Question

I am a breastfeeding mother and i want to know if it is safe to use HSDB 5716? Is HSDB 5716 safe for nursing mother and child? Does HSDB 5716 extracts into breast milk? Does HSDB 5716 has any long term or short term side effects on infants? Can HSDB 5716 influence milk supply or can HSDB 5716 decrease milk supply in lactating mothers?

HSDB 5716 lactation summary

HSDB 5716 is safe in breastfeeding
  • DrLact safety Score for HSDB 5716 is 1 out of 8 which is considered Safe as per our analyses.
  • A safety Score of 1 indicates that usage of HSDB 5716 is mostly safe during lactation for breastfed baby.
  • Our study of different scientific research also indicates that HSDB 5716 does not cause any serious side effects in breastfeeding mothers.
  • Most of scientific studies and research papers declaring usage of HSDB 5716 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 HSDB 5716 usage in lactation

Risperidone and its metabolite (HSDB 5716) are excreted into breast milk in non-significant amount. Untoward effect has not been observed on breastfed infants of treated mothers. Serum levels were very low or undetectable in these infants. May be a cause of galactorrhea. Thera are two types of HSDB 5716: oral and intramuscular (Depo). Depo type (HSDB 5716 Palmitate) requires intramuscular administration with a Time to Max of 13 days and a Half-time of 25 to 50 days. That would be a reason to use during breastfeeding a non-depot (oral) medication like Risperidone or any suggested alternative, as a safer choice.

Answer by DrLact: About HSDB 5716 usage in lactation

Although no data are available for the use of HSDB 5716 during breastfeeding, it is the active metabolite of risperidone. Risperidone data indicate that the concentrations of HSDB 5716 (9-hydroxyrisperidone) in breastmilk are low, and amounts ingested by the infant are small. Because there is no published experience with HSDB 5716 during breastfeeding and little long-term follow-up data, other agents may be preferred, especially while nursing a newborn or preterm infant. Because HSDB 5716 is available only as a sustained-release product, timing of nursing with respect to doses would not be useful.

HSDB 5716 Side Effects in Breastfeeding

No published information on HSDB 5716 was found as of the revision date. However, limited data from the use of its parent drug, risperidone, during nursing indicate no short- or long-term adverse effects on the infant.[3][4][5]

HSDB 5716 Possible Effects in Breastfeeding

HSDB 5716 has caused elevated prolactin serum levels, gynecomastia, and galactorrhea in patients taking the drug.[6][7][8][9][10][11] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.
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.