Venlafaxine Pregnancy and Breastfeeding Warnings
Venlafaxine Pregnancy Warnings
Data reported on 150 women exposed to venlafaxine during pregnancy stated that 125 had live births, 18 had spontaneous abortions, and 7 had therapeutic abortions. Two of the babies had major malformations. There were no significant differences between these women and the two comparison groups on any of the measures analyzed. Neonates exposed to venlafaxine (and other SSRIs and SNRIs) late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Reported clinical findings have included respiratory distress, cyanosis, tachypnea, apnea, seizures, temperature instability, feeding difficulty, tachycardia, bradycardia, jaundice, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. (These features are consistent with either a direct toxic effect of SSRIs and SNRIs, or possibly a drug discontinuation syndrome.) In some cases, the clinical picture is consistent with serotonin syndrome. There are no controlled data in human pregnancy. Venlafaxine should be given during pregnancy and particularly during the third trimester, only if the potential benefits outweigh the potential risks to the fetus. If venlafaxine is used until or shortly before birth, discontinuation effects in the newborn should be considered. According to the results of a study, discontinuation effects typically appear during the first day of life and can last up to 5 days after birth. Symptoms were transient and self-limited in most cases. The results of a 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.
FDA pregnancy category: C Use venlafaxine only if clearly needed and benefit outweighs potential risk.
Venlafaxine Breastfeeding Warnings
A study of six breast-feeding mothers taking venlafaxine and their seven infants reported that the concentrations of venlafaxine and O-desmethylvenlafaxine in breast milk were 2.5 and 2.7 times those in maternal plasma. The mean total drug exposure (as venlafaxine equivalents) was reported to be 6.4%. There were no adverse effects reported for any of the infants. The authors stated that the data supported the use of venlafaxine in breast-feeding. However, since low concentrations of O-desmethylvenlafaxine were detected in the plasma of four of the seven infants studied, they recommended that the breast-fed infants be monitored closely. In one small case series (N=3) on the use of venlafaxine by breast-feeding mothers, the estimated mean dose the infants received from breast milk was 7.6% of the maternal weight-adjusted dose. No adverse effects were noted in the infant. However, the authors cautioned that this dose was high compared to the dose infants are estimated to receive when exposed to other antidepressants through breast milk. Two other infants have also been reported who received breast milk exclusively during their first six months from their mothers who were taking stable daily doses of venlafaxine. No adverse effects were reported. Venlafaxine was not detectable in either infant. The metabolite was present in both children at low concentrations. The authors felt that the presence of the metabolite suggested that these young infants were able to desmethylate the parent drug.
A decision should be made to discontinue breast-feeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes Excreted into animal milk: Unknown The effects in the nursing infant are unknown.
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