Is Bromazepam compatible with breastfeeding? Do we have alternatives for Bromazepam?

Bromazepam

August 1, 2018 (High Risk)

Long-acting type benzodiazepine with properties similar to those of diazepam.
Indicated in anxiety and insomnia disorder.
Oral administration two to three times a day.

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

Their pharmacokinetic data (low molecular weight, not high protein binding, prolonged elimination time and being very lipophilic) make it likely that it would pass into breast milk in amounts which could be significant.

There is a case described coinciding with sudden death of a 23-day-old infant with risk factors, without being able to ensure causality (Anderson 2003 --> Martens 1994).

Bromazepam does not alter prolactin levels (D'Armiento 1981).

Eventual usage and at low dose of benzodiazepines is compatible with breastfeeding. Choose benzodiazepines of short duration and use the minimum effective dose, especially in the neonatal period.

Somnolence and adequate feeding of the infant should be monitored.
Co-sleeping (Bed-sharing) with the baby is not recommended if this drug is being taken (UNICEF 2013, Landa 2012, ABM 2008, UNICEF 2006).

Alternatives

Very Low Risk

Compatible. Not risky for breastfeeding or infant.

Low Risk

Moderately safe. Mild risk possible. Follow up recommended. Read the Comment.

High Risk

Poorly safe. Evaluate carefully. Use a safer alternative. Read the Comment.

Very High Risk

Not recommended. Cessation of breastfeeding or alternative.

Writings

  • Βρωμαζεπάμη (Greek)
  • برومازيبام (Arabic)
  • Бромазепам (Cyrillic)
  • 溴西泮 (Chinese)
  • ブロマゼパム (Japanese)
  • C14 H10 BrN3 O (Molecular formula)
  • 7-Bromo-1,3-dihydro-5-(2-pyridyl)-1,4-benzodiazepin-2-one (Chemical name)
  • N05BA08 (ATC Code/s)

Drug trade names

References

  1. AEMPS - Stada. Bromazepam. Ficha técnica. 2016 Full text (in our servers)
  2. UNICEF UK Baby Friendly Initiative statement on Bed-sharing when parents do not smoke: is there a risk of SIDS? An individual level analysis of five major case-control studies. 2013 Full text (link to original source) Full text (in our servers)
  3. Roche. Bromazepam (Lexotan). Drug Summary. 2012 Full text (in our servers)
  4. L.Landa Rivera, M.Díaz-Gómez, A.Gómez Papi, J.M.Paricio Talayero, C.Pallás Alonso, M.T.Hernández Aguilar, J.Aguayo Maldonado, J.M.Arena Ansotegui, S.Ares Segura, A.Jiménez Moya, J.J.Lasarte Velillas, J.Martín Calama, M.D.Romero Escós. El colecho favorece la práctica de la lactancia materna y no aumenta el riesgo de muerte súbita del lactante. Dormir con los padres. Rev Pediatr Aten Primaria. 14:53-60 2012 Full text (link to original source) Full text (in our servers)
  5. ABM - Comité de protocolos de la Academia médica de lactancia materna (Academy of Breastfeeding Medicine). Protocolo Clínico de la ABM #6: Lineamientos sobre la práctica de dormir al bebé junto con la madre y la lactancia materna Revisión, marzo de 2008. Breastfeeding Medicine 2008 Full text (link to original source) Full text (in our servers)
  6. ABM - The Academy of Breastfeeding Medicine Protocol Committee. ABM Clinical Protocol #6: Guideline on Co-Sleeping and Breastfeeding. Breastfeeding Medicine 2008Abstract Full text (link to original source) Full text (in our servers)
  7. UNICEF UK. Compartiendo la cama con tu bebé. Guía para madres que amamantan. Folleto 2006 Full text (in our servers)
  8. Anderson PO, Pochop SL, Manoguerra AS. Adverse drug reactions in breastfed infants: less than imagined. Clin Pediatr (Phila). 2003Abstract
  9. Martens PR. A sudden infant death like syndrome possibly induced by a benzodiazepine in breast-feeding. Eur J Emerg Med. 1994Abstract
  10. D'Armiento M, Bisignani G, Reda G. Effect of bromazepam on growth hormone and prolactin secretion in normal subjects. Horm Res. 1981Abstract