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Fluvoxamine use while Breastfeeding

Drugs containing Fluvoxamine: Luvox, Luvox CR

Fluvoxamine Levels and Effects while Breastfeeding

Summary of Use during Lactation

Limited information indicates that maternal fluvoxamine 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 fluvoxamine, but most who have been tested have undetectable serum levels. No adverse effects on breastfed infants have been reported, including a limited amount of long-term follow-up on growth and development. Mothers taking an SSRI during pregnancy and postpartum may have more difficulty breastfeeding and 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.

Drug Levels

Maternal Levels. In a pooled analysis of serum levels from published studies and 1 unpublished case, the authors found that 6 mothers taking an average daily dosage of 159 mg (range 50 to 300 mg) had an average milk fluvoxamine level of 174 mcg/L (range 18 to 478 mcg/L).[1] Using the average dosage and milk level data from this paper, an exclusively breastfed infant would receive an estimated 0.98% of the maternal weight-adjusted dosage of fluvoxamine.

Two mothers breastfeeding while taking stable doses of fluvoxamine were studied with timed blood and milk samples over 24 hours. The first patient, who was taking 150 mg daily and nursing a 26-month-old, had a peak milk level of 425 mcg/L at 2.1 hours after the dose. The second patient, who was taking 50 mg daily and nursing a 3-week-old, had a peak milk level of 67 mcg/L at 4.2 hours after the dose. The authors estimated the absolute infant dosages to be 38.4 and 5.4 mcg/kg daily in the two infants, respectively, or an average 1.38% and 0.8% of the maternal weight-adjusted dosage.[2]

Infant Levels. Four exclusively breastfed infants aged 6 to 13 weeks had undetectable (<1 mcg/L) fluvoxamine serum levels during maternal therapy with fluvoxamine in dosages of 100 to 150 mg daily.[3]

In a pooled analysis of 3 mother-infant pairs from published and unpublished cases, the authors found that breastfed infants had an average of 16% (range 0 to 45%) of their mothers' fluvoxamine plasma levels; 1 of the 3 infants had a plasma level greater than 10% of the mother's which was defined by the authors as being elevated.[1]

Serum levels of fluvoxamine were undetectable (<2 mcg/L) in a partially breastfed 26-month-old during maternal intake of 150 mg daily. Fluvoxamine was also undetectable in the serum of an exclusively breastfed 3-week-old during maternal intake of 50 mg daily.[2]

Effects in Breastfed Infants

One infant whose mother began taking fluvoxamine 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.[5]

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.[2]

Three mothers who took an average fluvoxamine 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.[6]

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 fluvoxamine. No specific information on maternal fluvoxamine dosage, extent of breastfeeding or infant age was reported.[7]

A woman who was treated chronically with quetiapine 400 mg and fluvoxamine 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.[8]

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 fluvoxamine in utero and none had PNA.[9]

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 fluvoxamine 50 mg daily. Symptoms resolved within 24 hours after the mother discontinued the drug, and recurred a week later after fluvoxamine was restarted in the mother. Other causes of the gastrointestinal symptoms could not be found. Fluvoxamine 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.[10]

Effects on Lactation and Breastmilk

Fluvoxamine has caused increased prolactin levels and galactorrhea in nonpregnant, nonnursing patients.[11][12][13] In one case, euprolactinemic gynecomastia and galactorrhea occurred in a 19-year-old man who was also taking risperidone.[14] In a study of cases of hyperprolactinemia and its symptoms (e.g., gynecomastia) reported to a French pharmacovigilance center, fluvoxamine was found to have a 4.5-fold increased risk of causing hyperprolactinemia compared to other drugs.[15] 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.[16]

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 fluvoxamine, 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.[17]

Alternate Drugs to Consider

Clomipramine, Nortriptyline, Paroxetine, Sertraline

References

1. Weissman AM, Levy BT, Hartz AJ et al. Pooled analysis of antidepressant levels in lactating mothers, breast milk, and nursing infants. Am J Psychiatry. 2004;161:1066-78. PMID: 15169695

2. Kristensen JH, Hackett LP, Kohan R et al. The amount of fluvoxamine in milk is unlikely to be a cause of adverse effects in breastfed infants. J Hum Lact. 2002;18:139-43. PMID: 12033075

3. Hendrick V, Fukuchi A, Altshuler L et al. Use of sertraline, paroxetine and fluvoxamine by nursing women. Br J Psychiatry. 2001;179:163-6. PMID: 11483479

4. Arnold LM, Suckow RF, Lichtenstein PK. Fluvoxamine concentrations in breast milk and in maternal and infant sera. J Clin Psychopharmacol. 2000;20:491-2. Letter. PMID: 10917415

5. Yoshida K, Smith B, Kumar RC. Fluvoxamine in breast-milk and infant development. Br J Clin Pharmacol. 1997;44:210-1. PMID: 9278215

6. Hendrick V, Smith LM, Hwang S et al. Weight gain in breastfed infants of mothers taking antidepressant medications. J Clin Psychiatry. 2003;64:410-2. PMID: 12716242

7. Lee A, Woo J, Ito S. Frequency of infant adverse events that are associated with citalopram use during breast-feeding. Am J Obstet Gynecol. 2004;190:218-21. PMID: 14749663

8. Gentile S. Quetiapine-fluvoxamine combination during pregnancy and while breastfeeding. Arch Womens Ment Health. 2006. PMID: 16633783

9. Kieviet N, Hoppenbrouwers C, Dolman KM, Berkhof J, Wennink H, Honig A. Risk factors for poor neonatal adaptation after exposure to antidepressants in utero. Acta Paediatr. 2015;104:384-91. PMID: 25559357

10. Uguz F. Gastrointestinal side effects in the baby of a breastfeeding woman treated with low-dose fluvoxamine. J Hum Lact. 2015. PMID: 25896469

11. Bonin B, Vandel P, Vandel S. Fluvoxamine and galactorrhea. A case report. Therapie. 1994;49:149-51. PMID: 7817347

12. Egberts ACG, Meyboom RHB, De Koning FHP et al. Non-puerperal lactation associated with antidepressant drug use. Br J Clin Pharmacol. 1997;44:277-81. PMID: 9296322

13. Jeffries J, Bezchlibnyk-Butler K, Remington G. Amenorrhea and galactorrhea associated with fluvoxamine in a loxapine-treated patient. J Clin Psychopharmacol. 1992;12:296-7. PMID: 1527236

14. Pratheesh PJ, Praharaj SK, Srivastava A. Euprolactinemic gynecomastia and galactorrhea with risperidone-fluvoxamine combination. Psychopharmacol Bull. 2011;44:70-3. PMID: 22506441

15. Trenque T, Herlem E, Auriche P, Drame M. Serotonin reuptake inhibitors and hyperprolactinaemia: a case/non-case study in the French pharmacovigilance database. Drug Saf. 2011;34:1161-6. PMID: 22077504

16. Marshall AM, Nommsen-Rivers LA, Hernandez LL et al. Serotonin transport and metabolism in the mammary gland modulates secretory activation and involution. J Clin Endocrinol Metab. 2010;95:837-46. PMID: 19965920

17. Gorman JR, Kao K, Chambers CD. Breastfeeding among women exposed to antidepressants during pregnancy. J Hum Lact. 2012;28:181-8. PMID: 22344850

Fluvoxamine Identification

Substance Name

Fluvoxamine

CAS Registry Number

54739-18-3

Drug Class

Antidepressants

Serotonin Uptake Inhibitors

Administrative Information

LactMed Record Number

324

Last Revision Date

20150505

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