Last update Oct. 12, 2022

Benfluorex Hydrochloride

Incompatible

Very unsafe. Contraindicated. Use of an alternative or cessation of breastfeeding. Read the Commentary.

It is an anorectic and hypolipidemic agent structurally related to fenfluramine. Oral administration three times a day.

Since the last update we have not found published data on its excretion in breastmilk.

Due to frequent and serious cardiovascular side effects (Laurent 2022, McGee 2018, Eugène 2018, Melloul 2015, Fournier 2012), the European Medicines Agency recommended withdrawing benfluorex in 2009. (EMA 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 substance and/or breastfeeding is the best option.)
  • Liraglutide (Safe substance and/or breastfeeding is the best option.)
  • Maternal Sport (Safe substance and/or breastfeeding is the best option.)
  • Metformin Hydrochloride (Safe substance and/or breastfeeding is the best option.)
  • Naltrexone Hydrochloride (Safe substance and/or breastfeeding is the best option.)
  • Orlistat (Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.)

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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José María Paricio, founder of e-lactancia.
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Other names

Benfluorex Hydrochloride in other languages or writings:

Groups

Benfluorex Hydrochloride belongs to these groups or families:

Tradenames

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

Pharmacokinetics

Variable Value Unit
Molecular weight 351 daltons
Tmax 2 hours

References

  1. Laurent M, Ennezat PV, Malergue MC, Bruneval P; Members of the Benfluorex Committee for the Office National d’Indemnisation des Accidents Médicaux (ONIAM).. Cardiac valvular surgery and history of anorectic drug intake: A retrospective study of a large population of benfluorex-exposed patients. Arch Cardiovasc Dis. 2022 Jun-Jul;115(6-7):348-358. Consulted on Oct. 12, 2022 Abstract
  2. 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)
  3. Eugène M, Bruneval P, Bonnet N, Attias D. Benfluorex-induced severe primary tricuspid and mitral regurgitation requiring a double-valve replacement. Eur J Cardiothorac Surg. 2018 Jul 1;54(1):195. Abstract
  4. McGee M, Whitehead N, Martin J, Collins N. Drug-associated pulmonary arterial hypertension. Clin Toxicol (Phila). 2018 Sep;56(9):801-809. Abstract
  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. Melloul E, Bruneval P, Chavanon O, Lantuejoul S, Augier C, Salvat M, Maréchaux S, Tribouilloy C, Assoun B, Ennezat PV. Benfluorex: An active toxin for the development of aortic valve stenosis. Int J Cardiol. 2015 Feb 15;181:328-30. Abstract
  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. 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)
  10. 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
  11. Fournier A, Zureik M. Estimate of deaths due to valvular insufficiency attributable to the use of benfluorex in France. Pharmacoepidemiol Drug Saf. 2012 Apr;21(4):343-51. Abstract
  12. EMA. Preguntas y respuestas sobre la retirada de los medicamentos que contienen benfluorex. None 2010 Full text (link to original source) Full text (in our servers)
  13. EMA. Questions and answers on the withdrawal of medicines containing benfluorex. None 2010 Full text (link to original source) Full text (in our servers)
  14. 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)
  15. Dewey KG. Impact of breastfeeding on maternal nutritional status. Adv Exp Med Biol. 2004;554:91-100. Review. Abstract
  16. 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)
  17. Stabin MG, Breitz HB. Breast milk excretion of radiopharmaceuticals: mechanisms, findings, and radiation dosimetry. J Nucl Med. 2000 Abstract Full text (link to original source) Full text (in our servers)
  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
  19. 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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