any time in pregnancy to SSRIs and longer‐term neurobehavioural
• Breastfeeding and antidepressants• Key points to remember
Introduction Deciding about the use of antidepressants in pregnancy and breastfeeding needs to be made with care. We recommend a detailed discussion with your doctor when making this decision. Ideally, you would speak with your doctor about this issue before planning a pregnancy and if possible, with your partner present. The risks and benefits need to be weighed up before decisions can be made about stopping or (re)starting an antidepressant in pregnancy and while breastfeeding. The risks of untreated depression in pregnancy and postnatally 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 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 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.
This document may be freely downloaded and distributed on condition no change is made to the content.
The information in this document is not intended as a substitute for professional medical advice, diagnosis
or treatment. Not to be used for commercial purposes and not to be hosted electronically outside of the
Black Dog Institute website. Updated October 2012. Safety of antidepreSSantS in pregnancy and breaStfeeding Early pregnancy antidepressant exposure, birth defects and miscarriage 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 studies.
The risk of birth defects with the SNRI venlafaxine (Efexor) is far less studied, but the 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 with no increase in birth defects or other adverse outcomes. Miscarriage and mild prematurity: There appears to be a slightly increased
risk of first trimester miscarriage with the use of SSRI antidepressants. The background risk ofmiscarriage for all pregnancies at this time is around 9%. SSRI antidepressant use early in pregnancy increases this risk to around 12 %.
Neonatal Withdrawal Symptoms (Adaptation Syndrome) There have been reports of withdrawal symptoms in newborns exposed to antidepressants in the last few weeks of pregnancy. The symptoms are usually mild, mostly begin on day one or within four days of birth, 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, 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.
Breathing problems & ‘Persistent Pulmonary Hypertension of the Newborn’ Some babies have a very uncommon but significant condition called ‘Persistent Pulmonary Hypertension of the Newborn’ (PPHN) which is associated with breathing problems in the newborn. The background risk for this condition is around 1.5 in a 1000 newborns . It seems that SSRI antidepressant use in pregnancy may be associated with an increased risk of around 3 in 1000 (Kieler et al, 2012).
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
This document may be freely downloaded and distributed on condition no change is made to the content.
The information in this document is not intended as a substitute for professional medical advice, diagnosis
or treatment. Not to be used for commercial purposes and not to be hosted electronically outside of the
Black Dog Institute website. Updated October 2012. Safety of antidepreSSantS in pregnancy and breaStfeeding
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
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 tricyclics antidepressants during pregnancy has not revealed any adverse effect on their development. Breastfeeding and antidepressants 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 overall ability to mother.
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 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 and preschool performance. Key points to remember • 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
• 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
This document may be freely downloaded and distributed on condition no change is made to the content.
The information in this document is not intended as a substitute for professional medical advice, diagnosis
or treatment. Not to be used for commercial purposes and not to be hosted electronically outside of the
Black Dog Institute website. Updated October 2012. Safety of antidepreSSantS in pregnancy and breaStfeeding Where to get more information • Kieler H., Artama M., Engeland A., Ericsson O., Furu K., Gissler M., Nielsen R.B., Nørgaard
M., Stephansson O., Valdimarsdottir U., Zoega H. and Haglund B. (2012). Selective serotonin reuptake inhibitors during pregnancy and risk of persistent pulmonary hypertension in the newborn: population based cohort study from the five Nordic countries. BMJ 2012;344:d8012 • 1800 011 511 Mental Health Line is a NSW Government phone service operating
24 hours a day, seven days a week and will provide a telephone triage assessment and
referral service staffed by mental health clinicians.
• Mothersafe is a NSW state-wide telephone service which allows you to discuss your
concerns with staff who have expertise in this area. Ph: 02 9382 6539 or 1800 647 848
• www.motherisk.org is a leading website for information about drugs in pregnancy
and breastfeeding and can be consulted for frequent updates
Black Dog Institute Hospital Road, Prince of Wales Hospital, Randwick NSW 2031 (02) 9382 4530 Email: blackdog@blackdog.org.au www.blackdoginstitute.org.au
This document may be freely downloaded and distributed on condition no change is made to the content.
The information in this document is not intended as a substitute for professional medical advice, diagnosis
or treatment. Not to be used for commercial purposes and not to be hosted electronically outside of the
Black Dog Institute website. Updated October 2012.
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