Last update Oct. 12, 2022

Sibutramine Hydrochloride

High Risk

Poorly safe. Evaluate carefully. Use safer alternative or interrupt breastfeeding 3 to 7 T ½ (elimination half-lives). Read the Comment.

It is a reuptake inhibitor of serotonin, norepinephrine and, to a lesser extent, dopamine, structurally related to amphetamine. It has been used in the treatment of obesity. Oral administration once daily.

On latest update relevant published data on breastfeeding were not found.

Because of high protein-binding, excretion into breast milk seems unlikely.

The more T1/2 elapsed, the less plasma concentration (and in breast milk) of the drug. Its metabolite M2 has a T1/2 of 17 hours (Abbott 2000), which would make it necessary to stop breastfeeding for 51 to 119 hours after administration.

May or may not cause increased prolactin and galactorrhea. (Soares 2011, Florakis 2008)

Because of cardiovascular side effects (Arrhythmia, Hypertension, Heart infarction) several regulatory agencies have withdrawn it from the market in many countries. (EMEA 2010, FDA 2010, MHRA 2010)

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.)
  • Naltrexone Hydrochloride ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Orlistat (Possibly safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.)

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

Sibutramine Hydrochloride in other languages or writings:

Groups

Sibutramine Hydrochloride belongs to these groups or families:

Tradenames

Main tradenames from several countries containing Sibutramine Hydrochloride in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. ≥ 77 %
Molecular weight 334 daltons
Protein Binding 94 - 97 %
Tmax 1 - 3 hours
1.1 / Metab. M1-M2: 15 - 17 hours

References

  1. 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)
  2. 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)
  3. 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
  4. 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
  5. 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)
  6. 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
  7. Soares Leaes CG, Pereira-Lima JF, da Costa Oliveira M. A case of sibutramine-induced hyperprolactinemia. Neuro Endocrinol Lett. 2011 Abstract
  8. MHRA (UK). Sibutramine: Suspension of marketing authorisation as risks outweigh benefits. Safety warnings and messages for medicines. 2010 Full text (link to original source) Full text (in our servers)
  9. FDA. FDA Recommends Against the Continued Use of Meridia (sibutramine). FDA Drug Safety Communication. 2010 Full text (link to original source) Full text (in our servers)
  10. EMEA. European Medicines Agency recommends suspension of marketing authorisations for sibutramine. Press Office. 2010 Full text (link to original source) Full text (in our servers)
  11. Florakis D, Diamanti-Kandarakis E, Katsikis I, Nassis GP, Karkanaki A, Georgopoulos N, Panidis D. Effect of hypocaloric diet plus sibutramine treatment on hormonal and metabolic features in overweight and obese women with polycystic ovary syndrome: a randomized, 24-week study. Int J Obes (Lond). 2008 Abstract Full text (link to original source) Full text (in our servers)
  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. 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)
  15. Sibutramine. Drug Summary. 2000 Full text (in our servers)
  16. Sibutramina. Ficha técnica. 2000 Full text (in our servers)
  17. Dewey KG, Heinig MJ, Nommsen LA. Maternal weight-loss patterns during prolonged lactation. Am J Clin Nutr. 1993 Aug;58(2):162-6. Abstract
  18. 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

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