Question

I am a breastfeeding mother and i want to know if it is safe to use MDL 16455? Is MDL 16455 safe for nursing mother and child? Does MDL 16455 extracts into breast milk? Does MDL 16455 has any long term or short term side effects on infants? Can MDL 16455 influence milk supply or can MDL 16455 decrease milk supply in lactating mothers?

MDL 16455 lactation summary

MDL 16455 is safe in breastfeeding
  • DrLact safety Score for MDL 16455 is 1 out of 8 which is considered Safe as per our analyses.
  • A safety Score of 1 indicates that usage of MDL 16455 is mostly safe during lactation for breastfed baby.
  • Our study of different scientific research also indicates that MDL 16455 does not cause any serious side effects in breastfeeding mothers.
  • Most of scientific studies and research papers declaring usage of MDL 16455 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 MDL 16455 usage in lactation

Antihistamine drug of 2nd generation, piperidine derivative, which is an active metabolite of Terfenadine with minimal sedative effect. Oral administration twice a day. It is excreted into breast milk in clinically non-significant amount (Butler 2014, So 2010, Leachman 2006, Lucas 1995). On a telephone interview, 10% of infants whose mothers were on terfenadine, recognized to have experienced colicky pain and hyperexcitability that disappeared without treatment (Ito 1993). American Academy of Pediatrics: medication usually compatible with breastfeeding (AAP 2001).

Answer by DrLact: About MDL 16455 usage in lactation

Because of its lack of sedation and low milk levels, maternal use of MDL 16455 would not be expected to cause any adverse effects in breastfed infants. MDL 16455 might have a negative effect on lactation, especially in combination with a sympathomimetic agent such as pseudoephedrine.

MDL 16455 Side Effects in Breastfeeding

In one telephone follow-up study of 25 infants exposed to the MDL 16455's parent drug terfenadine, 3 mothers reported irritability in their infants. None of the reactions required medical attention.[2]

MDL 16455 Possible Effects in Breastfeeding

Antihistamines in relatively high doses given by injection can decrease basal serum prolactin in nonlactating women and in early postpartum women.[3][4] However, suckling-induced prolactin secretion is not affected by antihistamine pretreatment of postpartum mothers.[3] Whether lower oral doses of antihistamines have the same effect on serum prolactin or whether the effects on prolactin have any consequences on breastfeeding success have not been studied. 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.