Is Fluvoxaminum Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use Fluvoxaminum? Is Fluvoxaminum safe for nursing mother and child? Does Fluvoxaminum extracts into breast milk? Does Fluvoxaminum has any long term or short term side effects on infants? Can Fluvoxaminum influence milk supply or can Fluvoxaminum decrease milk supply in lactating mothers?

It is excreted into breast milk in non-significant amount. Plasma level in infants from mother who receive Fluvoxaminum is usually undetectable. Not effects on the infant's physical and psychomotor development at both short or long-term were found. Because there is less experience published than with other antidepressants of the same pharmacological group, it should be preferred the use of an alternative drug that is known to be safer in the neonatal period or prematurity. Galactorrhea has been observed but less frequently than with other antidepressants. In cases of treatment with xanthines (theophylline, caffeine) for apnea of prematurity, the plasma level of them should be monitored because Fluvoxaminum is a strong inhibitor of activity of the Cytochrome P450-CYP1A2 which is responsible for metabolic elimination of xanthines. Women who use antidepressant medication during pregnancy are in need of more support for breastfeeding since they are at risk for early weaning.

Limited information indicates that maternal Fluvoxaminum doses of up to 300 mg daily produce low levels in breastmilk and would not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months. One infant was reported to have an elevated serum level of Fluvoxaminum, but most who have been tested have undetectable serum levels. Another infant developed diarrhea, vomiting and stimulation after maternal initiation of Fluvoxaminum. A limited amount of long-term follow-up on growth and development has found no adverse effects in breastfed infants. Mothers taking an SSRI during pregnancy and postpartum may have more difficulty breastfeeding, although this might be a reflection of their disease state.[1] These mothers may need additional breastfeeding support. Breastfed infants exposed to an SSRI during the third trimester of pregnancy have a lower risk of poor neonatal adaptation than formula-fed infants.

One infant whose mother began taking Fluvoxaminum 100 mg daily 17 weeks postpartum was breastfed from birth to 5 months of age. The medical and nursing staff did not note any adverse effect in the infant during the 10 weeks of observation during maternal hospitalization. The infant had normal Bayley developmental scores at age 4 months and 21 months.[7] No adverse effects were found in 2 infants, a partially breastfed 26-month-old during maternal intake of 150 mg daily, who also had a normal Denver Developmental Score, and an exclusively breastfed 3-week-old during maternal intake of 50 mg daily.[3] Three mothers who took an average Fluvoxaminum dose of 117 mg once daily breastfed their infants exclusively for 4 months and at least 50% during months 5 and 6. Their infants had 6-month weight gains that were normal according to national growth standards and the mothers reported no abnormal effects in their infants.[8] One study of the side effects of SSRI antidepressants in nursing mothers found no adverse reactions that required medical attention in one infant whose mother was taking Fluvoxaminum. No specific information on maternal Fluvoxaminum dosage, extent of breastfeeding or infant age was reported.[9] A woman who was treated chronically with quetiapine 400 mg and Fluvoxaminum 200 mg daily took the drugs throughout pregnancy and postpartum. She partially breastfed her infant (extent not stated) for 3 months from birth. No adverse events were seen in the infant who developed normally.[10] A cohort of 247 infants exposed to an antidepressant in utero during the third trimester of pregnancy were assessed for poor neonatal adaptation (PNA). Of the 247 infants, 154 developed PNA. Infants who were exclusively given formula had about 3 times the risk of developing PNA as those who were exclusively or partially breastfed. Four of the infants were exposed to low doses of Fluvoxaminum in utero and none had PNA.[11] A 5-month-old infant developed severe diarrhea (15 times daily), mild vomiting (2 to 3 times daily), agitation and decreased sleep within 2 days after maternal initiation of Fluvoxaminum 50 mg daily. Symptoms resolved within 24 hours after the mother discontinued the drug, and recurred a week later after Fluvoxaminum was restarted in the mother. Other causes of the gastrointestinal symptoms could not be found. Fluvoxaminum was probably the cause of the reaction. The authors speculate that the infant might have abnormal metabolism of the drug that resulted in high serum concentrations.[12]

Fluvoxaminum has caused increased prolactin levels and galactorrhea in nonpregnant, nonnursing patients.[13][14][15] In one case, euprolactinemic gynecomastia and galactorrhea occurred in a 19-year-old man who was also taking risperidone.[16] In a study of cases of hyperprolactinemia and its symptoms (e.g., gynecomastia) reported to a French pharmacovigilance center, Fluvoxaminum was found to have a 4.5-fold increased risk of causing hyperprolactinemia compared to other drugs.[17] The prolactin level in a mother with established lactation may not affect her ability to breastfeed. In a small prospective study, 8 primiparous women who were taking a serotonin reuptake inhibitor (SRI; 3 taking fluoxetine and 1 each taking citalopram, duloxetine, escitalopram, paroxetine or sertraline) were compared to 423 mothers who were not taking an SRI. Mothers taking an SRI had an onset of milk secretory activation (lactogenesis II) that was delayed by an average of 16.7 hours compared to controls (85.8 hours postpartum in the SRI-treated mothers and 69.1 h in the untreated mothers), which doubled the risk of delayed feeding behavior in the untreated group. However, the delay in lactogenesis II may not be clinically important, since there was no statistically significant difference between the groups in the percentage of mothers experiencing feeding difficulties after day 4 postpartum.[18] A case control study compared the rate of predominant breastfeeding at 2 weeks postpartum in mothers who took an SSRI antidepressant throughout pregnancy and at delivery (n = 167) or an SSRI during pregnancy only (n = 117) to a control group of mothers who took no antidepressants (n = 182). Among the two groups who had taken an SSRI, 33 took citalopram, 18 took escitalopram, 63 took fluoxetine, 2 took Fluvoxaminum, 78 took paroxetine, and 87 took sertraline. Among the women who took an SSRI, the breastfeeding rate at 2 weeks postpartum was 27% to 33% lower than mother who did not take antidepressants, with no statistical difference in breastfeeding rates between the SSRI-exposed groups.[19] An observational study looked at outcomes of 2859 women who took an antidepressant during the 2 years prior to pregnancy. Compared to women who did not take an antidepressant during pregnancy, mothers who took an antidepressant during all 3 trimesters of pregnancy were 37% less likely to be breastfeeding upon hospital discharge. Mothers who took an antidepressant only during the third trimester were 75% less likely to be breastfeeding at discharge. Those who took an antidepressant only during the first and second trimesters did not have a reduced likelihood of breastfeeding at discharge.[20] The antidepressants used by the mothers were not specified. A retrospective cohort study of hospital electronic medical records from 2001 to 2008 compared women who had been dispensed an antidepressant during late gestation (n = 575; Fluvoxaminum n = 18) to those who had a psychiatric illness but did not receive an antidepressant (n = 1552) and mothers who did not have a psychiatric diagnosis (n = 30,535). Women who received an antidepressant were 37% less likely to be breastfeeding at discharge than women without a psychiatric diagnosis, but no less likely to be breastfeeding than untreated mothers with a psychiatric diagnosis.[21]