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Prozac (fluoxetine) |
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General Pregnancy Information
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.
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FDA Pregnancy Categories The FDA-assigned pregnancy categories as used in the Drug Formulary are as follows: Category A Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters). Category B Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. 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. Category D There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Category X Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits. Drug Category
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