Question

I am a breastfeeding mother and i want to know if it is safe to use BG 00012? Is BG 00012 safe for nursing mother and child? Does BG 00012 extracts into breast milk? Does BG 00012 has any long term or short term side effects on infants? Can BG 00012 influence milk supply or can BG 00012 decrease milk supply in lactating mothers?

BG 00012 lactation summary

BG 00012 usage has low risk in breastfeeding
  • DrLact safety Score for BG 00012 is 3 out of 8 which is considered Low Risk as per our analyses.
  • A safety Score of 3 indicates that usage of BG 00012 may cause some minor side effects in breastfed baby.
  • Our study of different scientific research indicates that BG 00012 may cause moderate to no side effects in lactating mother.
  • Most of scientific studies and research papers declaring usage of BG 00012 low risk in breastfeeding are based on normal dosage and may not hold true for higher dosage.
  • While using BG 00012 We suggest monitoring child for possible reactions. It is also important to understand that side effects vary largely based on age of breastfed child and time of medication in addition to dosage.
  • Score calculated using the DrLact safety Version 1.2 model, this score ranges from 0 to 8 and measures overall safety of drug in lactation. Scores are primarily calculated using publicly available case studies, research papers, other scientific journals and publically available data.

Answer by Dr. Ru: About BG 00012 usage in lactation

Anti-inflammatory and immunomodulator used in the treatment of psoriasis and in relapsing forms of multiple sclerosis. Since the last update we have not found published data on its excretion in breast milk. Its pharmacokinetic data (large volume of distribution and short half-life) make it unlikely that milk would pass through in significant quantities (Almas 2016).Possible side effects are rare and generally not serious, with no immunosuppressive effects or higher frequency of infections (EMA 2017, AEMPS 2015). Until there is more published data on this drug in relation to breastfeeding, known safer alternatives may be preferable, especially during the neonatal period and in case of prematurity (Brown 2017, Yiu 2015, Bove 2014, Cree 2013).

Answer by DrLact: About BG 00012 usage in lactation

There is no published experience with BG 00012 during breastfeeding. Although some authors recommend avoiding breastfeeding during BG 00012 therapy,[1][2] others and the manufacturer do not.[3] Avoiding breastfeeding for 4 to 5 hours after a dose should minimize infant exposure. The infant should be monitored for adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants. Some authors also recommend monitoring for vomiting and diarrhea.[3]
Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. We do not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.