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 Adverse Cases


Back Reported Adverse Drug Reaction Cases
Maternal SSRI use and neonatal effects
Maternal use of SSRIs during or after pregnancy may result in adverse effects in newborn babies, due to a withdrawal effect following intra-uterine exposure, or a toxic effect from ingestion of an SSRI in breast-milk.

ADRAC has received 26 reports of neonates with symptoms attributed to withdrawal effects due to maternal third trimester ingestion of SSRIs (paroxetine 10, sertraline 7, fluoxetine 7, citalopram 2). The table presents the most frequently reported reactions. Other reactions included convulsions, tremor, fever and respiratory disorders (respiratory depression, apnoea, tachypnoea). Two babies had marked extensor posturing with back-arching. The usual day of onset, if reported, was the day of birth, but ranged from 0 to 4 days of age. The symptoms resolved in 2-3 days in most cases.

Table: Frequent neonatal symptoms reported in association with maternal SSRI ingestion

Symptoms

Withdrawal syndrome

Breast-milk transfer

Agitation/Jitteriness

15

4

Poor feeding

7

4

Hypotonia

7

1

Sleepiness/Lethargy

0

3

Gastrointestinal symptoms

3*

3

Total reports

26

13

* In one case the symptoms may have been from breast-milk transfer.

In addition, 13 reports have been received of neonatal adverse effects probably resulting from breast-milk transfer of an SSRI (sertraline 9, paroxetine 2, fluoxetine 2). There was some overlap of the symptoms resulting from drug transfer into breast-milk and from drug withdrawal (see table). However, sleepiness was reported only with breast-milk transfer, and in two cases the baby slept for prolonged periods.

One study found that 12 (22%) of 55 neonates exposed to maternal paroxetine in the third trimester required prolonged hospitalisation for neonatal complications.1 The most common problem was respiratory distress (9), but two neonates had hypoglycaemia and one each had bradycardia, tachycardia, jaundice and feeding problems. None had underlying pathology and all recovered following a brief period of intensive intervention. In the same study, exposure to paroxetine through breastfeeding caused symptoms in 8 (22%) of 36 infants, with alertness (6), sleepiness (1) and irritability (1).

In adult users, withdrawal effects following paroxetine appear to be more likely than following use of other SSRIs, and hence neonatal withdrawal may be more likely with paroxetine, but this is yet to be demonstrated in comparative studies.2 However, paroxetine may have an advantage in breastfeeding since breast-milk transfer is proportionately lower than with fluoxetine or citalopram.3 One study in 11 infants detected sertraline in breast-milk but there were no adverse effects associated with exposure.4

It is probable that neonatal withdrawal effects would be minimised by using the lowest effective maternal dose, while breast-milk transfer can be treated by stopping or reducing the dose of SSRI, or by using formula milk.


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