Question

I am a breastfeeding mother and i want to know if it is safe to use Ro 1-5130? Is Ro 1-5130 safe for nursing mother and child? Does Ro 1-5130 extracts into breast milk? Does Ro 1-5130 has any long term or short term side effects on infants? Can Ro 1-5130 influence milk supply or can Ro 1-5130 decrease milk supply in lactating mothers?

Ro 1-5130 lactation summary

Ro 1-5130 is safe in breastfeeding
  • DrLact safety Score for Ro 1-5130 is 1 out of 8 which is considered Safe as per our analyses.
  • A safety Score of 1 indicates that usage of Ro 1-5130 is mostly safe during lactation for breastfed baby.
  • Our study of different scientific research also indicates that Ro 1-5130 does not cause any serious side effects in breastfeeding mothers.
  • Most of scientific studies and research papers declaring usage of Ro 1-5130 safe in breastfeeding are based on normal dosage and may not hold true for higher 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 Ro 1-5130 usage in lactation

Reversible cholinesterase inhibitor used for treatment of Myasthenia Gravis (see specific info). It is excreted into breast milk at undetectable levels (Skoglund 1978) or clinically non-significant (Hardell 1982, Djelmis 2002) without harmful effects having been observed in infants whose mothers were treated (Skoglund 1978, Hardell 1982). Plasma levels in such infants were undetectable (Hardell 1982). Because of a low oral bioavailability it seems even more unlikely the pass to the infant’s plasma through ingested breastmilk, except in preterm infants and immediate neonatal period, when there may be an increased intestinal permeability. American Academy of Pediatrics: medication usually compatible with breastfeeding.WHO 2002 List of Essential Medicines: compatible with breastfeeding.

Answer by DrLact: About Ro 1-5130 usage in lactation

Because of the low levels of Ro 1-5130 in breastmilk, amounts ingested by the infant are small and infant serum levels are very low. Ro 1-5130 is not be expected to cause any adverse effects in breastfed infants. Most mothers with myasthenia gravis are able to nurse successfully with Ro 1-5130 treatment, but occasionally breastfeeding must be discontinued to avoid excessive fatigue in the mother.

Ro 1-5130 Side Effects in Breastfeeding

A woman was taking Ro 1-5130 120 mg every 4 to 5 hours for myasthenia gravis. Her breastfed (extent not stated) infant reportedly thrived and had no cholinergic side effects.[1] Two infants whose mothers were taking Ro 1-5130 3 and 5 mg/kg daily during pregnancy and lactation were exclusively breastfed. Both infants gained weight and developed normally and had no signs of cholinergic side effects.[2]

Ro 1-5130 Possible Effects in Breastfeeding

Relevant published information in nursing mothers was not found as of the revision date. In animals, cholinergic drugs increase oxytocin release,[3] and have variable effects on serum prolactin.[4] The prolactin level in a mother with established lactation may not affect her ability to breastfeed. In a case series of 69 pregnancies in 65 women with myasthenia gravis over 27 years, 49 patients received Ro 1-5130 during pregnancy and lactation. Lactation data were available for 33 patients, and 25 of them nursed successfully, although the number of these mothers who were taking Ro 1-5130 was not given. Nursing was sometimes disrupted to avoid exhaustion in the mother.[5]
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