Clopidogrel transfer into human milk: case series - a contribution from the ConcePTION project

Area of Science:

• Pharmacology
• Neonatal Medicine
• Drug Safety

Background:

• Breastfeeding recommendations are often limited by a lack of data on medication safety.
• Clopidogrel (CLP) is used for secondary prevention after cerebrovascular events.

Purpose of the Study:

• To assess the clinical and pharmacokinetic data of clopidogrel (CLP) transfer into human milk.
• To evaluate infant exposure to CLP and its metabolites during breastfeeding.

Main Methods:

• Two breastfeeding mothers treated with 75 mg clopidogrel (CLP) daily provided milk and blood samples.
• Liquid chromatography with tandem mass spectrometry was used to analyze CLP, clopidogrel carboxylic acid (CCA), and clopidogrel active metabolite (CAM) concentrations.

Main Results:

• Average steady-state concentrations in milk were 0.96 ng/mL for CLP and 7.40 ng/mL for CCA.
• Clopidogrel active metabolite (CAM) was mostly undetectable in milk; infant plasma showed detectable CCA but undetectable CLP and CAM.
• Estimated infant daily dosage (DID) and relative infant dose (RID) for CLP-related exposure were low, well below 1%.

Conclusions:

• Infant exposure to clopidogrel (CLP) and its metabolites via breast milk appears to be low.
• Observed infant plasma concentrations support the low exposure estimates.
• Further studies are recommended to confirm CLP safety in breastfeeding infants due to variable infant pharmacokinetics.