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Pregnant Women: The safety of citalopram hydrobromide during pregnancy has not been established. Therefore, pms-CITALOPRAM should not be used during pregnancy, unless, in the opinion of the physician, the expected benefits to the patient markedly outweigh the possible risk to the fetus.
Complications following late third trimester exposure to SSRIs: Post-marketing reports indicate that some neonates exposed to SSRIs such as citalopram hydrobromide and other antidepressants 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 Neurologic: Serotonin Syndrome/Neuroleptic Malignant Syndrome (NMS)-Like Events under Precautions). When treating a pregnant woman with citalopram hydrobromide during the third trimester, the physician should carefully consider the potential risks and benefits of treatment (see Recommended Dose and Dosage Adjustment: Treatment of Pregnant Women under Dosage & Administration).
Risk of PPHN and exposure to SSRIs (including citalopram hydrobromide): Epidemiological studies on persistent pulmonary hypertension of the newborn (PPHN) have shown that the use of SSRIs (including citalopram) in pregnancy, particularly use in late pregnancy, was associated with an increased risk of PPHN. PPHN occurs in 1-2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. In a retrospective case-control study of 377 women whose infants were born with PPHN and 836 women whose infants were born healthy, the risk for developing PPHN was approximately six-fold higher for infants exposed to SSRIs after the 20th week of gestation compared to infants who had not been exposed to antidepressants during pregnancy (Odds Ratio 6.1, 95% CI 2.2-16.8). A study using data from the Swedish Medical Birth Register for 831,324 infants born in 1997-2005 found an increased risk of PPHN of approximately 2-fold associated with patient-reported maternal use of SSRIs in the first trimester of pregnancy (Risk Ratio 2.4, 95% CI 1.2-4.3), and an increased risk of PPHN of approximately 4-fold associated with a combination of patient-reported maternal use of SSRIs in the first trimester and an antenatal SSRI prescription in later pregnancy (Risk Ratio 3.6, 95% CI 1.2-8.3).
Nursing Women: The safety of citalopram hydrobromide during lactation has not been established. citalopram hydrobromide is excreted in human milk. pms-CITALOPRAM should not be administered to nursing mothers unless, in the opinion of the treating physician, the expected benefits to the patient markedly outweigh the possible risks to the child; in which case the infant should be closely monitored.
