Last update May 14, 2021

Fluvoxamine Maleate

Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

SSRI antidepressant with actions and uses similar to those of fluoxetine.
Oral administration once or twice daily.

It is excreted in breast milk in small amounts (Weisskopf 2017, Kristensen 2002, Arnold 2000, Hägg 2000, Yoshida 1997, Wright 1991). Serum levels of infants from breastfeeding mothers who were treated have been shown to be undetectable or very low (Kristensen 2002, Piontek 2001, Hendrick 2001) with some exception (Arnold 2000).

Although there are some isolated case of gastroenteritis (Uguz 2015), no short-term or long-term problems have been observed in the majority of infants whose mothers took it (Gentile 2006, Kristensen 2002, Hendrick 2003 y 2001, Arnold 2000, Yoshida 1997, Wright 1991).

Neonatal poor adaptation problems have not been observed during the immediate neonatal period, in term or preterm infants whose mothers took fluvoxamine during pregnancy (Kieviet 2015).

Galactorrhea associated or not to hyperprolactinemia, may appear (Chakladar 2020, Trenque 2011, Egberts 1997).

Several medical societies, experts and expert consensus, consider the use of this medication safe or probably safe during breastfeeding (Hale, Lactmed, Uguz 2021, Sriraman 2015, Orsolini 2015, Rowe 2013, Davanzo 2011, Berle 2011, Patil 2011, Lanza 2011, Gentile 2005, Rubin 2004, Gjerdingen 2003, Nordeng 2001).

Safer known alternatives may be preferable, especially during the neonatal period and in cases of prematurity (Weissman 2004).

Women suffering from depression during pregnancy need more breastfeeding support due to their increased risk of breastfeeding problems and early weaning (Grzeskowiak 2018, Leggett 2017, Venkatesh 2017, Gorman 2012).


See below the information of this related product:

  • Maternal Depression (Moderately safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.)

Alternatives

Suggestions made at e-lactancia are done by APILAM team, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Fluvoxamine Maleate in other languages or writings:

Group

Fluvoxamine Maleate belongs to this group or family:

Tradenames

Main tradenames from several countries containing Fluvoxamine Maleate in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 53 %
Molecular weight 434 daltons
Protein Binding 80 %
VD 25 l/Kg
pKa 8.9 -
Tmax 3 - 8 hours
T1/2 15.6 hours
M/P ratio 0.3 - 1.3 -
Theoretical Dose 0.04 mg/Kg/d
Relative Dose 0.3 - 1.6 %

References

  1. Uguz F. A New Safety Scoring System for the Use of Psychotropic Drugs During Lactation. Am J Ther. 2021 Jan-Feb 01;28(1):e118-e126. Abstract
  2. Chakladar A, Singh J, Tak NK, Patra BN, Sagar R. Fluvoxamine-Associated Galactorrhea: A Case Report. J Clin Psychopharmacol. 2020 Jan/Feb;40(1):101-102. Abstract
  3. Grzeskowiak LE, Leggett C, Costi L, Roberts CT, Amir LH. Impact of serotonin reuptake inhibitor use on breast milk supply in mothers of preterm infants: a retrospective cohort study. Br J Clin Pharmacol. 2018 Jun;84(6):1373-1379. Abstract
  4. Leggett C, Costi L, Morrison JL, Clifton VL, Grzeskowiak LE. Antidepressant Use in Late Gestation and Breastfeeding Rates at Discharge from Hospital. J Hum Lact. 2017 Nov;33(4):701-709. Abstract
  5. Weisskopf E, Panchaud A, Nguyen KA, Grosjean D, Hascoët JM, Csajka C, Eap CB, Ansermot N; collaborators of the SSRI-Breast Milk study.. Simultaneous determination of selective serotonin reuptake inhibitors and their main metabolites in human breast milk by liquid chromatography-electrospray mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2017 Jul 1;1057:101-109. Abstract
  6. Venkatesh KK, Castro VM, Perlis RH, Kaimal AJ. Impact of antidepressant treatment during pregnancy on obstetric outcomes among women previously treated for depression: an observational cohort study. J Perinatol. 2017 Sep;37(9):1003-1009. Abstract
  7. Orsolini L, Bellantuono C. Serotonin reuptake inhibitors and breastfeeding: a systematic review. Hum Psychopharmacol. 2015 Jan;30(1):4-20. Abstract
  8. 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 Apr;104(4):384-91. Abstract
  9. Sriraman NK, Melvin K, Meltzer-Brody S. ABM Clinical Protocol #18: Use of Antidepressants in Breastfeeding Mothers. Breastfeed Med. 2015 Abstract Full text (link to original source) Full text (in our servers)
  10. Uguz F. Gastrointestinal Side Effects in the Baby of a Breastfeeding Woman Treated with Low-Dose Fluvoxamine. J Hum Lact. 2015 Aug;31(3):371-3. Abstract
  11. Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):275-94. Abstract
  12. Abbott. Fluvoxamine. Drug Summary. 2013 Full text (in our servers)
  13. AEMPS. Fluvoxamina. Ficha técnica. 2012 Full text (in our servers)
  14. Gorman JR, Kao K, Chambers CD. Breastfeeding among women exposed to antidepressants during pregnancy. J Hum Lact. 2012 Abstract
  15. Berle JO, Spigset O. Antidepressant Use During Breastfeeding. Curr Womens Health Rev. 2011 Abstract Full text (link to original source) Full text (in our servers)
  16. Davanzo R, Copertino M, De Cunto A, Minen F, Amaddeo A. Antidepressant drugs and breastfeeding: a review of the literature. Breastfeed Med. 2011 Abstract
  17. Patil AS, Kuller JA, Rhee EH. Antidepressants in pregnancy: a review of commonly prescribed medications. Obstet Gynecol Surv. 2011 Abstract
  18. Trenque T, Herlem E, Auriche P, Dramé M. Serotonin reuptake inhibitors and hyperprolactinaemia: a case/non-case study in the French pharmacovigilance database. Drug Saf. 2011 Abstract
  19. Lanza di Scalea T, Wisner KL. Antidepressant medication use during breastfeeding. Clin Obstet Gynecol. 2009 Abstract Full text (link to original source) Full text (in our servers)
  20. Gentile S. Quetiapine-fluvoxamine combination during pregnancy and while breastfeeding. Arch Womens Ment Health. 2006 Abstract Full text (link to original source) Full text (in our servers)
  21. Gentile S. The safety of newer antidepressants in pregnancy and breastfeeding. Drug Saf. 2005 Abstract
  22. Weissman AM, Levy BT, Hartz AJ, Bentler S, Donohue M, Ellingrod VL, Wisner KL. Pooled analysis of antidepressant levels in lactating mothers, breast milk, and nursing infants. Am J Psychiatry. 2004 Abstract Full text (link to original source) Full text (in our servers)
  23. Rubin ET, Lee A, Ito S. When breastfeeding mothers need CNS-acting drugs. Can J Clin Pharmacol. 2004 Fall;11(2):e257-66. Epub 2004 Dec 8. Abstract
  24. Gjerdingen D. The effectiveness of various postpartum depression treatments and the impact of antidepressant drugs on nursing infants. J Am Board Fam Pract. 2003 Abstract Full text (link to original source) Full text (in our servers)
  25. Hendrick V, Smith LM, Hwang S, Altshuler LL, Haynes D. Weight gain in breastfed infants of mothers taking antidepressant medications. J Clin Psychiatry. 2003 Abstract
  26. Kristensen JH, Hackett LP, Kohan R, Paech M, Ilett KF. The amount of fluvoxamine in milk is unlikely to be a cause of adverse effects in breastfed infants. J Hum Lact. 2002 Abstract
  27. Hendrick V, Fukuchi A, Altshuler L, Widawski M, Wertheimer A, Brunhuber MV. Use of sertraline, paroxetine and fluvoxamine by nursing women. Br J Psychiatry. 2001 Abstract Full text (link to original source) Full text (in our servers)
  28. Piontek CM, Wisner KL, Perel JM, Peindl KS. Serum fluvoxamine levels in breastfed infants. J Clin Psychiatry. 2001 Abstract
  29. Nordeng H, Bergsholm YK, Bøhler E, Spigset O. Overgang av selektive serotoninreopptakshemmere til morsmelk \ [The transfer of selective serotonin reuptake inhibitors to human milk]. Tidsskr Nor Laegeforen. 2001 Abstract Full text (link to original source) Full text (in our servers)
  30. Arnold LM, Suckow RF, Lichtenstein PK. Fluvoxamine concentrations in breast milk and in maternal and infant sera. J Clin Psychopharmacol. 2000 Abstract
  31. Hägg S, Granberg K, Carleborg L. Excretion of fluvoxamine into breast milk. Br J Clin Pharmacol. 2000 Abstract Full text (link to original source) Full text (in our servers)
  32. Yoshida K, Smith B, Kumar RC. Fluvoxamine in breast-milk and infant development. Br J Clin Pharmacol. 1997 Abstract
  33. Egberts AC, Meyboom RH, De Koning FH, Bakker A, Leufkens HG. Non-puerperal lactation associated with antidepressant drug use. Br J Clin Pharmacol. 1997 Abstract Full text (link to original source) Full text (in our servers)
  34. Wright S, Dawling S, Ashford JJ. Excretion of fluvoxamine in breast milk. Br J Clin Pharmacol. 1991 Abstract Full text (link to original source) Full text (in our servers)

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