Last update Oct. 12, 2022

Orlistat

Low Risk

Possibly safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.

It is a gastric and pancreatic lipase inhibitor that limits the absorption of dietary fat by 30% (Guerciolini 1997). Oral administration three times a day.

At latest update, relevant information on excretion into breast milk was not found.

However, because of pharmacokinetic data (a moderately high molecular-weight, a virtually nil absorption, and very high protein-binding-capacity), excretion of Orlistat into breast milk in significant levels is unlikely.

Orlistat has virtually no intestinal absorption (Zhi 1995). Plasma (AEMPS 2014) and breast milk (Musatadi 2021) concentrations have been found at insignificant levels (<10 and <3 micrograms/L, respectively).

On long-standing basis, it may affect absorption of liposoluble vitamins (A, D, E, K), beta-carotenes and colesterol (Mittendorfer 2001, Melia 1996). This would be a reason to recommend a varied diet which should be rich in consumption of fruits, vegetables. Vitamin supplementation should also be considered. Nutritional status of the nursing mother should be monitored.

Expert authors consider the use of orlistat to be safe or very probably safe during breastfeeding. (Hale, LactMed, Briggs 2015)

There is good quality evidence that exclusive breastfeeding helps to regain pre-pregnancy weight earlier than if breastfeeding is partial (mixed) or there is no breastfeeding, and that prolonged breastfeeding helps maintain that loss and as well as body fat loss.(Jayasinghe 2021, Schalla 2017, López 2016, Jarlenski 2014, Sámano 2013, Neville 2014, Hatsu 2008, Dewey 2004, 2001 y 1993, Kramer 1993)

Alternatives

  • Hypocaloric Diet ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Liraglutide ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Maternal Sport ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Metformin Hydrochloride ( Safe. Compatible. Minimal risk for breastfeeding and infant.)

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

Orlistat in other languages or writings:

Groups

Orlistat belongs to these groups or families:

Tradenames

Main tradenames from several countries containing Orlistat in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. ≈ 0 %
Molecular weight 496 daltons
Protein Binding 99 %
Tmax 8 hours
1 - 2 hours

References

  1. Hale TW. Medications & Mothers' Milk. 1991- . Springer Publishing Company. Available from https://www.halesmeds.com Consulted on March 17, 2022 Full text (link to original source)
  2. LactMed. Drugs and Lactation Database (LactMed). Internet. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/ 2006 - Consulted on March 15, 2022 Full text (link to original source)
  3. Musatadi M, Gonzalez-Gaya B, Irazola M, Prieto A, Etxebarria n, Olivares M, Zuloaga O. Multi-target analysis and suspect screening of xenobiotics in milk by UHPLC-HRMS/MS. Separations. 2021;8,14. Abstract Full text (link to original source)
  4. Jayasinghe S, Herath MP, Beckett JM, Ahuja KDK, Byrne NM, Hills AP. Exclusivity of breastfeeding and body composition: learnings from the Baby-bod study. Int Breastfeed J. 2021 May 19;16(1):41. Abstract Full text (link to original source)
  5. Schalla SC, Witcomb GL, Haycraft E. Body Shape and Weight Loss as Motivators for Breastfeeding Initiation and Continuation. Int J Environ Res Public Health. 2017 Jul 11;14(7). pii: E754. Abstract Full text (link to original source)
  6. López-Olmedo N, Hernández-Cordero S, Neufeld LM, García-Guerra A, Mejía-Rodríguez F, Méndez Gómez-Humarán I. The Associations of Maternal Weight Change with Breastfeeding, Diet and Physical Activity During the Postpartum Period. Matern Child Health J. 2016 Feb;20(2):270-80. Abstract
  7. Briggs GG, Freeman RK, Towers CV, Forinash AB. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. Wolters Kluwer Health. Tenth edition (acces on line) 2015
  8. Neville CE, McKinley MC, Holmes VA, Spence D, Woodside JV. The relationship between breastfeeding and postpartum weight change--a systematic review and critical evaluation. Int J Obes (Lond). 2014 Apr;38(4):577-90. Abstract
  9. AEMPS. Orlistat. Ficha técnica. 2014 Full text (in our servers)
  10. Jarlenski MP, Bennett WL, Bleich SN, Barry CL, Stuart EA. Effects of breastfeeding on postpartum weight loss among U.S. women. Prev Med. 2014 Dec;69:146-50. Abstract Full text (link to original source)
  11. Sámano R, Martínez-Rojano H, Godínez Martínez E, Sánchez Jiménez B, Villeda Rodríguez GP, Pérez Zamora J, Casanueva E. Effects of breastfeeding on weight loss and recovery of pregestational weight in adolescent and adult mothers. Food Nutr Bull. 2013 Jun;34(2):123-30. Abstract
  12. Hatsu IE, McDougald DM, Anderson AK. Effect of infant feeding on maternal body composition. Int Breastfeed J. 2008 Aug 6;3:18. Abstract Full text (link to original source)
  13. Dewey KG. Impact of breastfeeding on maternal nutritional status. Adv Exp Med Biol. 2004;554:91-100. Review. Abstract
  14. Mittendorfer B, Ostlund RE Jr, Patterson BW, Klein S. Orlistat inhibits dietary cholesterol absorption. Obes Res. 2001 Abstract
  15. Dewey KG, Cohen RJ, Brown KH, Rivera LL. Effects of exclusive breastfeeding for four versus six months on maternal nutritional status and infant motor development: results of two randomized trials in Honduras. J Nutr. 2001 Feb;131(2):262-7. Abstract Full text (link to original source) Full text (in our servers)
  16. Guerciolini R. Mode of action of orlistat. Int J Obes Relat Metab Disord. 1997 Abstract
  17. Melia AT, Koss-Twardy SG, Zhi J. The effect of orlistat, an inhibitor of dietary fat absorption, on the absorption of vitamins A and E in healthy volunteers. J Clin Pharmacol. 1996 Abstract
  18. Zhi J, Melia AT, Eggers H, Joly R, Patel IH. Review of limited systemic absorption of orlistat, a lipase inhibitor, in healthy human volunteers. J Clin Pharmacol. 1995 Abstract
  19. Kramer FM, Stunkard AJ, Marshall KA, McKinney S, Liebschutz J. Breast-feeding reduces maternal lower-body fat. J Am Diet Assoc. 1993 Apr;93(4):429-33. Abstract
  20. Dewey KG, Heinig MJ, Nommsen LA. Maternal weight-loss patterns during prolonged lactation. Am J Clin Nutr. 1993 Aug;58(2):162-6. Abstract

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