Last update June 18, 2022

N06AX16

Compatible

Safe substance and/or breastfeeding is the best option.

It is a reuptake-inhibitor of Serotonin and Norepinephrine, and a precursor of Desvenlafaxine. Oral administration one to three times a day. 

It is excreted into breast milk in small to moderate amount that may be clinically significant (Pogliani 2019, Schoretsanitis 2018, Rampono 2011, Newport 2009, Misri 2006, Koren 2006, Berle 2004, Ilett 2002), which can reach 10% of the relative dose. (Newport 2009, Ilett 1998) 

Plasma levels in infants whose mothers take it are undetectable to low (Rampono 211, Newport 2009, Berle 2004, Weissman 2004, Hendrick 2001, Ilett 2002 and 1998), sometimes between 10% (Berle 2004) and 37% (Newport 2009) of maternal levels.

However, side-effects in those infants have not been shown. Various studies failed to show short or long-term side-effects among infants whose mothers were on Venlafaxine, both on physical or psychomotor development. (Pogliani 2019, Rampono 2011, Newport 2009, Misri 2006, Berle 2004, Hendrick 2003 y 2001, Ilett 2002 y 1998)

It may induce galactorrhea and elevated prolactin levels. (Camkurt 2017, Ashton 2007, Pae 2004)

The poor extrauterine adaptation that may appear in neonates just after birth when the pregnant woman has been treated with selective reuptake-inhibitors of Serotonin like Venlafaxine or Mirtazapine (Hale 2010), is seen to be mild if the baby is breastfed (Kieviet 2013, Lanza 2009). Two newborns whose mothers were taking venlafaxine 300 and 375 mg daily during pregnancy experienced withdrawal symptoms in the first few days that improved when breastfeeding was instituted. (Boucher 2009, Koren 2006)

Various medical societies and expert consensus consider the use of this medication safe during breastfeeding. (Hale, Sriraman 2015, Rowe 2013, Berle 2011, Patil 2011, Schaefer 2007, Gjerdingen 2003).


See below the information of these related products:

  • Desvenlafaxine Succinate (Safe substance and/or breastfeeding is the best option.)
  • Maternal Depression (Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.)

Alternatives

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

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

N06AX16 is Venlafaxine Hydrochloride in ATC Code/s.

Is written in other languages:

N06AX16 is also known as

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 40 - 45 %
Molecular weight 314 daltons
Protein Binding 27 - 30 %
VD 5.7 - 7.5 l/Kg
pKa 9.4 -
Tmax 3 (Met ODV: 6 - 8.8) hours
5 (Met ODV: 11) hours
M/P ratio 1.3 - 6 -
Theoretical Dose 0.02 - 0.38 mg/Kg/d
Relative Dose 5.5 ( 2.7 - 10.1 ) %

References

  1. Hale TW. Medications & Mothers' Milk. 1991- . Springer Publishing Company. Available from https://www.halesmeds.com Consulted on April 10, 2024 Full text (link to original source)
  2. 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
  3. AEMPS - Normon Venlafaxina. Ficha técnica. 2019 Full text (in our servers)
  4. Schoretsanitis G, Augustin M, Saßmannshausen H, Franz C, Gründer G, Paulzen M. Antidepressants in breast milk; comparative analysis of excretion ratios. Arch Womens Ment Health. 2019 Jun;22(3):383-390. Abstract
  5. Pogliani L, Baldelli S, Cattaneo D, Pileri P, Clementi E, Cetin I, Zuccotti G. Selective serotonin reuptake inhibitors' passage into human milk of lactating women. J Matern Fetal Neonatal Med. 2019 Sep;32(18):3020-3025. Abstract
  6. Camkurt MA, Gülpamuk G, Fındiklı E, Elve R. Dose Dependent Course of Hyperprolactinemic and Normoprolactinemic Galactorrhea Induced by Venlafaxine. Clin Psychopharmacol Neurosci. 2017 May 31;15(2):181-183. Abstract
  7. Tran MM, Fancourt N, Ging JM, Tantsis EM, Nelson TY, Sharma R. Failure to thrive potentially secondary to maternal venlafaxine use. Australas Psychiatry. 2016 Feb;24(1):98-9. Abstract
  8. 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)
  9. Apotex. Venlafaxine. Drug Summary. 2014 Full text (in our servers)
  10. Sachs HC; Committee On Drugs. The transfer of drugs and therapeutics into human breast milk: an update on selected topics. Pediatrics. 2013 Sep;132(3):e796-809. Abstract Full text (link to original source) Full text (in our servers)
  11. Kieviet N, Dolman KM, Honig A. The use of psychotropic medication during pregnancy: how about the newborn? Neuropsychiatr Dis Treat. 2013 Abstract Full text (link to original source) Full text (in our servers)
  12. Rowe H, Baker T, Hale TW. Maternal medication, drug use, and breastfeeding. Pediatr Clin North Am. 2013 Feb;60(1):275-94. Abstract
  13. 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)
  14. Rampono J, Teoh S, Hackett LP, Kohan R, Ilett KF. Estimation of desvenlafaxine transfer into milk and infant exposure during its use in lactating women with postnatal depression. Arch Womens Ment Health. 2011 Abstract
  15. Patil AS, Kuller JA, Rhee EH. Antidepressants in pregnancy: a review of commonly prescribed medications. Obstet Gynecol Surv. 2011 Abstract
  16. Hale TW, Kendall-Tackett K, Cong Z, Votta R, McCurdy F. Discontinuation syndrome in newborns whose mothers took antidepressants while pregnant or breastfeeding. Breastfeed Med. 2010 Abstract
  17. 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)
  18. Boucher N, Koren G, Beaulac-Baillargeon L. Maternal use of venlafaxine near term: correlation between neonatal effects and plasma concentrations. Ther Drug Monit. 2009 Jun;31(3):404-9. Abstract
  19. AEMPS. Venlafaxina. Ficha técnica. 2008 Full text (in our servers)
  20. Ashton AK, Longdon MC. Hyperprolactinemia and galactorrhea induced by serotonin and norepinephrine reuptake inhibiting antidepressants. Am J Psychiatry. 2007 Abstract
  21. Schaefer C, Peters P, Miller RK. Drugs During Pregnancy and Lactation. Treatment options and risk assessment. Elsevier, second edition. London. 2007
  22. Misri S, Corral M, Wardrop AA, Kendrick K. Quetiapine augmentation in lactation: a series of case reports. J Clin Psychopharmacol. 2006 Oct;26(5):508-11. Abstract
  23. Koren G, Moretti M, Kapur B. Can venlafaxine in breast milk attenuate the norepinephrine and serotonin reuptake neonatal withdrawal syndrome. J Obstet Gynaecol Can. 2006 Abstract
  24. Gentile S. The safety of newer antidepressants in pregnancy and breastfeeding. Drug Saf. 2005 Abstract
  25. 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)
  26. Pae CU, Kim JJ, Lee CU, Chae JH, Lee SJ, Lee C, Paik IH. Very low dose quetiapine-induced galactorrhea in combination with venlafaxine. Hum Psychopharmacol. 2004 Aug;19(6):433-4. No abstract available. Abstract
  27. Berle JØ, Steen VM, Aamo TO, Breilid H, Zahlsen K, Spigset O. Breastfeeding during maternal antidepressant treatment with serotonin reuptake inhibitors: infant exposure, clinical symptoms, and cytochrome p450 genotypes. J Clin Psychiatry. 2004 Abstract
  28. 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
  29. 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)
  30. Ilett KF, Kristensen JH, Hackett LP, Paech M, Kohan R, Rampono J. Distribution of venlafaxine and its O-desmethyl metabolite in human milk and their effects in breastfed infants. Br J Clin Pharmacol. 2002 Abstract
  31. Hendrick V, Altshuler L, Wertheimer A, Dunn WA. Venlafaxine and breast-feeding. Am J Psychiatry. 2001 Abstract
  32. Ilett KF, Hackett LP, Dusci LJ, Roberts MJ, Kristensen JH, Paech M, Groves A, Yapp P. Distribution and excretion of venlafaxine and O-desmethylvenlafaxine in human milk. Br J Clin Pharmacol. 1998 Abstract

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