Fluoxetine Pregnancy and Breastfeeding Warnings
Fluoxetine Pregnancy Warnings
Animal studies have failed to reveal evidence of teratogenicity. In a postmarketing report, outcome data were available for 723 pregnancies, 476 normal live births, 20 premature births, 105 therapeutic abortions, 81 spontaneous abortions, 14 twin pregnancies without malformations, three stillbirths, 14 perinatal major malformations, and 10 postperinatal malformations were reported. Fluoxetine is only recommended for use during pregnancy when benefits outweigh risk. Neonates exposed to fluoxetine and other SSRIs or SNRIs late in the third trimester have developed complications requiring hospitalization, respiratory support, and tube feeding. The results of a cohort study indicate that 30% of neonates who had prolonged exposure to SSRIs in utero experience symptoms, in a dose-response manner, of a neonatal abstinence syndrome (e.g., tremor, gastrointestinal or sleep disturbances, hypertonicity, high-pitched cry) after birth. The authors suggest that infants exposed to SSRIs should be closely monitored for a minimum of 48 hours after birth. Based on the results of a retrospective case-controlled study, the manufacturer states that infants exposed to SSRIs after the 20th week of gestation may have a six-fold higher risk for developing persistent pulmonary hypertension of the newborn (PPHN) compared with infants who had not been exposed. It should be noted that PPHN is associated with significant neonatal morbidity and mortality. However, evidence from additional studies is warranted in order to confirm these findings. A prospective study compared the outcome of 228 pregnant women taking fluoxetine to 254 pregnant control women. The rates of spontaneous pregnancy loss were 10.5% and 9.1% respectively. The rates of major structural abnormalities were 5.5% and 4.0%. The incidence of three or more minor anomalies was significantly higher in exposed infants (15.5% vs. 6.5%). Infants exposed during the third trimester had high rates of premature delivery, admission to special care nurseries, and poor neonatal adaptation (including respiratory difficulty, cyanosis on feeding and jitteriness). Infants exposed late in gestation had shorter birth lengths and lower birth weights. One author has pointed out that he feels a problem with the above study was the absence of a relevant control group. Higher rates of perinatal complications, including lower birth weight, neonatal distress and prematurity, have been described in the offspring of mothers with mood and anxiety disorders who did not take any psychotropic drug during pregnancy. Furthermore, he points out that women who continued to take fluoxetine into the third trimester probably had more severe psychiatric illnesses. Another prospective study of 128 pregnant women exposed to a mean daily dose of 25.8 mg of fluoxetine during the first trimester reported no increase in the frequency of major malformations compared to two groups of control patients. (One control group received tricyclic antidepressants. The other control group received nonteratogens.) However, women exposed to fluoxetine and tricyclic antidepressants did demonstrate an increased frequency of miscarriage (13.5% and 12.2% compared to 6.8% in women exposed to nonteratogens.) One last prospective study compared rates of neonatal complications from 112 pregnant women taking fluoxetine and the 115 infants they delivered to the National Hospital Discharge Survey. The study concluded it was unlikely that maternal fluoxetine use during the third trimester results in significant postnatal complications. FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
FDA pregnancy category: C Fluoxetine is only recommended for use during pregnancy when there are no alternatives and benefits outweigh the risks.
Fluoxetine Breastfeeding Warnings
Use of fluoxetine is not recommended. Excreted into human milk: Yes Excreted into animal milk: Data not available The effects in the nursing infant are unknown.
Fluoxetine is described by the American Academy of Pediatrics as a drug whose "effect on nursing infants is unknown but may be of concern". A report of ten women nursing eleven infants found that less than 10% of the dose of fluoxetine (per kg of body weight) was delivered to the nursing infant during chronic maternal therapy. Other reports from two lactating women taking fluoxetine have described milk fluoxetine and norfluoxetine concentrations to be about one-fifth to one-quarter serum concentrations. No adverse effects were reported in any of the nursing infants above.
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