Last update Jan. 13, 2022

Varenicline

Limited compatibility

Unsafe. Moderate/severe adverse effects. Compatible under certain circumstances. Follow-up recommended. Use safer alternative or discontinue breastfeeding from 5 to 7 T ½ . Read Commentary.

It is a nicotine receptor agonist, which is specifically used for quitting from the tobacco smoking habit (Pfizer 2019, Baraona 2017, EMA 2016). Oral administration in two daily doses.

Since the last update we have not found any published data on its excretion in breast milk.

Its pharmacokinetic data (low molecular weight, low protein binding and prolonged half-life) makes transfer to milk possible in amounts that could be significant, although its wide volume of distribution would make it difficult.

Until more published data is known about this drug in relation to breastfeeding, known safer alternatives are preferable (Phillips 2021, Le Lous 2020, Baraona 2017, Underner 2017, Carson 2013, Sachs 2013, Einarson 2009), especially during the neonatal period and in the event of prematurity.

 

Alternatives

  • Bupropion-Hcl (Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.)
  • Nicotine Replacement Therapy (NRT) (Safe product and/or breastfeeding is the best option.)

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

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Other names

Varenicline in other languages or writings:

Group

Varenicline belongs to this group or family:

Tradenames

Main tradenames from several countries containing Varenicline in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 99 %
Molecular weight 211 daltons
Protein Binding 20 %
VD 4.8 - 5.9 l/Kg
Tmax 3 - 4 hours
T½ 24 - 33 hours

References

  1. Phillips L, Campbell KA, Coleman T, Ussher M, Cooper S, Lewis S, Orton S. Barriers and Facilitators to Staying Smoke-Free after Having a Baby, a Qualitative Study: Women's Views on Support Needed to Prevent Returning to Smoking Postpartum. Int J Environ Res Public Health. 2021 Oct 28;18(21). pii: 11358. Abstract
  2. Le Lous M, Torchin H. [Smoking and Breastfeeding - CNGOF-SFT Expert Report and Guidelines on the management for Smoking Management During Pregnancy]. Gynecol Obstet Fertil Senol. 2020 Jul - Aug;48(7-8):612-618. Abstract
  3. Baraona LK, Lovelace D, Daniels JL, McDaniel L. Tobacco Harms, Nicotine Pharmacology, and Pharmacologic Tobacco Cessation Interventions for Women. J Midwifery Womens Health. 2017 Abstract
  4. Underner M, Pourrat O, Perriot J, Peiffer G, Jaafari N. [Smoking cessation and pregnancy]. Gynecol Obstet Fertil Senol. 2017 Oct;45(10):552-557. Abstract
  5. Carson KV, Brinn MP, Robertson TA, To-A-Nan R, Esterman AJ, Peters M, Smith BJ. Current and emerging pharmacotherapeutic options for smoking cessation. Subst Abuse. 2013 Abstract Full text (link to original source) Full text (in our servers)
  6. 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)
  7. Einarson A, Riordan S. Smoking in pregnancy and lactation: a review of risks and cessation strategies. Eur J Clin Pharmacol. 2009 Abstract

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