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Fertility: Some clinical studies have shown that SSRIs (including SEROXAT) may affect sperm quality. This effect appears to be reversible following discontinuation of treatment. Changes in sperm quality may affect fertility in some men.
Pregnancy: Animal studies have not shown any teratogenic or selective embryotoxic effects.
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 SEROXAT CR if the potential benefit outweighs the potential risk. If a decision is taken to discontinue SEROXAT CR treatment in a pregnant woman, the prescriber should consult Discontinuation of SEROXAT under Dosage & Administration and Symptoms seen on discontinuation of SEROXAT treatment in adults under Precautions.
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.
Observational data have provided evidence of an increased risk (less than two-fold) of postpartum haemorrhage following exposure to SSRIs within one month prior to birth.
Neonates should be observed if maternal use of SEROXAT continues into the later stages of pregnancy, because there have been reports of complications in neonates exposed to SEROXAT or other SSRIs late in the third trimester of 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, hypoglycaemia, 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.
Epidemiological studies have shown that the use of SSRIs (including paroxetine) in pregnancy, particularly use in late pregnancy, was associated with an increased risk of persistent pulmonary hypertension of the newborn (PPHN). The increased risk among infants born to women who used SSRIs late in pregnancy was reported to be four to five times higher than observed in the general population (rate of 1 to 2 per 1000 pregnancies).
Lactation: Small amounts of paroxetine are excreted into breast milk. In published studies, serum concentrations in breast-fed infants were undetectable (<2 nanograms/mL) or very low (<4 nanograms/mL). No signs of drug effects were observed in these infants.
Nevertheless, SEROXAT should not be used during lactation unless the expected benefits to the mother justify the potential risks for the infant.
