Category C: Paroxetine should not be used during pregnancy, unless the potential benefit outweighs the possible risk. The prescribing physician will need to weigh the option of alternative treatments in women who are pregnant or are planning to become pregnant.
If a decision is taken to discontinue Paroxetine treatment in a pregnant woman, the prescriber should consult Discontinuation of Paroxetine under Dosage & Administration and Symptoms seen on discontinuation of Paroxetine treatment in adults under Precautions.
Epidemiological studies have shown infants born to women who had first trimester Paroxetine exposure had an increased risk of cardiovascular malformations.
Neonates should be observed if maternal use of Paroxetine continues into the later stages of pregnancy, because there have been reports of complications in neonates exposed to Paroxetine 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, 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.