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Pregnant Women: There are no adequate and well-controlled clinical studies on the use of fluoxetine in pregnant women. pms-FLUOXETINE should not be administered to pregnant women or those intending to become pregnant unless in the opinion of the treating physician, the expected benefits to the patient markedly outweigh the possible hazards to the fetus or the child. See Effects on Newborns as follows; Special Patient Populations: Use in Pregnant Women under Dosage & Administration.
Effects on Newborns: Results of a number of epidemiological studies of pregnancy outcomes following early maternal exposure to antidepressants have been inconsistent, but there is some evidence of a possible small increase in the risk of cardiac malformations (e.g. ventricular and septal defects) associated with use of fluoxetine. The mechanism is unknown. The use of pms-FLUOXETINE during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus taking into account the risks associated with untreated depression. See Possible Risk of Cardiovascular Malformations following first trimester exposure to SSRIs as follows.
Post-marketing reports indicate that some neonates exposed to fluoxetine, other SSRIs (selective serotonin reuptake inhibitors), or 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. When treating a pregnant woman with pms-FLUOXETINE during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. See Complications following late third trimester exposure to SSRIs as follows; Special Patient Populations: Use in Pregnant Women under Dosage & Administration.
Possible Risk of Cardiovascular Malformations following first trimester exposure to SSRIs: Results of a number of epidemiological studies of pregnancy outcomes following early maternal exposure to antidepressants have been inconsistent, with some finding no increased risk of malformations with fluoxetine exposure, while others have found a small increased risk for cardiovascular malformations (e.g. ventricular and septal defects) in infants with first trimester exposure to fluoxetine compared to those not exposed. The mechanism is unknown. Overall, the data suggest that the potential risk of having an infant with a cardiovascular malformation following maternal exposure to fluoxetine is less than 2/100 compared with an expected rate for such defects of approximately 1/100 in the general population. The use of pms-FLUOXETINE during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus taking into account the risks associated with untreated depression.
Complications following late third trimester exposure to SSRIs: Post-marketing reports indicate that some neonates exposed to fluoxetine, other SSRIs (selective serotonin reuptake inhibitors), or 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 Monoamine Oxidase Inhibitors under Contraindications). When treating a pregnant woman with pms-FLUOXETINE during the third trimester, the physician should carefully consider the potential risks and benefits of treatment (see Special Patient Populations: Use in Pregnant Women under Dosage & Administration).
Risk of PPHN and exposure to SSRIs (including fluoxetine): Exposure during late pregnancy to SSRIs, including fluoxetine, may have an increased risk for persistent pulmonary hypertension of the newborn (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. A study of 831 324 infants born in Sweden in 1997-2005 found a PPHN risk ratio of 2.4 (95% CI 1.2-4.3) associated with patient-reported maternal use of SSRIs in "early pregnancy" and a PPHN risk ratio of 3.6 (95% CI 1.2-8.3) associated with a combination of patient-reported maternal use of SSRIs in "early pregnancy" and an antenatal SSRI prescription in "later pregnancy".
Nursing Women: Fluoxetine and its metabolites are excreted in breast milk, and have been observed to reach high levels in the plasma of nursing infants. Women who are taking pms-FLUOXETINE should not breast feed unless, in the opinion of the treating physician, breast feeding is necessary, in which case the infant should be closely monitored.
In one breast milk sample, the concentration of fluoxetine plus norfluoxetine was 70.4 ng/mL. The concentration in the mother's plasma was 295.0 ng/mL. No adverse effects on the infant were reported. In another case, a 6-week infant, nursed by a mother on fluoxetine, developed crying, decreased sleep, vomiting and watery stools. The breast milk showed concentrations of 69 ng/mL for fluoxetine and 90 ng/mL for norfluoxetine. In the infant's plasma, the concentrations of fluoxetine and norfluoxetine on the second day of feeding were 340 and 208 ng/mL, respectively.
