Apo-Paroxetine Use In Pregnancy & Lactation

Pregnancy and Lactation: Although animal studies have not shown any teratogenic or selective embryotoxic effects, the safety of paroxetine in human pregnancy has not been established. APO-PAROXETINE should not be used during pregnancy unless the potential benefit to the patient outweighs the possible risk to the fetus.
Post-marketing reports indicate that some neonates exposed to PAROXETINE, SSRIs (Selective Serotonin Reuptake Inhibitors), or other newer anti-depressants late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of SSRIs and other newer anti-depressants, or possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome (see Postmarketing Reports under ADVERSE REACTIONS). When treating a pregnant woman with PAROXETINE during the third trimester, the physician should carefully consider the potential risks and benefits of treatment (see DOSAGE & ADMINISTRATION).
The concentrations of paroxetine detected in the breast milk of lactating women are similar to those in plasma. Lactating women should not nurse their infants while receiving paroxetine unless in the opinion of the treating physician, breast feeding is necessary, in which case the infant should be closely monitored.