Pristiq Use In Pregnancy & Lactation

Pregnancy: Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy.
Teratogenic effects - Pregnancy Category C: Major depressive disorder.
When desvenlafaxine succinate was administered orally to pregnant rats and rabbits during the period of organogenesis, there was no evidence of teratogenicity in rats at any doses tested, up to 30 times on a mg/kg basis and up to 5 times the maximum recommended human dose (MRHD) of 200 mg/day (on a mg/m² basis) in rats. In rabbits, there was no evidence of teratogenicity at doses up to 23 times (on a mg/kg basis) the MRHD of 200 mg/day, or 7 times the MRHD (on a mg/m² basis). However, fetal weights were decreased in rats with a no-effect dose 30 times the MRHD (on a mg/kg basis) and 5 times the MRHD (on a mg/m² basis).
When desvenlafaxine succinate was administered orally to pregnant rats throughout gestation and lactation, there was a decrease in pup weights and an increase in pup deaths during the first four days of lactation. The cause of these deaths is not known. The no-effect dose for rat pup mortality was 30 times on a mg/kg basis and 5 times the MRHD of 200 mg/day (on a mg/m² basis). Post-weaning growth and reproductive performance of the progeny were not affected by maternal treatment with desvenlafaxine at a dose 90 times the MRHD (on a mg/kg basis) and 15 times the MRHD (on a mg/m² basis).
There are no adequate and well-controlled studies of PRISTIQ in pregnant women. Studies have demonstrated that desvenlafaxine crosses the human placenta. Therefore, PRISTIQ should be used during pregnancy only if the potential benefits justify the potential risks. If desvenlafaxine is used until, or shortly before birth, discontinuation effects in the newborn should be considered.
Data from the Quebec Pregnancy Cohort reported that, following exposure to SNRIs (including desvenlafaxine) during the second half of pregnancy, persistent pulmonary hypertension of the newborn (PPHN) was identified in 0.2% of all neonates; no statistical significance in the increased risk of PPHN in response to second/third trimester exposure could be established.
In a prospective, observational study, the median (interquartile range [IQR]) gestational age was higher in infants born to control mothers than those born to mothers treated with antidepressants (40 [39-40 weeks] vs. 39 [38-40 weeks]; p<0.05). Neonates born to control mothers also had a longer median (IQR) length at birth (51 [49-51.6] cm vs. 49 [47-51] cm; p<0.05) than infants born to mothers in the cases group. The infants also displayed mild behavioral anomalies, categorized as less optimal functioning for habituation and motor and autonomic clusters (using the Brazelton Neonatal Behavioral Assessment Scale [BNBAS]); however these events were self-limiting and usually resolved in 1 to 2 weeks.
In another study, 6 of the 7 neonates with in utero exposure to venlafaxine at near term had acceptable Apgar scores at birth; however an improvement in Apgar scores at 5 minutes was observed in all 7 neonates. No cases of intrauterine growth retardation were recorded. The adverse events observed in 5 neonates at birth, included respiratory distress, tachypnea, irritability, tremors, excessive suckling, rigidity, increased tonus, vomiting, hyper-reflexia, disorganized movements of limbs, initial decreased reactivity, agitation, poor sleep and liquid/abundant stool. In 4 of the 5 neonates, the events resolved spontaneously without the need for any pharmacological treatment, while one neonate required resuscitation and continuous positive airway pressure (C-PAP) for 48 hours. Although respiratory distress was attributed to the plasma concentration of venlafaxine or desvenlafaxine at birth, the occurrence of the other adverse events correlated with the declining levels of venlafaxine, suggests that these events could potentially signal withdrawal symptoms in the neonate following a decline in levels of venlafaxine after exposure to significantly high levels of the drug in utero.
A prospective longitudinal study of 201 women with a history of major depression who were euthymic at the beginning of pregnancy showed that women who discontinued antidepressant medication during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressant medication.
Exposure to SNRIs in mid to late pregnancy may increase the risk for preeclampsia, and exposure to SNRIs near delivery may increase the risk for postpartum hemorrhage.
Non-teratogenic effects: Neonates exposed to SNRIs or SSRIs (Selective Serotonin Reuptake Inhibitors), 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 SNRIs or, possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions under Precautions]. When treating a pregnant woman with PRISTIQ during the third trimester, the physician should carefully consider the potential risks and benefits of treatment [see Special Populations under Dosage & Administration].
Epidemiological data have suggested that the use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN). Although no studies have investigated an association of PPHN to SNRI treatment, this potential risk cannot be ruled out with desvenlafaxine taking into account the related mechanism of action (inhibition of the re-uptake of serotonin).
Labor and Delivery: The effect of PRISTIQ on labor and delivery in humans is unknown. PRISTIQ should be used during labor and delivery only if the potential benefits justify the potential risks.
Nursing Mothers: Desvenlafaxine (O-desmethylvenlafaxine) is excreted in human milk. No adverse events occurred in either the lactating mothers or the nursing infants, however, the effect in infants have not been established. PRISTIQ should only be taken by breastfeeding women if the expected benefits outweigh the possible risks.