Pregnancy & Lactation : הריון/הנקה

4.6       Pregnancy and lactation
Pregnancy
Animal studies have not shown any teratogenic or selective embryotoxic effects.
Recent epidemiological studies of pregnancy outcomes following maternal exposure to antidepressants in the first trimester have reported an increase in the risk of congenital malformations, particularly cardiovascular (e.g.
ventricular and atrial septal defects), associated with the use of paroxetine.
The data suggest that the risk of having an infant with a cardiovascular defect following maternal paroxetine exposure is approximately 1/50, compared with an expected rate for such defects of approximately 1/100 infants in the general population.
The prescribing physician will need to weigh the option of alternative treatments in women who are pregnant or are planning to become pregnant, and should only prescribe paroxetine if the potential benefit outweighs the potential risk. If a decision is taken to discontinue paroxetine treatment in a pregnant woman, the prescriber should consult 4.2 Posology and method of administration - Discontinuation of Paroxetine and 4.4 Special Warnings and Precautions for use
– Symptoms seen on discontinuation of paroxetine treatment in adults.
There have been reports of premature birth in pregnant women exposed to paroxetine or others SSRIs, although a causal relationship with drug therapy has not been established.
Neonates should be observed if maternal use of paroxetine continues into the later stages of pregnancy, becausethere have been reports of complications in neonates exposed to paroxetine or other SSRIs late in the third trimesterof pregnancy. However, a causal association with drug therapy has not been confirmed. Reported clinical findings have included: respiratory distress, cyanosis, apnoea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypertonia, hypotonia, hyperreflexia, tremor, jitteriness, irritability, lethargy, constant crying and somnolence. In some instances the reported symptoms were described as neonatal withdrawal symptoms. In a majority of instances the complications were reported to have arisen either immediately or soon (<24 hours) after delivery.
In one epidemiological study, the use of SSRIs (including paroxetine) after the first 20 weeks of pregnancy, wasassociated with an increased risk of persistent pulmonary hypertension of the newborn (PPHN). The absolute risk among those who used SSRIs late in pregnancy was reported to be about 6 to 12 per 1000 women, compared to 1 to 2 per 1000 women in the general population.
Lactation
Small amounts of paroxetine are excreted into breast milk. In published studies, serum concentrations in breast- fed infants were undetectable (<2 ng/ml) or very low (<4 ng/ml). No signs of drug effects were observed in these infants. Nevertheless, paroxetine should not be used during lactation unless the expected benefits to the mother justify the potential risks for the infant.